DDrare: Database of Drug Development for Rare Diseases

97. 潰瘍性大腸炎
［臨床試験数：2,269，薬物数：1,331（DrugBank：241），標的遺伝子数：114，標的パスウェイ数：181］

Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (-)-3-(4-Aminophenyl)-2-methoxypropionic acid; (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid; (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxyben; (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride; -aminosalicylic acid; 0.25 mg RPC1063; 0.25mg RPC103; 0.25mg RPC1063; 0.5 mg RPC1063; 1 mg RPC1063; 1.0 mg RPC103; 1.0 mg RPC1063; 1.Remicade; 10 mg Natura-alpha capsule; 100; 100 mg; 150 mg; 1500mg mesalazine pellets; 15N2-tofacitinib; 2 x 10 mg Natura-alpha capsules; 2'-Fucosyllactose; 2-Hydroxybenzoic acid; 20 mg; 225mg SHP647 (PF-00547659); 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM); 25 mg Ontamalimab; 250mg mesalazine pellets; 2L polyethylene glycol/ascorbic acid; 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III); 331731-18-1; 40 mg MSB11022; 42942019; 450 mg; 5 ASA, enemas, suppositories, corticosteroids; 5-ASA; 5-ASA (5-Aminosalicylate); 5-ASA MMx; 5-AminoSalicylic Acid; 5-Aminosalicyclic acid; 5-Aminosalicylic Acid; 5-Aminosalicylic acid; 5-Aminosalicylic acid (5-ASA); 5-Aminosalicylic acid(5-ASA) and/or Prednisone; 5-HTP; 5-amino salicylic acid; 5-amino salicylic acid (5-ASA); 5-amino-2-hydroxybenzoic acid; 5-aminosalicylate (Pentasa, Ferring); 5-aminosalicylic acid; 5-aminosalicylic acid (5-ASA); 50 mg; 500mg mesalazine pellets; 549-0261/F02-01; 6 mercaptopurine; 6-MP; 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid; 6-mercaptopurine; 75 mg Ontamalimab; 750mg mesalazine pellets; 75mg SHP647 (PF-00547659); 90 mg hydrocortisone acetate suppository with Sephure suppository applicator; A multistrain probiotic product (DSF); A07DA03; A: 1 dosis; AB (antibiotics); ABBV-006; ABBV-066; ABBV-323; ABBV-323 Dose A; ABBV-323 Dose B; ABI-M201; ABT-494; ABT-Humira; ABX464; ABX464 100mg; ABX464 25mg; ABX464 50mg; ADALIMUMAB; AEB071; AEB071A; AG011; AG011 - Capsules; AG011 - Enema; AJG501; AJG511; AJM300; ALLOPURINOL; ALTH12-1:4; ALTH12-2:4; AMG 181; AMG181; AMGEVITA; AMGEVITA (Adalimumab biosimilar ); AMGEVITA®; AMT; AMT-101; AMT-101 (oral); AND (Andrographolide); ANDROGRAPHIS PANICULATA; ANDROGRAPHIS PANICULATA (ethanol extract); AODG (Apigenin-7-O-glucuronide); APD334; APREMILAST; APRISO 375 mg extended-release capsules; APVO210; AR401959 L-arginine; AS; AS INN; ASA; ASACOL; ASC; ASP015K; ASP3291; AST-120; ATL-2502; AVONEX; AVX 470; AZA; AZAFOR 50mg; AZATHIOPRINE; AZATIOPRINA; AbGn-168H; Abalimumab; Abatacept; Abatacept (ABA); Abrilumab; Accelerated 1 hour-infusion; Accelerated 30 minutes-infusion; Acetate; Acetic acid; Acidophilus; Active group; Adalimumab; Adipate; Adipose derived, autologous mesenchymal stem cells; Adipose tissue-derived mesenchymal stem cells; Adipose-cord mesenchymal stromal cells (A-MSCs); Air; Aldesleukin; Alicaforsen; Alkaline Phosphatase; Allogeneic adipose tissue-derived mesenchymal stem cells; Allopurinol; AloASC; Aloe; Aloe Barbadensis Miller; Amg 181; Amgevita; Amgevita 40 mg Injektionslösung im Fertigpen; Amgevita 40 mg Injektionslösung in einer Fertigspritze; Amgevita 40Mg Solution for Injection; Aminosalicylic acid; Amitriptyline; Amitriptyline hydrochloride; Amoxicillin; Amoxicillin and tetracycline; Amoxicillin, metronidazole and tetracycline; Anakinra; Andecaliximab; AndoSan; Andrographolide; Anrukinzumab; Anti Beta7; Anti CD3 monoclonal antibody; Anti TNF therapy including infliximab; Anti-CD3; Anti-CD3 monoclonal antibody; Anti-IP-10 Antibody; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human; Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; Anti-MAdCAM antibody; Anti-TL1A; Anti-TNF Drug; Anti-TNF Therapy; Anti-TNF discontinuation: Physiological saline solution; Anti-TNF: Infliximab (Infusion); Anti-TNF:Adalimumab (Subcutaneus); Antibiotic cocktail; Apigenin; Apixaban; Apixaban 2.5 milligram; Apremilast; Apriso 0.375G ER CAP; Aquamin®; Arginine; Asacol; Asacol (mesalamine); Asacol (mesalamine) Delayed-release Tablets; Asacol 400 mg; Asacol 400 mg (mesalamine); Asacol 400 mg tablet; Asacol 400mg tablet; Asacol 800 mg (mesalamine); Asacol 800 mg tablet; Asacol 800mg tablet; Asacol Delayed Release Tablets; Asacol Delayed-Release Tablets; Asacol tablet; Asacol®; Asacol® 400 mg; Ascorbic Acid; Ascorbic acid; Aspergillus oryzae; Avonex; Azathioprine; Azathioprine (AZA); Azathioprine (AZA) or 6-mercaptopurine (6-MP); Azathioprine (Imuran) 50 mg Overencapsulated Tablet; Azathioprine and Allopurinol; Azathioprine or 6-mercaptopurine; Azatioprina; B2-ASmedic; B: 2 dosis; BBT-401-1S; BBT-401-1S, Multiple doses; BBT-401-1S, Single dose; BECLOMETASONE DIPROPIONATE; BG9418 (Interferon beta-1a); BG9924; BI 655130; BIAP; BITTER CANDYTUFT FRESH PLANT EXTRACT; BL-7040; BMS-188667; BMS-936557; BMS-986165; BMS-986165 Dose 1; BMS-986165 Dose 2; BMS-986166; BMS-986184; BMS986165; BRAZIKUMAB; BT-11; BT-11 (1000 mg); BT-11 (500 mg); BT-11 1000mg; BT-11 500 mg; BT-11 Active; BUDESONIDE; Bacteriotherapy; Balsalazide; Balsalazide Disodium; Balsalazide disodium; Baminercept; Band; Bascial prescription plus or minus herbs depend on symptoms; Basiliximab; Beclometasone; Beclometasone dipropionate; Beclomethasone dipropionate; Beclomethasone diproprionate; Behavioral: AbbVie Care 2.0; Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus); Behavioral: Increased dietary intake of salmon or cod; Behavioral: TIP / IMPACT Plus Care Coordination; Berberine; Berberine Chloride; Bertilimumab; Beta-1,3/1,6-D-Glucan; Bezlotoxumab; Bifidobacterium breve; Bifidobacterium infantis; Bifidobacterium infantis 35624; Bimekizumab; Bio-enhanced Curcumin Soft Gelatin Capsule; Biologically active human fecal microbiota; Biopsies; Biosimilar; Biosimilar infliximab; Bitterschleifenblume-ganzpflanze 1,5ml/10ml; Blood sample; Blood samples; Boulardii; Bovine intestinal alkaline phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase (BIAP); Bovine-Calf Alkaline Phosphatase BIAP; Brazikumab; Broccoli; Budenofalk 2mg rectal foam; Budenofalk 3mg; Budenofalk rectal foam; Budenofalk® suppositories; Budenofalk® suppositories (BUS); Budesonide; Budesonide (6 mg); Budesonide (9 mg); Budesonide 6 mg capsules, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide 9 mg capsules, hard (BUX-PV); Budesonide 9 mg capsules, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype); Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype); Budesonide MMX; Budesonide MMX 6 mg Tablet; Budesonide MMX®; Budesonide MMX® 6 mg; Budesonide MMX® 9 mg; Budesonide-MMX; Budesonide-MMX®; Budesonide-MMX® 6 mg; Budesonide-MMX® 9 mg; Budesonide-MMX™; Butanoic acid; Butyrate; By demand; CANNABIDIOL; CARVI EXTRACTUM FLUIDUM; CAT-354; CB-01-02; CB-01-05-MMX; CC; CC-10004; CD; CGMP protein; CICLOSPORIN; CLA; CLA (Chlorogenic acid); CLIPPER*30CPR 5MG R.M.; CNTO 148; CNTO-148; CNTO1275; CNTO148; CNTO1959; CNTO312; COFFEE COAL; COLAL PRED; COLAL-PRED; COLAL-PRED®; CP; CP- 690 550; CP-690,500 5 mg; CP-690,550; CP-690,550 10 mg; CP-690,550-10; CP690,550; CS (corticosteroids) Only; CT-P13; CT-P13 SC (Infliximab); CYCLOSPORIN; CYCLOSPORINE VS INFLIXIMAB; Caffeine; Caffeine 100 mg; Calcitonin nasal spray (salmon); Calcium; Caltrate Pill; Cannabidiol; Cannabis; Cannabis, Medical; Carbon; Carbon dioxide; Carnitine; Carrageenan; Casein; Casein glycomacropeptide (CGMP); Catridecacog; Ceftriaxone; Cefuroxime; Certolizumab pegol; Chloride; Chlorogenic Acid; Cholecalciferol; Ciclosporin; Ciclosporina; Cimzia; Ciprofloxacin; Clarithromycin; Clipper; Clipper 30 cpr 5mg R.M.; Clotrimazole; Coamoxiclav; Cobitolimod; Coffee; Colal-Pred; Colazide; Coltect; Combination Oral Budesonide and Rectal Hydrocortisone; Combination Product: Beclomethasone dipropionate in addition to MC-EVOO; Combination Product: Beclomethasone dipropionate in addition to refined oil; Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator; Corticosteroid; Corticosteroids; Corticosteroids only; CortimentMMX 9 mg; CosmoFer; CosmoFer 50mg/ml solution for infusion or injection; Cotrimoxazole; Curcumin; CyCol; CyCol™; Cyclosporin; Cyclosporine; Cyclosporine (USAN); Cytochrome P450 (CYP) Substrates; D-Proline; DACORTIN; DAND (14-Deoxyandrographolide); DDAND (14-deoxy-11,12-didehydroandrographolide); DELTACORTENE FORTE*10CPR 25MG; DELTACORTENE*20CPR 5MG; DEXTRAN 1 FOR INJECTION; DIMS0150; DIMs0150; Daclizumab; Dacortin; Decortin H; Decortin H 1 mg; Decortin H 10mg; Decortin H 20mg; Decortin H 50 mg; Decortin H 5mg; Dekavil; Dekristol; Delayed and extended release mesalazine; Deligoparin; Delmitide acetate; Deltacortene; Deltacortene 10 cpr 25mg; Deltacortene 20 cpr 5mg; Dersalazina sodica; Dersalazine; Dersalazine sodium; Device: The Colonic Transendoscopic enteral Tubing.; Dexamethasone; Dexamethasone 21-phosphate; Dextran; Dextromethorphan; Dextromethorphan 30 mg; Diagnostic Test: Antibodies to golimumab; Diagnostic Test: Calprotectin; Diagnostic Test: Colonoscopy; Diagnostic Test: Golimumab trough levels; Diagnostic Test: Histology; Diagnostic Test: Rectosigmoidoscopy; Diagnostic Test: parasitological diagnostics (coproscopy); Diagnostic Test: serum leucine-rich alpha-2 glycoprotein (LRG) levels; Diet; Doxycycline; Dukoral; E. coli Nissle; E6007; EGF enema; EMEA/H/C/000240; EMEA/H/C/000481; EN; ENTOCORT CR; ENTYVIO; ETROLIZUMAB; Ecologic 825; Eicosapentaenoic Acid; Eicosapentaenoic acid; Encapsulated Mesalamine Granules (eMG); Encapsulated faecal microbiota; Encapsulated faecal microbiota filtrate; Entecavir; Entocort EC® 3 mg; Entocort® CR; Entyvio; Entyvio 300 mg; Entyvio 300mg; Epaxal Berna (virosomal hepatitis A vaccine); Epidermal growth factor; Epidermal growth factor enema; Ergocalciferol; Ethanol; Etrasimod; Etrasimod L-arginine; Etrolizumab; Etrozulimab; Exposure to golimumab; F8IL10; FE 999301; FILGOTINIB; FITC-ADALIMUMAB; FITC-Adalimumab; FMT; FMT enema; FMT infusions; FMT oral; FP-110; FP-CYA-050; FP-CYA-053; Factor XIII; Faecal Microbiota Transplant; Faecal Microbiota Transplantation; Faecal matter; Fecal Microbial Transplant; Fecal Microbial Transplantation; Fecal Microbiota; Fecal Microbiota Enema; Fecal Microbiota Transplant; Fecal Microbiota Transplant (FMT); Fecal Microbiota Transplantation; Fecal Microbiota Transplantation (FMT); Fecal Microbiota Transplantation (FMT), OpenBiome; Fecal microbiota; Fecal microbiota capsule; Fecal microbiota transplantation; Ferric carboxymaltose; Ferrous sulphate; Filgotinib; Film-coated tablet; Flagyl; Flaxseed; Flaxseed lignan-enriched complex (FLC); Flixabi; Fluorescein; Flupentixol; Fosfomycin; Freeze-dried black raspberry powder; G321605; GB004; GED-0301; GED-0507-34-LEVO; GED-0507-34-Levo; GED-0507-34-Levo 160 mg; GED-0507-34-Levo 80 mg; GED0507; GI-270384; GLPG0974; GLPG1205; GLPG3970; GLYCYRRHIZA GLABRA ROOT; GOLIMUMAB; GS-4875; GS-5745; GS-5745 IV; GS-5745 SC; GS-6034; GSK1399686; GSK1605786; GSK1605786A; GSK2586184 400mg; GSK2831781; GSK2831781 IV infusion; GSK2831781 SC injection; GSK2982772; GSK2982772A, where A denotes the free base; GUSELKUMAB; GWP42003; Ganciclovir; Gastro-resistant phosphatidylcholine granules; Gelatin; Genetic: TPMT genotyping; Gliolan; Glutamine; Glycyrrhiza; Glycyrrhiza glabra; Gold; Golimumab; Golimumab (GLM); Golimumab (Optimization); Golimumab 1 mg per kg; Golimumab 100 mg; Golimumab 2 mg per kg; Golimumab 200 mg; Golimumab 4 mg per kg; Golimumab 400 mg; Golimumab 50 mg; Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg; Golimumab Dose 1; Golimumab Dose 2; Golimumab Liquid in Vial; Golimumab Liquid in prefilled syringe; Golimumab Prefilled Syringe; Golimumab treatment optimization.; Gralise; Granulated mesalamine; Grapefruit; Group 1- Control Diet; Group 2- UCD Diet; Guaiazulene; Guselkum; Guselkumab; Guselkumab Dose 1; Guselkumab Dose 2; H02AB; HE3286; HF2; HGS1025; HMPL-004; HMPL-004 1800 mg/day; HMPL-004 2400 mg/day; HMPL-004 high dose; HMPL-004 low dose; HMPL004-6599; HUMIRA; HUMIRA 40Mg Solution for Injection; HUMIRA ®; HYDROCORTISONE ACETATE; Hemay007; Hepatitis A Vaccine; Herbal treatment (SA100); Hextend; Hgd40; High Dose Budesonide; High dose; HuM291; HuM291); Hulio; Human Anti-TNF IgG1 Monoclonal Antibody; Human Anti-TNFalfa; Human anti-IP10 monoclonal antibody; Human anti-TNF-alpha monoclonal antibody; Humanized recombinant IgG4 monoclonal antibody against CD-127; Humira; Humira (adalimumab original); Humira 40 mg solution for injection in pre-filled syringe; Humira 40 mg solution for injection in pre-filled syringes; Humira 40 mg/0.8 ml solution for injection; Humira 40 mg/0.8 ml solution for injection for paediatric use; Humira®; Hyaluronate; Hydrocortisone; Hydrocortisone acetate; Hydrocortisone sodium succinate; Hydrogen; Hydroxide; Hydroxocobalamin; Hydroxocobalamin with Butyrate; IBD98-M; IBD98-M Delayed-release Capsules; IDOFORM®Travel; IM90838; IMU-838; INCB039110; INFLIXIMAB; INTERLEUKIN 2; INTERLEUKIN-2; ITACITINIB ADIPATE; IV Corticosteroid; Iberogast N; Imolope; Impact; Imuran; Imurek; Imurek 25mg Filmtabletten; Imurek 50mg Filmtabletten; Imurel; Inflectra; Inflectra 100 mg; Inflectra 100 mg powder for concentrate for solution for infusion; Infliximab; Infliximab (IFX); Infliximab 10 mg/kg; Infliximab 5 mg/kg; Infliximab [infliximab biosimilar 3]; Infliximab and adalimumab; Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab; Infliximab, adalimumab, certolizumab pegol; Innovator infliximab; Inositol; Interferon beta; Interferon beta-1a; Interferon-beta; Interferon-beta-1a; Interferon-beta-1a, 44 microgram; Interferon-beta-1a, 66 microgram; Interleukin 2; Interleukin-2 (aldesleukin).; Iron; Iron Sucrose; Iron sucrose; Iron sulphate; Iron sulphate 200mg coated tablets; Iron supplement 300-600 mg/day; Iron(III)- hydroxide dextran complex; Itacitinib; JNJ-54781532 150 mg once daily; JNJ-54781532 25 mg once daily; JNJ-54781532 75 mg once daily; JNJ-54781532 75 mg twice daily; JNJ-54781532-AAD-10 mg; JNJ-54781532-AAD-30 mg; JNJ-54781532-AAD-5 mg; JNJ-66525433; K(D)PT; KHK4083; KRP203; KRP203A; Kamillenblüten 3ml/10ml; Kappaproct; KdPT; Kremezin; Kremezin®, Spherical Adsorptive Carbon; Kyo-Dophilus; Kümmel 2ml/10ml; L-Carnitine; L-Lysyl-D-Prolyl-L-Threonine Acetate; L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate; LC51-0255; LDP-02; LIXACOL; LOPERAMIDE; LT-02; LT-02 (modified-release PC pellets); LX1606; LY3074828; LYC-30937; LYC-30937-EC; LYS006; Lactated Ringers; Lactobacillus GG; Lactobacillus casei DG; Lactobacillus plantarum; Lactobacillus reuteri; Lactobacillus rhamnosus GG ATCC 53103; Lactobacillus salivarius UCC118; Lactobacilus acidophilus & bifidobacterium animalis/lactis; Lactose; Lactose in water; Leucine; Levocarnitine; Levocarnitine propyl hydrochloride; Linaclotide; Lixacol; Loperamide; Loperamide hydrochloride; Losartan; Low Dose Budesonide; Low FODMAP; Low dose; Low dose naltrexone; Lumbar puncture; Lysine; Lysine-D-Proline-Threonine; Lysine-D-proline-threonine; MATRICARIA FLOWER; MATRICARIA RECUTITA L. FLOS; MD-0901; MDX-1100; MDX-1100 (anti-CXCL10 human monoclonal antibody); MEDI7183 high dose; MEDI7183 low dose; MEDI7183 medium dose; MELISSAE FOLII DRY AQUEOUS EXTRACT; MENTHA × PIPERITA L. FOLIUM; MERCAPTOPURINE; MESALAZINA; MESALAZINE; MESENCHYMAL CELLS; MET-2; METHOTREXATE; METHOTREXATE DISODIUM; METHYLENE BLUE; METHYLPREDNISOLONE SODIUM HEMISUCCINATE; MEZAVANT; MIRIKIZUMAB; MK-8259; MLN0002; MLN0002 (Vedolizumab); MLN0002 SC; MLN002; MMX Mesalamine; MMX Mesalamine/Mesalazine; MMX Mesalamine/Mesalazine (High Dose); MMX Mesalamine/Mesalazine (Low Dose); MMX mesalamine/ mesalazine; MONOCLONAL ANTIBODY ANTI-IGG1; MSC; MTX; MTX 12.5; MTX 25; MYRRH; Magnesium; Magnesium citrate; Maltodextrin; Maltose; Mango; Mango polyphenolics; Mare´s milk; Matricaria Flower; Maximal oral 5ASA; Melatonin; Melissenblätter 15ml/10ml; Melitracen; Mercaptopurine; Mercaptopurine (Puri-Nethol); Mercaptopurine (Purinethol); Mesalamin; Mesalamine; Mesalamine Delayed Release Tablets 400mg; Mesalamine Enema; Mesalamine Granules; Mesalamine Once-Daily; Mesalamine Twice-Daily; Mesalamine granules; Mesalamine, 5-ASA; Mesalamine, 5-aminosalicylic acid [5-ASA]; Mesalazina; Mesalazine; Mesalazine (3,600 mg); Mesalazine (Asacol®); Mesalazine - TID 1000 mg; Mesalazine - TID 2x 500 mg; Mesalazine 1000 mg gastro-resistant tablets; Mesalazine 250Mg; Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet; Mesalazine 4G Enema; Mesalazine 500 mg gastro-resistant tablets (Salofa; Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg); Mesalazine Enema; Mesalazine enema; Mesalazine liquid enema; Mesalazine slow-release granules; Mesalazine tablet; Mesalazine with hydrocortisone sodium succinate; Mesalazinum; Mesenchymal Stromal Cells; Mesenchymal stromal cells; Methotrexate; Methotrexate bellon; Methotrexate bellon 25mg/ml; Methotrexate injection; Methylene blue; Methylene blue 25mg tablets; Methylprednisolone; Metoject; Metronidazole; Metronidazole capsule 50 mg; Mezavant; Mezavant 1200 mg magensaftresistente Retardtabletten; Mezavant Gastro-resistant, prolonged release tablets; Mezavant XL; Mezavant XL 1200 mg gastro-resistant prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets; Mezavant XL 1200 mg gastro-resistant, prolonged release tablets.; Mezavant XL 1200mg gastro-resistant, prolonged release tablets; Mezavant XL Gastro-resistant, prolonged release tablets; Midazolam; Midazolam 2 mg; Mirikizumab; Mirikizumab IV; Mirikizumab SC; MitoQ; Modified Gegen Qinlian Decoction; Modified-release phosphatidylcholine; Mongersen; MultiStem; MultiStem high dose; MultiStem low dose; Multiple dose- Group B; Multiple dose-Group B; Multistem; Mycodigest supplement; Myrrh; Myrrhinil-Intest®; N.a.; NAND (Neoandrographolide); ND; NEORAL; NX-13 250 mg; Naltrexone; Nanocort; Neomycin; Neoral Soft Gelatin Capsules; Niclosamide; Nicolon; Nitazoxanide; Nitazoxanide 500Mg Oral Tablet; Nivolumab; Nolpitantium Besylate; Nolpitantium besylate; Non as of yet; None; None given; Normal Saline Enema; Null; Nutrition supplement; Nutritional dietary intervention; Nuvion®); OPC-6535; OPC-6535 Tablets (drug); OPC-6535(Tetomilast); OPRX-106; OPRX-106 (plant cells expressing TNFR-Fc) 2mg; OPRX-106 (plant cells expressing TNFR-Fc) 8mg; ORE1001; OSE-127; OST-122; Oats; Omeprazole; Omeprazole 20 mg; Ondansetron; Ondansetron hydrochloride dihydrate; Ontamalimab; Oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone; Oral Corticosteroids; Oral OKT3; Orencia; Originator (legacy) drug; Oseltamivir; Other: 0 mg; Other: 100% pomegranate juice; Other: Additional Therapies; Other: Control; Other: Control group(Normal saline); Other: Conventional drugs; Other: Faecal bacterial transplantation; Other: Fast Mimicking Diet; Other: Hyperbaric Oxygen Therapy; Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis; Other: Intensify treatment with the existing drug; Other: Laboratory Biomarker Analysis; Other: Measurement of drug (Adalimumab/Infliximab); Other: Mesalazine; Other: Other Biologic Agents; Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA); Other: Saline; Other: Therapy Education; Other: Threonine; Other: Ulcerative Colitis Diet; Other: dietary intervention with no-carrageenan diet; Other: e-Monitoring; Other: pretreatment antibiotics; Overencapsulated Azathioprine (Imuran) 50 mg Tablet; Overencapsulated mesalazine tablets; Oxygen; Ozanimod; Ozanimod hydrochloride; PARNAPARIN SODIUM; PBF-677; PCT (PureCell Technologies Complex); PEG; PEG-liposomal prednisolone sodium phosphate; PF 06687234; PF-00547659; PF-00547659 SC Injection; PF-05230917; PF-05285401; PF-06480605; PF-06480605 100 mg/ml; PF-06651600; PF-06651600 10 mg; PF-06651600 50 mg; PF-06651600-15; PF-06687234; PF-06700841; PF-06700841 25 mg; PF-06700841 5 mg; PF-06700841-15; PF-06826647; PF-06826647 100 mg QD; PF-06826647 300 mg QD; PF-06826647 600 mg QD; PF-6826647 400 mg QD; PN-10884A; PN-943; PRD5973697; PREDNISOLONE; PREDNISOLONE SODIUM PHOSPHATE; PREDNISONE; PRIM-DJ2727; PRO145223; PRO145223 (RO5490261); PROPIONYL L-CARNITINE; PROPIONYL L-CARNITINE HYDROCHLORIDE; PRV-300; PS; PS-QD; PS-SP; PTG-100; PUR 0110; PUR 0110 Rectal Enema; PUR 0110 Rectal Enema 1000 mg; PUR 0110 Rectal Enema 250 mg; PUR 0110 Rectal Enema 500 mg; PV; Palmitoleic Acid; Palmitoleic acid; Parnaparin; Pending; Pentasa; Pentasa 2g sachet prolonged release granules (95%); Pentasa 500 mg Retardtabletten; Pentasa Compact 2g, granulate with prolonged release; Pentasa Compact 4g, granulate with prolonged release; Pentasa Sachet; Pentasa Sachet 1 g; Pentasa Sachet 1g; Pentasa Sachet 2 g; Pentasa enema; Pentasa prolonged release granules 2g; Pentasa sachet 1g; Pfefferminzblätter 1ml/10ml; Phosphate; Phosphatidylcholine; Photodynamic therapy with Gliolan; Picosulfate; Placebo; Polaprezinc; Polyethylene glycol; Polyphenon E®; Pomegranate; Prednisolon; Prednisolon Jenapharm; Prednisolone; Prednisolone Sodium Phosphate; Prednisolone Tablets B.P. 5mg; Prednisolone sodium metasulphobenzoate; Prednisone; Prefilled Syringe delivery of Golimumab; Previously referred to as MEDI2070 and AMG 139; Probiotic; Probiotic Formula Capsule; Probiotic Mixture; Probiotics; Procedure: Biopsies; Procedure: Blood sampling, endoscopy; Procedure: Colectomy; Procedure: Colonoscopy; Procedure: Colorectal biopsies; Procedure: Enema; Procedure: FMT; Procedure: Fecal microbiota transplantation; Procedure: Gastroscopy; Procedure: Hyperbaric oxygen; Procedure: Infusion of Saline; Procedure: Narrow Band Imaging; Procedure: Rectal dialysis; Procedure: Sham Hyperbaric Air; Procedure: Standardized FMT; Procedure: Stool samples; Procedure: colonoscopy; Procedure: lumbar puncture; Procedure: rectosigmoidoscopy; Procedure: sigmoidoscopy; Products containing aminosalicylate; Products containing azathioprine or 6-mercaptopurine; Proline; Promiten; Propionyl-L-Carnitine; Propionyl-L-carnitine; Propionylcarnitinhydrochlorid; Psyllium; Psyllium Husk Powder; Psyllium husk; Puri-Nethol; QBECO SSI; RAVAGALIMAB; RDP58; RECTABUL2mg rectal form; REMICADE; REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO; RIBOFLAVIN; RISANKIZUMAB; RO5490261 / F02; RO5490261/F02; RO5490261/F04-02; RO7049665; RO7246311; ROSUVASTATIN CALCIUM; RPC1063; RTNV148B IgG; Raspberry; Ravagalimab; Rebamipide; Recombinant Factor XIII (rFXIII); Rectal dialysis; Rectal tacrolimus; Regular treatment; Remestemcel-L; Remicade; Remicade (infliximab); Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten; Remicade 100 mg powder for concentrate for solution for infusion.; Remicade 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima; Remsima (CT-P13); Remsima (infliximab); Remsima 100 mg pulver til konsentrat til infusjonsvæske, oppløsning; Remsima and Inflectra; Retarded Release Phosphatidylcholine (rPC); Retarded release phosphatidylcholine; RhIL-11; RhuMAb Beta7; RhuMAb Beta7, Anti Beta 7, PRO145223; RhuMAb Beta7, Anti Beta7, PRO145223; RhuMab Beta7, Anti Beta7, PRO145223; Riboflavin; Rifaximin; Risankizumab; Risankizumab (Genetical Recombination); Risankizumab IV; Risankizumab SC; Rituximab; Rivenprost; Rivenprost (drug); Ro 549-0261/F04; Rosiglitazone; Rosuvastatin; Rosuvastatine EG; SANDINUM; SAR339658; SB-656933; SB-656933 Tablets; SB012; SB5; SC12267; SC12267 (4SC-101); SCH 900050; SER-287; SF257 C59; SHINGRIX; SHP647; SHR0302; SIMPONI; SODIUM HYALURONATE; SOYBEAN PHOSPHATIDYLCHOLINE; SPD476; SPD476 (mesalazine); SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine; SPESOLIMAB; SR140333B; SRT2104; ST 261; ST-0529; ST10-021; ST261; STELARA®; STNM01; STNM01 1.84 mg; STW5-II; STW5-II (Iberogast N, BAY98-7410); SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML; Salicylic acid; Saline; Salmon; Salofalk; Salofalk 1000mg Granu-Stix; Salofalk 1000mg Granu-Stix®; Salofalk 1000mg Granu-stix®; Salofalk 3g gastro-resistant prolonged-release granules; Salofalk 4g/60ml Klysma; Salofalk Granu-Stix 500 mg; Salofalk® 1000mg Granu-Stix®; Salofalk® 500 mg gastro-resistant tablet; Salofalk® 500 mg tablets; Salofalk® 500mg; Salofalk® 500mg Granu-Stix®; Sandimmum; Sandimmun; Sandimmun 50 mg/ml, infuusiokonsentraatti; Sandimmun Neoral; Semi-vegetarian diet; Serum bovine immunoglobulin; Shingrix; Simponi; Simponi (Golimumab); Simponi®; Simponi® (Golimumab); Simulect; Single dose-group A; Smartject Device delivery of Golimumab; Smoking cigarettes; Smoking of cannabis; Sodium Picosulfate/Magnesium Citrate Laxative; Solu-Medrol; Solu-medrol; Sotrastaurin; Sotrastaurin (INN) acetate; Soybean; Spesolimab; Spesolimab IV infusion; Spesolimab SC solution for injection; Standard 2 hours-infusion; Standard Therapy; Standardized FODMAP; Standardized anthocyanin-rich extract; Stasis; Stelara; Sterile saline for injection; Steroids; Sucrose; Sugar Extract; Sulphsalazine, Pentasa, Asacol, Colazide, Depentum; Suspension de microbiote fécal; Synergy-1; Synergy1; Sübetaholzwurzel 1ml/10ml; Süßholzwurzel 1ml/10ml; TA-650; TA-650 (Infliximab); TD-1473; TD-1473 Dose A; TD-1473 Dose B; TD-1473 Dose C; TD-3504; THRX-139060; TJ301 300mg; TJ301 600mg; TOFACITINIB; TOP1288; TOP1288 Rectal solution; TOP1288 rectal solution; TP05; TP05 Coating A; TP05 Coating B; TP05 Coating D; TP05 Coating E; TP05 Coating H; TREMFYA®; TSO; Tacrolimus; Tauroursoursodeoxycholic acid, brand name Tudcabil; Telotristat; Telotristat Etiprate; Telotristat etiprate; Terbinafine; Tetomilast; Tetracycline; Thalidomide; Thalidomide Pharmion; Threonine; To be confirmed; To be requested; Tofacitinib; Tofacitinib citrate; Tofacitinib citrate (Phase III Formulation); Tofacitinib citrate (Proposed commercial formulation - debossed); Tofacitinib citrate (Proposed commercial formulation – debossed); Tofacitinib citrate (Proposed commercialFormulation - debossed); Tofacitinib citrate (clinical trial image); Traditional treatments; Tralokinumab; Treatment Algorithm A; Treatment Algorithm B; Treatment Algorithm C; Tremfya; Trexan; Trexan inj 25 mg/ml; Trichuris suis eggs; Trichuris suis ova; Trichuris suis ova (TSO); Tris; UCB4940; UCMSC group; UDCA; UR-12746-S; USTEKINUMAB; UTTR1147A; UTTR1147A, IL22-Fc, IL-22Fc; UTTR1147A/RO7021610 (Active); Umbilical Cord Mesenchymal Stem Cells; Unknown; Upadacitinib; Upadacitinib (ABT-494); Upadacitinib - Direct compression-yellow; Upadacitinib - Wet Granulation-Yellow; Upadacitinib -Direct compression-yellow; Updacitinib (ABT-494); Urbason; Ursodeoxycholic acid; Ursodiol; Ursodiol (ursodeoxycholic acid, UDCA); Ursofalk; Ustekinumab; Ustekinumab Dose Based on BSA and Body Weight; Ustekinumab IV; Ustekinumab IV Infusion; Ustekinumab SC; Ustekinumab SC Injection; Usual current care; V565; VB-201; VB-201 160mg; VEDOLIZUMAB; VSL#3; VSL#3 (Original De Simone formulation); VSL#3®; Vaccine Vivotif + Vaccine Dukoral; Vaccine Vivotif + Vaccine Dukoral + oats; Valganciclovir; Vaminolac; Vaminolac, komb.; Vamorolone; Vamorolone 4% suspension for oral dosing; Vancomycin; Vancomycin Pre-Treat; Vancomycin Pre-Treatment; Vatelizumab; Vedolizumab; Vedolizumab 108 mg SC; Vedolizumab 300 mg; Vedolizumab 300 mg IV; Vedolizumab IV; Vedolizumab IV, Placebo IV, Placebo SC; Vedolizumab IV, Placebo SC; Vedolizumab Injection; Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV; Vedolizumab SC; Vedolizumab SC 108 mg; Vedolizumab intravenous injection; Vedolizumab subcutaneous injection; Vidofludimus; Vidofludimus calcium; Vidofludimus calcium dihydrate; Vigantol; Vigantol Oel; Vigantol Oel TM; Visilizumab; Visilizumab (HuM291; Visilizumab (Nuvion); Visilizumab (Nuvion®; Vitamin B2; Vitamin D; Vitamin D drops; Vitamin D3; Vitamin E; Vitamin E 800IU; Vitamin K; Vitamin K 10 mg; Vivotif; Warfarin; Warfarin 10 mg; Water; Wharton Jelly Mesenchymal stem cells; XELJANZ; Xeljanz; Xeljanz 5 mg film-coated tablets; Xeljanz 5mg film-coated tablets; Z-206; Zessly; Zoenasa-1:4; [124I]IB PF 06687234; [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration; [18F]FSPG; [BI 655130]; [CC-10004]; [N/A]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04469062 (ClinicalTrials.gov)	April 20, 2021	10/7/2020	A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis	A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SC	Eli Lilly and Company	NULL	Not yet recruiting	18 Years	80 Years	All	1100	Phase 3	NULL
2	NCT04314375 (ClinicalTrials.gov)	April 2021	17/3/2020	Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo	Bausch Health Americas, Inc.	NULL	Not yet recruiting	5 Years	17 Years	All	70	Phase 4	NULL
3	NCT04596293 (ClinicalTrials.gov)	January 31, 2021	15/10/2020	Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis	A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase	Ulcerative Colitis	Drug: BBT-401-1S;Drug: Placebo	Bridge Biotherapeutics, Inc.	Covance	Not yet recruiting	18 Years	60 Years	All	36	Phase 2	NULL
4	NCT04630028 (ClinicalTrials.gov)	January 8, 2021	13/11/2020	A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)	A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching Placebo	Janssen Research & Development, LLC	NULL	Not yet recruiting	2 Years	17 Years	All	90	Phase 3	United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom
5	EUCTR2020-001398-59-HR (EUCTR)	02/12/2020	07/12/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: AS INN Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2019-002698-74-GB (EUCTR)	17/11/2020	30/03/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
7	NCT04613518 (ClinicalTrials.gov)	November 13, 2020	28/10/2020	A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis	Colitis, Ulcerative	Drug: BMS-986165 Dose 1;Drug: BMS-986165 Dose 2;Other: Placebo Comparator	Bristol-Myers Squibb	NULL	Not yet recruiting	18 Years	65 Years	All	50	Phase 2	Australia;Canada;Germany;Netherlands;Puerto Rico
8	NCT04607837 (ClinicalTrials.gov)	November 10, 2020	23/10/2020	Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis	Ulcerative Colitis	Drug: Etrasimod;Drug: Placebo	Arena Pharmaceuticals	NULL	Not yet recruiting	18 Years	80 Years	All	162	Phase 2	NULL
9	NCT04543994 (ClinicalTrials.gov)	November 10, 2020	3/9/2020	Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)	A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis	Ulcerative Colitis	Drug: Remestemcel-L;Other: Placebo	The Cleveland Clinic	Mesoblast, Inc.	Recruiting	18 Years	75 Years	All	24	Phase 1;Phase 2	United States
10	ChiCTR2000038888	2020-10-19	2020-10-09	Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial	A systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility	Ulcerative colitis	control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;	Chengdu University of Traditional Chinese Medicine	NULL	Recruiting	20	45	Female	control group:118;experimental group:118;		China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	NCT04556383 (ClinicalTrials.gov)	October 19, 2020	15/9/2020	A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)	A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis	Ulcerative Colitis	Drug: GB004;Drug: Placebo	GB004, Inc.	NULL	Recruiting	18 Years	N/A	All	195	Phase 2	United States
12	EUCTR2020-001398-59-BG (EUCTR)	13/10/2020	18/09/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 INN or Proposed INN: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
13	EUCTR2020-000047-31-FR (EUCTR)	07/10/2020	13/05/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT -101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of
14	NCT04577794 (ClinicalTrials.gov)	October 5, 2020	30/9/2020	A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: GLPG3970;Drug: Placebo	Galapagos NV	NULL	Recruiting	18 Years	64 Years	All	30	Phase 2	Georgia;Moldova, Republic of;Poland;Ukraine
15	NCT04353791 (ClinicalTrials.gov)	October 2020	24/3/2020	Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis	A Phase Ib/IIa, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Treatment With OST-122 in Patients With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe	Drug: OST-122;Drug: Placebo	Oncostellae S.L	NULL	Recruiting	18 Years	75 Years	All	32	Phase 1;Phase 2	Spain
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	EUCTR2020-001398-59-LV (EUCTR)	21/09/2020	28/07/2020	Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)	Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)	Moderate to severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: OSE-127 Product Code: OSE-127 Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127	OSE Immunotherapeutics	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia
17	NCT04223518 (ClinicalTrials.gov)	September 20, 2020	6/1/2020	Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)	Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease	Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease	Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo	Monisha Hitesh Shah	NULL	Recruiting	6 Years	30 Years	All	43	Early Phase 1	United States
18	NCT03996369 (ClinicalTrials.gov)	September 15, 2020	21/6/2019	Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Etrasimod;Drug: Placebo	Arena Pharmaceuticals	NULL	Recruiting	16 Years	80 Years	All	330	Phase 3	Georgia;Japan;Poland;Russian Federation;Thailand;Ukraine
19	EUCTR2020-000047-31-HU (EUCTR)	09/09/2020	07/07/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT -101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Netherlands;Moldova, Republic of
20	EUCTR2019-002698-74-DE (EUCTR)	08/09/2020	21/02/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	NCT04205643 (ClinicalTrials.gov)	September 2, 2020	18/12/2019	CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: CT-P13 SC (Infliximab);Other: Placebo SC	Celltrion	NULL	Recruiting	18 Years	75 Years	All	615	Phase 3	Poland
22	NCT04583358 (ClinicalTrials.gov)	August 26, 2020	16/9/2020	Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)	Ulcerative Colitis	Drug: AMT -101 (oral);Other: Placebo (oral)	Applied Molecular Transport	NULL	Recruiting	18 Years	80 Years	All	102	Phase 2	United States;Canada;Georgia;Hungary;Moldova, Republic of
23	EUCTR2019-003999-39-NO (EUCTR)	17/08/2020	29/04/2020	A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	moderate to severe ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06826647 Product Code: PF-06826647 INN or Proposed INN: PF-06826647	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	202	Phase 2	United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway
24	EUCTR2019-004469-41-DE (EUCTR)	11/08/2020	26/03/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
25	EUCTR2019-004469-41-BG (EUCTR)	11/08/2020	27/04/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
26	NCT04504383 (ClinicalTrials.gov)	August 5, 2020	5/8/2020	PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis	Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe	Drug: PN-943;Drug: Placebo	Protagonist Therapeutics, Inc.	NULL	Recruiting	18 Years	75 Years	All	150	Phase 2	United States;Bulgaria;Canada;Hungary;Korea, Republic of;Poland
27	EUCTR2020-000047-31-GB (EUCTR)	03/08/2020	20/04/2020	A study of AMT-101 in patients with Ulcerative Colitis.	A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: AMT -101 INN or Proposed INN: Not yet assigned Other descriptive name: AMT -101	Applied Molecular Transport Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	102	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of
28	NCT04469686 (ClinicalTrials.gov)	July 30, 2020	2/7/2020	Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories	3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis	Ulcerative Proctitis	Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicator	Cristcot LLC	Cristcot HCA LLC	Recruiting	18 Years	N/A	All	618	Phase 3	United States
29	EUCTR2019-003596-19-DE (EUCTR)	29/07/2020	29/07/2020	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.	A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum. - cessa	Ulcerative Colitis of the Rectum MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator INN or Proposed INN: HYDROCORTISONE ACETATE	Cristcot HCA LLC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	618	Phase 3	United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India
30	EUCTR2019-004469-41-AT (EUCTR)	27/07/2020	26/03/2020	A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)	A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis	Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers. MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PN-943 Other descriptive name: PN-943 Product Code: PN-943 Other descriptive name: PN-943	Protagonist Therapeutics, Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
31	NCT04373473 (ClinicalTrials.gov)	July 15, 2020	28/4/2020	Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis	A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis	Adults With Ulcerative Colitis	Drug: PRIM-DJ2727;Drug: Placebos	The University of Texas Health Science Center, Houston	NULL	Not yet recruiting	18 Years	N/A	All	58	Phase 2	NULL
32	NCT04458805 (ClinicalTrials.gov)	July 10, 2020	16/6/2020	Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers	A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers	Ulcerative Colitis	Drug: NX-13 250 mg;Drug: Placebo	Landos Biopharma Inc.	NULL	Active, not recruiting	18 Years	64 Years	All	56	Phase 1	Australia
33	EUCTR2018-003986-33-PT (EUCTR)	06/07/2020	28/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
34	EUCTR2018-004002-25-NL (EUCTR)	06/07/2020	17/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium
35	EUCTR2018-004694-27-FR (EUCTR)	06/07/2020	10/04/2020	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
36	NCT03935451 (ClinicalTrials.gov)	July 1, 2020	23/4/2019	Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease	A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study	IBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal Disorders	Drug: Apixaban 2.5 milligram;Drug: Placebo Oral Tablet	McMaster University	NULL	Not yet recruiting	18 Years	N/A	All	60	Early Phase 1	NULL
37	ChiCTR2000033953	2020-07-01	2020-06-18	Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)	Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)	Ulcerative colitis	Placebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059;	Jiangnan University	NULL	Pending			Both	Placebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20;		China
38	NCT04457960 (ClinicalTrials.gov)	July 1, 2020	1/7/2020	A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis	A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433	Healthy;Colitis, Ulcerative	Drug: JNJ-66525433;Drug: Placebo	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	60 Years	All	128	Phase 1	Georgia;Germany;Moldova, Republic of
39	NCT04209556 (ClinicalTrials.gov)	June 30, 2020	1/12/2019	A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis	A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative Colitis	Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD	Pfizer	NULL	Recruiting	18 Years	75 Years	All	202	Phase 2	United States
40	EUCTR2019-003334-16-DE (EUCTR)	26/06/2020	05/05/2020	Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis	Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis	acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE	Dr. Falk Pharma GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 3	Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
41	EUCTR2019-001430-33-DE (EUCTR)	18/06/2020	25/02/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
42	EUCTR2019-003849-15-HR (EUCTR)	05/06/2020	20/11/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
43	EUCTR2019-002698-74-BE (EUCTR)	03/06/2020	02/04/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
44	NCT04259060 (ClinicalTrials.gov)	June 2020	27/1/2020	Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis Research	Hydroxocobalamin Approach to Reduction of Nitrite With Butyrate for Ulcerative Colitis	Ulcerative Colitis	Drug: Hydroxocobalamin with Butyrate;Drug: Placebo with Butyrate	Joshua Korzenik	NULL	Not yet recruiting	18 Years	75 Years	All	42	Phase 2	United States
45	JPRN-JapicCTI-194980	22/5/2020	30/09/2019	A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC.	Janssen Pharmaceutical K.K.	NULL	recruiting	18		BOTH	950	Phase 2b;Phase 3	Japan, Asia except Japan, North America, Europe
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
46	EUCTR2019-002698-74-FR (EUCTR)	20/05/2020	24/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
47	EUCTR2019-001430-33-AT (EUCTR)	15/05/2020	31/01/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
48	EUCTR2018-004002-25-BG (EUCTR)	13/05/2020	24/02/2020	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
49	EUCTR2019-003849-15-ES (EUCTR)	12/05/2020	28/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
50	EUCTR2019-001430-33-GB (EUCTR)	05/05/2020	21/02/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 INN or Proposed INN: to be confirmed Product Code: GS-4875 INN or Proposed INN: to be confirmed	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	180	Phase 2	United States;Czechia;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Australia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
51	EUCTR2019-003113-34-NO (EUCTR)	04/05/2020	21/01/2020	Ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Hungary;Czech Republic;Poland;Russian Federation;Bulgaria;Germany;Norway
52	EUCTR2018-003278-28-BG (EUCTR)	22/04/2020	23/05/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
53	EUCTR2019-002698-74-HU (EUCTR)	15/04/2020	20/04/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
54	EUCTR2018-004002-25-DE (EUCTR)	07/04/2020	23/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
55	EUCTR2018-003986-33-AT (EUCTR)	07/04/2020	20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
56	EUCTR2017-003703-22-BG (EUCTR)	07/04/2020	06/02/2020	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Belarus;Portugal;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
57	EUCTR2019-003849-15-GR (EUCTR)	03/04/2020	02/04/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
58	EUCTR2019-003849-15-BG (EUCTR)	03/04/2020	07/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of
59	EUCTR2019-003849-15-FR (EUCTR)	03/04/2020	03/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
60	EUCTR2019-001430-33-FR (EUCTR)	02/04/2020	20/02/2020	A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis	A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis	ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-4875 Product Code: GS-4875	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 2	United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
61	NCT04276740 (ClinicalTrials.gov)	April 1, 2020	12/2/2020	MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis	Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC	Ulcerative Colitis Flare	Dietary Supplement: MitoQ;Other: Placebo	University of Edinburgh	JP Moulton Charitable Foundation;MitoQ	Not yet recruiting	18 Years	N/A	All	206	Phase 2	NULL
62	EUCTR2019-002698-74-ES (EUCTR)	01/04/2020	23/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
63	NCT04225819 (ClinicalTrials.gov)	April 1, 2020	3/1/2020	Adjunctive Treatment With Vitamin D3 in Patients With Active IBD	Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial	IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency	Dietary Supplement: Vitamin D3;Other: Placebo	Massachusetts General Hospital	NULL	Not yet recruiting	18 Years	N/A	All	100	N/A	NULL
64	NCT04096573 (ClinicalTrials.gov)	April 2020	18/9/2019	Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis	A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: LC51-0255;Drug: Placebo	LG Chem	NULL	Not yet recruiting	18 Years	80 Years	All	240	Phase 2	NULL
65	EUCTR2019-002698-74-BG (EUCTR)	27/03/2020	31/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
66	EUCTR2019-002698-74-SK (EUCTR)	26/03/2020	31/01/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 100 mg/ml Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;India;France;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Japan;China
67	EUCTR2019-002698-74-PL (EUCTR)	24/03/2020	11/02/2020	A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2	A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PF-06480605 Product Code: PF-06480605 INN or Proposed INN: PF-06480605 Other descriptive name: Anti-TL1A	Pfizer Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan
68	EUCTR2019-003849-15-AT (EUCTR)	20/03/2020	06/02/2020	Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis	A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Trade Name: Remsima Product Code: Remsima (CT-P13) INN or Proposed INN: INFLIXIMAB Trade Name: Inflectra Product Code: CT-P13 INN or Proposed INN: INFLIXIMAB	Celltrion, Inc.	NULL	Not Recruiting			Female: yes Male: yes	615	Phase 3	United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany
69	EUCTR2016-000642-62-SE (EUCTR)	18/03/2020	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
70	EUCTR2016-000642-62-FR (EUCTR)	10/03/2020	30/07/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
71	EUCTR2018-001605-93-AT (EUCTR)	09/03/2020	07/11/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
72	EUCTR2017-003703-22-PT (EUCTR)	02/03/2020	18/12/2019	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Portugal;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
73	NCT02277223 (ClinicalTrials.gov)	March 1, 2020	25/10/2014	Curcumin in Pediatric Ulcerative Colitis	Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: Curcumin;Drug: Placebo	Schneider Children's Medical Center, Israel	NULL	Recruiting	6 Years	18 Years	All	60	Phase 3	Israel
74	EUCTR2018-004002-25-ES (EUCTR)	28/02/2020	04/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 2;Phase 3	Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
75	EUCTR2018-003986-33-DK (EUCTR)	28/02/2020	02/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Moldova, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
76	EUCTR2019-003113-34-HU (EUCTR)	25/02/2020	09/01/2020	Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Czech Republic;Hungary;Poland;Russian Federation;Bulgaria;Norway;Germany
77	EUCTR2018-003986-33-GB (EUCTR)	24/02/2020	17/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
78	EUCTR2019-003113-34-DE (EUCTR)	19/02/2020	08/11/2019	Ulcerative colitis	A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA	Mild to moderate ulcerative colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: LYS006 Product Code: LYS006 INN or Proposed INN: not yet defined Other descriptive name: LYS006	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	45	Phase 2	United States;Hungary;Czech Republic;Norway;Germany
79	EUCTR2018-003986-33-ES (EUCTR)	14/02/2020	24/02/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
80	EUCTR2018-003986-33-BG (EUCTR)	11/02/2020	23/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
81	EUCTR2018-003558-26-GB (EUCTR)	11/02/2020	05/11/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
82	EUCTR2019-004090-50-ES (EUCTR)	07/02/2020	11/11/2019	Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis	A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis	Moderate to severe ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ONCOSTELLAE S.L.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	32	Phase 1;Phase 2	Spain
83	NCT04074590 (ClinicalTrials.gov)	February 3, 2020	29/8/2019	Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis	A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis	Colitis, Ulcerative	Drug: LYS006;Drug: Placebo	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	65 Years	All	45	Phase 2	United States;Bulgaria;Czechia;Germany;Hungary;Norway;Poland;Russian Federation
84	EUCTR2018-004002-25-PT (EUCTR)	03/02/2020	06/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
85	NCT04202211 (ClinicalTrials.gov)	February 2020	13/12/2019	FMT for Remission of Active Ulcerative Colitis in Adults	A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Biological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enema	University of British Columbia	Crohn's and Colitis Canada;Vancouver Island Health Authority	Not yet recruiting	18 Years	N/A	All	145	Phase 2	Canada
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
86	NCT03998488 (ClinicalTrials.gov)	January 31, 2020	24/6/2019	Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis	A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Drug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk Powder	Weill Medical College of Cornell University	Crohn's and Colitis Foundation	Recruiting	18 Years	89 Years	All	135	Phase 2	United States
87	EUCTR2018-003986-33-LV (EUCTR)	24/01/2020	01/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	South Africa;Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
88	EUCTR2018-003985-15-AT (EUCTR)	21/01/2020	08/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
89	EUCTR2018-003985-15-FR (EUCTR)	20/01/2020	12/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
90	NCT04223479 (ClinicalTrials.gov)	January 15, 2020	6/1/2020	Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan	Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan	Ulcerative Colitis	Drug: Probiotic Formula Capsule;Drug: Placebos	University of Jordan	NULL	Recruiting	35 Years	65 Years	All	40	Phase 2;Phase 3	Jordan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
91	EUCTR2018-003986-33-FR (EUCTR)	14/01/2020	20/09/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
92	EUCTR2018-003986-33-LT (EUCTR)	31/12/2019	08/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
93	NCT04130919 (ClinicalTrials.gov)	December 20, 2019	16/10/2019	Study to Evaluate the Efficacy and Safety of GS-4875 in Adults With Moderately to Severely Active Ulcerative Colitis	A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: GS-4875;Drug: Placebo	Gilead Sciences	NULL	Recruiting	18 Years	N/A	All	180	Phase 2	United States;Australia;Austria;Canada;France;Germany;Italy;Poland;Switzerland
94	NCT04090411 (ClinicalTrials.gov)	December 19, 2019	12/9/2019	A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis	A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Moderate to Severe Ulcerative Colitis	Drug: 50 mg;Drug: 450 mg;Drug: 150 mg;Other: 0 mg	Pfizer	NULL	Recruiting	18 Years	75 Years	All	240	Phase 2	United States;Australia;Belgium;Bulgaria;France;Hungary;India;Italy;Japan;Poland;Russian Federation;Slovakia;Spain;Thailand;Turkey;Ukraine;Canada;United Kingdom
95	EUCTR2018-005086-39-HR (EUCTR)	16/12/2019	17/01/2020	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
96	EUCTR2018-003278-28-NL (EUCTR)	13/12/2019	22/07/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of
97	EUCTR2018-003558-26-FR (EUCTR)	10/12/2019	08/02/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany
98	EUCTR2017-003703-22-HR (EUCTR)	20/11/2019	13/01/2020	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
99	EUCTR2018-003986-33-HR (EUCTR)	08/11/2019	17/01/2020	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
100	EUCTR2018-003986-33-HU (EUCTR)	07/11/2019	08/11/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
101	EUCTR2016-000642-62-DE (EUCTR)	04/11/2019	18/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
102	EUCTR2018-003349-41-DE (EUCTR)	30/10/2019	19/12/2018	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
103	EUCTR2018-003558-26-DE (EUCTR)	30/10/2019	15/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands
104	EUCTR2018-005086-39-HU (EUCTR)	28/10/2019	08/04/2019	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: BT-11 INN or Proposed INN: to be requested Product Code: BT-11 INN or Proposed INN: to be requested	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
105	EUCTR2018-003278-28-HU (EUCTR)	24/10/2019	25/03/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
106	EUCTR2018-003985-15-ES (EUCTR)	21/10/2019	21/10/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
107	EUCTR2018-004002-25-BE (EUCTR)	21/10/2019	10/09/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
108	EUCTR2018-004002-25-FR (EUCTR)	15/10/2019	14/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 2;Phase 3	United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden
109	EUCTR2018-004002-25-SE (EUCTR)	15/10/2019	03/07/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: GUSELKUMAB Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
110	EUCTR2018-003985-15-PT (EUCTR)	14/10/2019	10/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;United States;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
111	EUCTR2018-003986-33-BE (EUCTR)	14/10/2019	15/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany
112	EUCTR2018-004002-25-GB (EUCTR)	09/10/2019	20/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab Product Name: guselkumab Product Code: CNTO1959 INN or Proposed INN: Guselkumab	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	950	Phase 2;Phase 3	United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden
113	EUCTR2018-001605-93-BG (EUCTR)	09/10/2019	20/09/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
114	EUCTR2018-005086-39-PL (EUCTR)	07/10/2019	06/05/2019	A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors. MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: BT-11 500 mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11 Product Name: BT-11 1000mg Product Code: BT-11 INN or Proposed INN: to be requested Other descriptive name: BT-11	Landos Biopharma Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	195	Phase 2	United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina
115	EUCTR2017-004230-28-CZ (EUCTR)	04/10/2019	11/07/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
116	EUCTR2018-003986-33-NL (EUCTR)	03/10/2019	22/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
117	EUCTR2018-004002-25-HU (EUCTR)	01/10/2019	13/08/2019	A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1000	Phase 2;Phase 3	Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden
118	NCT04006977 (ClinicalTrials.gov)	October 2019	1/7/2019	Multistrain Probiotics Reduces UC Depression and Anxiety Scores	Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis	Ulcerative Colitis	Dietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: Placebo	Xijing Hospital of Digestive Diseases	MENDES SA	Not yet recruiting	18 Years	65 Years	All	60	N/A	China
119	EUCTR2018-003985-15-DK (EUCTR)	27/09/2019	24/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
120	EUCTR2018-003985-15-BG (EUCTR)	27/09/2019	12/08/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
121	NCT04033445 (ClinicalTrials.gov)	September 26, 2019	24/7/2019	A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Placebo;Drug: Guselkumab	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	N/A	All	950	Phase 2;Phase 3	United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Serbia;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania
122	EUCTR2018-003278-28-CZ (EUCTR)	25/09/2019	15/04/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
123	EUCTR2018-004694-27-DE (EUCTR)	24/09/2019	24/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
124	EUCTR2018-001605-93-BE (EUCTR)	23/09/2019	07/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2b Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of
125	NCT03847467 (ClinicalTrials.gov)	September 20, 2019	12/2/2019	Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy	Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Drug: 2'-Fucosyllactose;Other: Placebo	Children's Hospital Medical Center, Cincinnati	Broad Institute;University of Cincinnati;Connecticut Children's Medical Center	Recruiting	11 Years	25 Years	All	216	Phase 1;Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
126	EUCTR2018-003985-15-NL (EUCTR)	18/09/2019	09/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
127	EUCTR2018-001605-93-FR (EUCTR)	13/09/2019	25/06/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
128	NCT04176588 (ClinicalTrials.gov)	September 10, 2019	22/11/2019	A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis	Drug: Etrasimod;Drug: Placebo	Everstar Therapeutics Limited	NULL	Recruiting	18 Years	75 Years	All	333	Phase 3	China
129	EUCTR2018-002136-24-FR (EUCTR)	10/09/2019	19/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
130	EUCTR2017-004230-28-HU (EUCTR)	06/09/2019	08/07/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
131	EUCTR2016-000642-62-HR (EUCTR)	30/08/2019	20/01/2020	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Belarus;United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
132	EUCTR2018-003558-26-BE (EUCTR)	29/08/2019	27/05/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
133	EUCTR2018-003985-15-LT (EUCTR)	27/08/2019	10/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
134	EUCTR2018-003985-15-EE (EUCTR)	26/08/2019	15/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
135	EUCTR2018-004491-35-PL (EUCTR)	19/08/2019	03/07/2019	A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis	A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Incyte Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	206	Phase 2	United States;Czech Republic;Poland;Romania;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
136	NCT03861143 (ClinicalTrials.gov)	August 14, 2019	27/2/2019	Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: Placebo	Landos Biopharma Inc.	NULL	Active, not recruiting	18 Years	65 Years	All	198	Phase 2	United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia
137	EUCTR2018-003985-15-HR (EUCTR)	14/08/2019	24/12/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey
138	EUCTR2018-004694-27-CZ (EUCTR)	13/08/2019	19/07/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Hungary;Czech Republic;Poland;Belgium;Australia;Russian Federation;Germany;Japan;Italy;United Kingdom;Korea, Republic of
139	NCT03977480 (ClinicalTrials.gov)	August 13, 2019	27/4/2019	Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis	A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Hemay007;Drug: Placebo	Tianjin Hemay Pharmaceutical Co.,Ltd	NULL	Recruiting	18 Years	70 Years	All	288	Phase 2	China
140	NCT03869905 (ClinicalTrials.gov)	August 8, 2019	8/3/2019	Aquamin® as an Adjuvant Intervention for Ulcerative Colitis	Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission	Ulcerative Colitis	Drug: Aquamin®;Drug: Placebo first then Aquamin®	James Varani	NULL	Recruiting	18 Years	80 Years	All	40	Phase 2	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
141	EUCTR2018-001605-93-ES (EUCTR)	07/08/2019	09/08/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	Allergan Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	900	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan
142	EUCTR2018-003278-28-PL (EUCTR)	03/08/2019	11/06/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of
143	ChiCTR1900024086	2019-08-01	2019-06-24	Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials	Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials	Ulcerative Colitis	intervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo;	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	NULL	Pending	18	75	Both	intervention period:10;control period:10;	N/A	China
144	NCT04029649 (ClinicalTrials.gov)	August 2019	17/7/2019	Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis	The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial	Ulcerative Colitis	Drug: Beta-1,3/1,6-D-Glucan;Drug: Placebo	Fakultas Kedokteran Universitas Indonesia	NULL	Not yet recruiting	18 Years	N/A	All	204	Phase 2;Phase 3	Indonesia
145	NCT03948919 (ClinicalTrials.gov)	July 31, 2019	10/5/2019	Low Sulfur Fecal Transplant for Ulcerative Colitis	Low Sulfur Fecal Transplant for Ulcerative Colitis	Ulcerative Colitis	Drug: Fecal microbiota;Other: Placebo	University of Minnesota	NULL	Recruiting	18 Years	89 Years	All	20	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
146	EUCTR2016-004676-22-BG (EUCTR)	30/07/2019	14/05/2019	Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065.	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
147	EUCTR2016-000642-62-PT (EUCTR)	29/07/2019	16/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;United States;Belarus;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Croatia;Germany;Norway;Japan;Sweden
148	EUCTR2018-003985-15-HU (EUCTR)	29/07/2019	16/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
149	EUCTR2016-000642-62-GB (EUCTR)	26/07/2019	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
150	EUCTR2018-004694-27-GB (EUCTR)	23/07/2019	30/04/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
151	EUCTR2018-003349-41-FR (EUCTR)	11/07/2019	27/05/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
152	EUCTR2018-003985-15-LV (EUCTR)	05/07/2019	02/07/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan
153	EUCTR2018-001605-93-GB (EUCTR)	01/07/2019	04/04/2019	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139 Trade Name: Entyvio INN or Proposed INN: Entyvio Other descriptive name: VEDOLIZUMAB Product Name: Brazikumab Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human INN or Proposed INN: BRAZIKUMAB Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	375	Phase 2	United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan
154	EUCTR2017-004230-28-GR (EUCTR)	01/07/2019	03/05/2019	BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]		Boehringer Ingelheim International GmbH	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
155	EUCTR2018-003986-33-SK (EUCTR)	01/07/2019	02/05/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
156	EUCTR2018-004694-27-PL (EUCTR)	30/06/2019	15/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of
157	EUCTR2018-004694-27-HU (EUCTR)	25/06/2019	06/05/2019	Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165 Other descriptive name: BMS986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	United States;Spain;Russian Federation;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Germany;Japan;Korea, Republic of
158	EUCTR2018-002136-24-DE (EUCTR)	25/06/2019	27/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
159	EUCTR2016-004677-40-BG (EUCTR)	25/06/2019	18/04/2019	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
160	NCT03923478 (ClinicalTrials.gov)	June 24, 2019	15/4/2019	ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment	Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate	Drug: ABI-M201;Drug: Placebo	Assembly Biosciences	NULL	Recruiting	18 Years	70 Years	All	44	Phase 1	United States;Canada
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
161	EUCTR2018-003985-15-SK (EUCTR)	21/06/2019	16/04/2019	A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine	Arena Pharmaceuticals Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	372	Phase 3	Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand
162	EUCTR2016-000642-62-GR (EUCTR)	21/06/2019	25/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
163	EUCTR2016-000642-62-IE (EUCTR)	18/06/2019	26/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
164	NCT03483246 (ClinicalTrials.gov)	June 18, 2019	26/2/2018	Impact of Fecal Microbiota Transplantation in Ulcerative Colitis	Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial	Ulcerative Colitis	Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation Placebo	Assistance Publique - Hôpitaux de Paris	CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France	Recruiting	18 Years	75 Years	All	150	Phase 3	France
165	EUCTR2017-004230-28-DK (EUCTR)	14/06/2019	24/03/2019	BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Denmark A/S	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
166	NCT03945188 (ClinicalTrials.gov)	June 13, 2019	8/5/2019	Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Etrasimod;Drug: Placebo	Arena Pharmaceuticals	NULL	Recruiting	16 Years	80 Years	All	372	Phase 3	United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom
167	EUCTR2016-000642-62-NL (EUCTR)	13/06/2019	11/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
168	EUCTR2018-003558-26-SI (EUCTR)	12/06/2019	07/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany
169	EUCTR2018-002136-24-BG (EUCTR)	12/06/2019	18/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
170	NCT03760003 (ClinicalTrials.gov)	June 11, 2019	29/11/2018	Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis	A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment	Ulcerative Colitis	Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo	Abivax S.A.	NULL	Recruiting	18 Years	75 Years	All	232	Phase 2	United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
171	NCT03915769 (ClinicalTrials.gov)	June 3, 2019	12/4/2019	To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis	A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Ozanimod;Other: Placebo	Celgene	NULL	Recruiting	18 Years	75 Years	All	195	Phase 3	Japan
172	EUCTR2013-004279-11-FR (EUCTR)	03/06/2019	09/04/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria
173	NCT03941418 (ClinicalTrials.gov)	June 1, 2019	5/5/2019	Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease	Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease	Ulcerative Colitis;Crohn Disease	Dietary Supplement: Boulardii;Dietary Supplement: Placebo	University Clinic Dr Dragisa Misovic-Dedinje	University Clinic Zvezdara	Not yet recruiting	18 Years	80 Years	All	150	N/A	NULL
174	EUCTR2018-003349-41-BG (EUCTR)	29/05/2019	27/02/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
175	EUCTR2018-000930-37-ES (EUCTR)	27/05/2019	22/01/2019	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
176	EUCTR2018-002136-24-ES (EUCTR)	23/05/2019	11/04/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany
177	EUCTR2018-003558-26-SK (EUCTR)	23/05/2019	20/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;United States;Belarus;Serbia;Slovakia;Hungary;Canada;Belgium;Poland;Germany
178	EUCTR2018-003558-26-HU (EUCTR)	21/05/2019	25/03/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	232	Phase 2	United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany
179	EUCTR2018-003558-26-PL (EUCTR)	20/05/2019	12/04/2019	Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.	A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment.	Moderate to Severe Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464 Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	244	Phase 2	Serbia;United States;Belarus;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany
180	EUCTR2016-004676-22-SI (EUCTR)	20/05/2019	06/02/2019	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Bulgaria;Germany;New Zealand;Japan;Sweden;Romania;Croatia;United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
181	EUCTR2016-004677-40-SI (EUCTR)	20/05/2019	06/02/2019	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
182	NCT03943550 (ClinicalTrials.gov)	May 14, 2019	7/5/2019	Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)	A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis	Ulcerative Colitis	Drug: RO7049665;Drug: Placebo	Hoffmann-La Roche	NULL	Recruiting	18 Years	70 Years	All	50	Phase 1	United States;Georgia;Hungary;Moldova, Republic of;Ukraine
183	EUCTR2018-000930-37-FR (EUCTR)	07/05/2019	07/12/2018	A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	60	Phase 2	United States;France;Canada;Spain;Netherlands;Germany;Italy;United Kingdom
184	EUCTR2018-003278-28-FR (EUCTR)	07/05/2019	09/05/2019	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
185	NCT03893565 (ClinicalTrials.gov)	May 6, 2019	26/3/2019	Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis	A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis	Colitis, Ulcerative	Drug: GSK2831781 IV infusion;Drug: GSK2831781 SC injection;Drug: Placebo IV infusion;Drug: Placebo SC injection	GlaxoSmithKline	NULL	Recruiting	18 Years	N/A	All	242	Phase 2	United States;Belgium;Bulgaria;Canada;Czechia;Estonia;France;India;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
186	NCT03934216 (ClinicalTrials.gov)	May 3, 2019	30/4/2019	Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis (UC)	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: BMS-986165;Drug: Placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	80 Years	All	120	Phase 2	United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom
187	NCT03843385 (ClinicalTrials.gov)	May 2019	14/2/2019	Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis	Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis	Ulcerative Colitis;Inflammatory Bowel Diseases	Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo	Jena University Hospital	German Federal Ministry of Education and Research	Not yet recruiting	18 Years	75 Years	All	174	Phase 2;Phase 3	NULL
188	EUCTR2018-003278-28-GB (EUCTR)	29/04/2019	14/12/2018	Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.	A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GSK2831781 INN or Proposed INN: Not Assigned Other descriptive name: GSK2831781	GlaxoSmithKline Research & Development Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	320	Phase 2	United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of
189	EUCTR2017-003703-22-PL (EUCTR)	25/04/2019	26/04/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
190	NCT03860896 (ClinicalTrials.gov)	April 24, 2019	14/2/2019	GB004 in Adult Subjects With Active Ulcerative Colitis	A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis	Ulcerative Colitis	Drug: GB004;Drug: Placebo	GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.	NULL	Completed	18 Years	74 Years	All	34	Phase 1	United States;Georgia;Moldova, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
191	NCT03800420 (ClinicalTrials.gov)	April 22, 2019	7/1/2019	Efficacy and Safety of BBT-401-1S in Ulcerative Colitis	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis	Ulcerative Colitis	Drug: Active group;Drug: Placebo group	Bridge Biotherapeutics, Inc.	KCRN Research, LLC	Terminated	18 Years	N/A	All	16	Phase 2	United States
192	NCT03675477 (ClinicalTrials.gov)	April 13, 2019	16/9/2018	A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.	A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.	Ulcerative Colitis	Drug: SHR0302;Drug: Placebos	Reistone Biopharma Company Limited	NULL	Active, not recruiting	18 Years	75 Years	All	164	Phase 2	United States;China;Poland;Puerto Rico;Ukraine
193	EUCTR2013-004277-27-HU (EUCTR)	11/04/2019	25/02/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand
194	EUCTR2018-002136-24-PL (EUCTR)	04/04/2019	18/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
195	EUCTR2018-002136-24-GR (EUCTR)	03/04/2019	18/02/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Not Recruiting			Female: yes Male: yes	880	Phase 2;Phase 3	Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
196	NCT03794765 (ClinicalTrials.gov)	April 1, 2019	4/1/2019	Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis	Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial	Ulcerative Colitis;Inflammatory Bowel Diseases;Acute Severe Colitis	Drug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusion	Postgraduate Institute of Medical Education and Research	NULL	Completed	13 Years	N/A	All	50	Phase 2	India
197	NCT04000139 (ClinicalTrials.gov)	April 1, 2019	24/6/2019	Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative Colitis	A Multi-center, Multi-national, Randomized, Double-blind, Placebo Controlled, Parallel Group, Phase IIa Study to Evaluate the Efficacy, Safety and Tolerability of an Anthocyanin-rich Extract (ACRE) in Patients With Ulcerative Colitis	Ulcerative Colitis	Drug: Standardized anthocyanin-rich extract;Drug: Placebo	University of Zurich	Swiss National Science Foundation;The Broad Foundation	Recruiting	18 Years	N/A	All	120	Phase 2	Switzerland
198	NCT04224857 (ClinicalTrials.gov)	April 1, 2019	23/5/2019	SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101	A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101	Ulcerative Colitis	Drug: AMT -101;Drug: Placebos	Applied Molecular Transport	NULL	Completed	18 Years	N/A	All	52	Phase 1	Georgia;Germany;Moldova, Republic of;Ukraine
199	EUCTR2018-003349-41-GB (EUCTR)	28/03/2019	21/12/2018	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	380	Phase 2	Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany
200	EUCTR2016-000642-62-LT (EUCTR)	19/03/2019	15/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
201	EUCTR2018-002136-24-PT (EUCTR)	18/03/2019	02/01/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
202	EUCTR2013-004277-27-CZ (EUCTR)	18/03/2019	29/03/2019	A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors	PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II	Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: Etrolizumab Other descriptive name: ETROLIZUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Humira INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 3	United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand
203	NCT03768219 (ClinicalTrials.gov)	March 18, 2019	30/11/2018	Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis	Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis	Psoriasis;Ulcerative Colitis	Biological: APVO210;Biological: Placebo	Aptevo Therapeutics	NULL	Active, not recruiting	18 Years	65 Years	All	144	Phase 1	Australia
204	EUCTR2018-003364-31-PL (EUCTR)	15/03/2019	23/01/2019	A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.	A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis.	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHR0302 INN or Proposed INN: Pending	Reistone Biopharma Company Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	152	Phase 2	United States;Poland;Ukraine;China
205	EUCTR2016-000642-62-PL (EUCTR)	14/03/2019	12/06/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
206	NCT03758443 (ClinicalTrials.gov)	March 11, 2019	19/11/2018	Efficacy & Safety of TD-1473 in Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C;Drug: Placebo	Theravance Biopharma	NULL	Recruiting	18 Years	N/A	All	880	Phase 2;Phase 3	United States;Australia;Bulgaria;Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine
207	EUCTR2018-003349-41-PL (EUCTR)	27/02/2019	15/01/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine	Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany
208	EUCTR2018-002136-24-SK (EUCTR)	19/02/2019	28/12/2018	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
209	EUCTR2018-003349-41-HU (EUCTR)	19/02/2019	08/01/2019	Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis	Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Sublimity Therapeutics (Hold Co) Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Serbia;United States;Belarus;Spain;Ukraine;Ireland;Turkey;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany
210	EUCTR2018-002136-24-HU (EUCTR)	18/02/2019	29/03/2019	A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis	A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis	Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060 Product Name: TD-1473 Product Code: TD-1473 INN or Proposed INN: Not assigned Other descriptive name: THRX-139060	Theravance Biopharma Ireland Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	880	Phase 2;Phase 3	Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
211	EUCTR2017-003229-14-HR (EUCTR)	08/02/2019	16/05/2019	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
212	EUCTR2017-003238-96-HR (EUCTR)	08/02/2019	17/05/2019	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
213	NCT03832400 (ClinicalTrials.gov)	February 4, 2019	21/11/2018	Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC)	A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative Colitis	Ulcerative Colitis	Biological: MET-2;Drug: Placebo oral capsule	NuBiyota	NULL	Active, not recruiting	18 Years	N/A	All	30	Phase 1	Canada
214	EUCTR2016-004676-22-HR (EUCTR)	01/02/2019	16/05/2019	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
215	EUCTR2016-004677-40-HR (EUCTR)	31/01/2019	16/05/2019	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
216	EUCTR2016-000642-62-SK (EUCTR)	28/01/2019	28/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
217	NCT03844932 (ClinicalTrials.gov)	January 24, 2019	31/1/2019	A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: ST-0529	Sublimity Therapeutics Holdco Limited	Dr. Falk Pharma GmbH	Recruiting	18 Years	75 Years	All	280	Phase 2	United States;Belarus;Bulgaria;Canada;France;Germany;Hungary;Ireland;Israel;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
218	EUCTR2016-004676-22-DE (EUCTR)	22/01/2019	15/06/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
219	EUCTR2016-000642-62-ES (EUCTR)	17/01/2019	24/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
220	EUCTR2016-000642-62-CZ (EUCTR)	14/01/2019	14/11/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
221	EUCTR2016-004676-22-BE (EUCTR)	14/01/2019	04/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
222	EUCTR2016-000642-62-AT (EUCTR)	02/01/2019	30/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	522	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
223	EUCTR2016-004676-22-GB (EUCTR)	20/12/2018	03/07/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
224	EUCTR2016-000642-62-HU (EUCTR)	19/12/2018	08/01/2019	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
225	NCT03759041 (ClinicalTrials.gov)	December 19, 2018	27/11/2018	A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis	ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: Vancomycin Pre-Treatment;Drug: Placebo for Vancomycin Pre-Treatment;Drug: SER-287;Drug: Placebo for SER-287	Seres Therapeutics, Inc.	NULL	Recruiting	18 Years	80 Years	All	201	Phase 2	United States;Canada
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
226	JPRN-JapicCTI-184131	18/12/2018	28/09/2018	A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675]	Ulcerative Colitis	Intervention name : ABT-494 INN of the intervention : upadacitinib Dosage And administration of the intervention : Will be orally administered Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Will be orally administered	AbbVie GK	NULL	recruiting	16	75	BOTH	45	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa, -
227	EUCTR2016-000642-62-LV (EUCTR)	13/12/2018	15/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	462	Phase 3	Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan
228	EUCTR2017-002350-36-GB (EUCTR)	10/12/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
229	NCT03574948 (ClinicalTrials.gov)	December 6, 2018	22/6/2018	5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores	Multicentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue Scores	Crohn Disease;Ulcerative Colitis;Fatigue;Remission	Drug: 5-HTP;Drug: Placebo oral capsule	University Hospital, Ghent	NULL	Recruiting	18 Years	60 Years	All	180	Phase 2	Belgium
230	EUCTR2016-004677-40-DE (EUCTR)	04/12/2018	26/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjectswith Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled InductionStudy to Evaluate the Efficacy and Safety of Risankizumab in Subjects withModerately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
231	NCT03716388 (ClinicalTrials.gov)	December 1, 2018	21/10/2018	Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC	Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study	Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate	Biological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granules	Dayanand Medical College and Hospital	Colitis & Crohn's Foundation (India)	Recruiting	18 Years	75 Years	All	20	Phase 3	India
232	NCT02201758 (ClinicalTrials.gov)	December 2018	18/7/2014	Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment	Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment.	Ulcerative Colitis	Dietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: Placebo	University of Saskatchewan	Royal University Hospital Foundation	Unknown status	18 Years	N/A	All	56	Phase 2	Canada
233	EUCTR2016-004677-40-BE (EUCTR)	29/11/2018	04/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey
234	EUCTR2017-003229-14-DK (EUCTR)	20/11/2018	11/10/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly Cork Limited	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
235	NCT03662542 (ClinicalTrials.gov)	November 20, 2018	6/9/2018	A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis	Colitis, Ulcerative	Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo	Janssen Research & Development, LLC	NULL	Recruiting	18 Years	65 Years	All	210	Phase 2	United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
236	EUCTR2017-003238-96-DK (EUCTR)	20/11/2018	09/10/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
237	EUCTR2016-004676-22-DK (EUCTR)	15/11/2018	02/05/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
238	EUCTR2016-000642-62-FI (EUCTR)	13/11/2018	16/10/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis	M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	462	Phase 3	Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden
239	NCT03653026 (ClinicalTrials.gov)	November 12, 2018	28/8/2018	A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: Upadacitinib (ABT-494);Drug: Placebo	AbbVie	NULL	Active, not recruiting	16 Years	75 Years	All	523	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Egypt;Romania;Sweden
240	NCT03558152 (ClinicalTrials.gov)	October 26, 2018	1/6/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)	A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis	Ulcerative Colitis	Drug: UTTR1147A;Drug: UTTR1147A Placebo;Drug: Vedolizumab;Drug: Vedolizumab Placebo	Genentech, Inc.	NULL	Recruiting	18 Years	80 Years	All	270	Phase 2	United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
241	EUCTR2016-004677-40-GR (EUCTR)	26/10/2018	04/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
242	EUCTR2016-004676-22-GR (EUCTR)	26/10/2018	04/06/2018	A Study of Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
243	EUCTR2017-003229-14-GB (EUCTR)	24/10/2018	04/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
244	EUCTR2017-003238-96-AT (EUCTR)	24/10/2018	22/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
245	EUCTR2017-003229-14-AT (EUCTR)	24/10/2018	22/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
246	EUCTR2017-003238-96-GB (EUCTR)	22/10/2018	04/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
247	EUCTR2017-000402-38-SE (EUCTR)	19/10/2018	25/05/2018	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
248	NCT03524092 (ClinicalTrials.gov)	October 19, 2018	10/5/2018	A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)	Ulcerative Colitis	Drug: Mirikizumab;Drug: Placebo	Eli Lilly and Company	NULL	Recruiting	18 Years	80 Years	All	1044	Phase 3	United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
249	EUCTR2017-003229-14-DE (EUCTR)	15/10/2018	30/04/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania
250	EUCTR2017-003238-96-DE (EUCTR)	15/10/2018	03/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
251	EUCTR2017-002350-36-GR (EUCTR)	03/10/2018	10/09/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
252	EUCTR2016-004676-22-SE (EUCTR)	02/10/2018	16/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
253	EUCTR2016-004677-40-SE (EUCTR)	02/10/2018	16/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
254	EUCTR2017-003238-96-HU (EUCTR)	27/09/2018	13/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
255	EUCTR2017-002350-36-DE (EUCTR)	27/09/2018	13/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
256	EUCTR2017-003229-14-HU (EUCTR)	27/09/2018	15/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
257	EUCTR2016-004677-40-NL (EUCTR)	26/09/2018	24/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
258	EUCTR2016-004676-22-NL (EUCTR)	26/09/2018	02/05/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands
259	NCT03627052 (ClinicalTrials.gov)	September 20, 2018	8/8/2018	A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis	A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis	Moderate to Severe Ulcerative Colitis	Drug: Itacitinib;Drug: Placebo	Incyte Corporation	NULL	Withdrawn	18 Years	74 Years	All	0	Phase 2	United States
260	EUCTR2017-003229-14-SK (EUCTR)	06/09/2018	06/07/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
261	EUCTR2017-003238-96-SK (EUCTR)	04/09/2018	20/07/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
262	EUCTR2017-004230-28-NL (EUCTR)	30/08/2018	15/03/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim bv	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of
263	EUCTR2016-004676-22-LV (EUCTR)	30/08/2018	29/08/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Korea, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
264	EUCTR2017-003238-96-LV (EUCTR)	30/08/2018	21/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
265	EUCTR2017-002350-36-NL (EUCTR)	28/08/2018	24/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	330	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
266	NCT03398135 (ClinicalTrials.gov)	August 28, 2018	8/1/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: risankizumab;Drug: placebo for risankizumab	AbbVie	NULL	Enrolling by invitation	16 Years	80 Years	All	760	Phase 3	United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Hungary
267	JPRN-JapicCTI-184008	28/8/2018	21/06/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066]	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066]	Ulcerative Colitis (UC)	Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	AbbVie GK	NULL	recruiting	16	80	BOTH	70	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
268	EUCTR2017-002350-36-IE (EUCTR)	28/08/2018	16/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
269	EUCTR2017-000573-37-EE (EUCTR)	27/08/2018	11/06/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
270	EUCTR2016-004677-40-LT (EUCTR)	23/08/2018	13/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
271	EUCTR2016-004676-22-LT (EUCTR)	23/08/2018	26/06/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
272	EUCTR2017-002350-36-BG (EUCTR)	22/08/2018	28/05/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany
273	EUCTR2017-003229-14-CZ (EUCTR)	16/08/2018	30/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India
274	EUCTR2017-003238-96-CZ (EUCTR)	16/08/2018	30/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
275	EUCTR2016-004676-22-SK (EUCTR)	14/08/2018	05/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
276	EUCTR2016-004677-40-SK (EUCTR)	14/08/2018	05/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden
277	NCT03616821 (ClinicalTrials.gov)	August 7, 2018	1/8/2018	An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]	A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis	Colitis;Ulcerative;IBD	Drug: Brazikumab;Drug: Vedolizumab;Drug: Placebo	Allergan	NULL	Recruiting	18 Years	80 Years	All	375	Phase 2	United States;Canada;Puerto Rico
278	EUCTR2017-003229-14-LV (EUCTR)	03/08/2018	21/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
279	EUCTR2016-004677-40-LV (EUCTR)	03/08/2018	27/07/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
280	EUCTR2017-003238-96-ES (EUCTR)	01/08/2018	04/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
281	EUCTR2017-003238-96-BE (EUCTR)	27/07/2018	07/06/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
282	EUCTR2017-003229-14-BE (EUCTR)	27/07/2018	08/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
283	EUCTR2017-002108-28-DE (EUCTR)	25/07/2018	27/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: PF-06687234 Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	76	Phase 2	United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
284	EUCTR2017-000402-38-BE (EUCTR)	25/07/2018	30/05/2018	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden
285	EUCTR2017-003229-14-ES (EUCTR)	24/07/2018	04/06/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
286	EUCTR2017-003238-96-NL (EUCTR)	24/07/2018	14/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan
287	EUCTR2017-003703-22-NL (EUCTR)	24/07/2018	05/03/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2	Serbia;United States;Czech Republic;Poland;Belgium;Spain;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom
288	EUCTR2015-000319-41-GR (EUCTR)	23/07/2018	18/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
289	EUCTR2016-004676-22-PT (EUCTR)	16/07/2018	02/07/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
290	EUCTR2016-004677-40-PT (EUCTR)	16/07/2018	01/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
291	EUCTR2017-000402-38-ES (EUCTR)	13/07/2018	25/07/2018	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis	To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Sweden
292	EUCTR2015-000319-41-ES (EUCTR)	12/07/2018	21/05/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
293	NCT03860571 (ClinicalTrials.gov)	July 6, 2018	3/2/2019	Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers	A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers	Ulcerative Colitis;Crohn Disease	Drug: BT-11 Placebo;Drug: BT-11 Active	Landos Biopharma Inc.	NULL	Completed	18 Years	65 Years	All	70	Phase 1	United States
294	EUCTR2017-003229-14-LT (EUCTR)	05/07/2018	31/05/2018	AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1160	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
295	EUCTR2017-003238-96-LT (EUCTR)	05/07/2018	31/05/2018	A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS	A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2	Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB Product Name: mirikizumab Product Code: LY3074828 INN or Proposed INN: MIRIKIZUMAB Other descriptive name: MIRIKIZUMAB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1044	Phase 3	United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
296	NCT03773952 (ClinicalTrials.gov)	July 1, 2018	30/11/2018	Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients	A Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative Colitis	Ulcerative Colitis	Drug: PBF-677;Drug: Placebo oral capsule	Palobiofarma SL	Qualitecfarma	Recruiting	18 Years	75 Years	All	50	Phase 2	Spain
297	EUCTR2016-004677-40-DK (EUCTR)	28/06/2018	12/06/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
298	EUCTR2016-004677-40-AT (EUCTR)	25/06/2018	06/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1547	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
299	EUCTR2016-004676-22-AT (EUCTR)	25/06/2018	06/04/2018	A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	942	Phase 3	United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
300	EUCTR2015-000319-41-LV (EUCTR)	22/06/2018	13/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
301	EUCTR2016-004677-40-ES (EUCTR)	21/06/2018	17/04/2018	A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	720	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
302	EUCTR2017-002350-36-HU (EUCTR)	14/06/2018	19/04/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	270	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
303	EUCTR2017-000572-28-BE (EUCTR)	08/06/2018	14/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
304	NCT03531892 (ClinicalTrials.gov)	June 6, 2018	9/5/2018	A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis	Phase III Study of AJM300 in Patients With Active Ulcerative Colitis	Colitis, Ulcerative	Drug: AJM300;Drug: Placebo	EA Pharma Co., Ltd.	Kissei Pharmaceutical Co., Ltd.	Recruiting	16 Years	74 Years	All	198	Phase 3	Japan
305	EUCTR2016-004676-22-ES (EUCTR)	05/06/2018	13/04/2018	NA	A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065	Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Risankizumab Product Code: ABBV-006 INN or Proposed INN: RISANKIZUMAB Product Name: Risankizumab Product Code: ABBV-066 INN or Proposed INN: RISANKIZUMAB	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	760	Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
306	EUCTR2017-004230-28-DE (EUCTR)	04/06/2018	31/01/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: SPESOLIMAB Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Pharma GmbH & Co. KG	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
307	JPRN-JapicCTI-183997	29/5/2018	12/06/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]	Ulcerative Colitis (UC)	Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	AbbVie GK	NULL	recruiting	16	80	BOTH	65		Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
308	EUCTR2017-003228-54-ES (EUCTR)	28/05/2018	09/04/2018	A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.	A Phase IIa (proof of concept), randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.	Inflammatory Bowel disease, mild to moderate Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: PBF-677 INN or Proposed INN: PBF-677	PaloBiofarma S.L.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Spain
309	EUCTR2015-000319-41-AT (EUCTR)	25/05/2018	17/04/2018	The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis	ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: 0.25mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC103 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride	Celgene International II Sàrl (CIS II)	NULL	Not Recruiting			Female: yes Male: yes	900	Phase 3	United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand
310	EUCTR2017-000402-38-NL (EUCTR)	24/05/2018	13/11/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;New Zealand;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
311	EUCTR2017-004230-28-IT (EUCTR)	22/05/2018	05/11/2020	BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - -	Moderate-to-severely active ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: - Product Code: [BI 655130] Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	BOEHRINGER-INGELHEIM ITALIA S.P.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of
312	NCT03565939 (ClinicalTrials.gov)	May 4, 2018	22/5/2018	Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)	Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)	Ulcerative Colitis Chronic Moderate	Biological: Trichuris suis ova;Biological: Placebo	ParaTech A/S	NULL	Recruiting	18 Years	75 Years	All	120	Phase 2	Denmark
313	EUCTR2017-003703-22-GB (EUCTR)	03/05/2018	31/01/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium dihydrate Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium dihydrate Other descriptive name: IM90838	Immunic AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina
314	NCT03594708 (ClinicalTrials.gov)	April 30, 2018	19/1/2018	Immunonutrition in Ulcerative Colitis	Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients	Ulcerative Colitis	Dietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplement	Baptist Memorial Health Care Corporation	NULL	Unknown status	18 Years	N/A	All	30	N/A	United States
315	EUCTR2017-003703-22-ES (EUCTR)	29/04/2018	20/02/2018	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)	A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Immunic AG	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2	Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
316	EUCTR2017-000573-37-HR (EUCTR)	23/04/2018	07/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
317	EUCTR2017-000599-27-HR (EUCTR)	20/04/2018	07/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
318	EUCTR2016-003708-29-BG (EUCTR)	20/04/2018	17/01/2018	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
319	EUCTR2017-002350-36-ES (EUCTR)	15/04/2018	06/06/2018	A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.	A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: UTTR1147A/RO7021610 (Active) INN or Proposed INN: n.a. Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Trade Name: Entyvio 300mg Product Code: RO7246311 INN or Proposed INN: Vedolizumab Other descriptive name: VEDOLIZUMAB	Roche Farma, S.A por delegación de Genentech, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	330	Phase 2	Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands
320	EUCTR2017-004230-28-GB (EUCTR)	13/04/2018	01/02/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: Spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim Limited	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
321	EUCTR2017-002108-28-ES (EUCTR)	12/04/2018	20/04/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Dekavil Product Code: PF-06687234 INN or Proposed INN: Dekavil Other descriptive name: F8IL10	Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Not Recruiting			Female: yes Male: yes	98	Phase 2	United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of
322	EUCTR2017-000599-27-DE (EUCTR)	10/04/2018	24/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
323	EUCTR2017-000573-37-DE (EUCTR)	10/04/2018	24/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
324	EUCTR2017-004230-28-ES (EUCTR)	09/04/2018	08/02/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim España, S.A.	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of
325	NCT03290781 (ClinicalTrials.gov)	April 4, 2018	6/9/2017	An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)	Ulcerative Colitis	Drug: Ontamalimab;Other: Placebo	Shire	NULL	Active, not recruiting	16 Years	81 Years	All	366	Phase 3	United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
326	EUCTR2017-002108-28-BE (EUCTR)	30/03/2018	22/03/2018	A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Pfizer Inc, 235 East 42nd Street, New York, New York 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	76	Phase 2	Serbia;United States;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of
327	EUCTR2016-000641-31-BE (EUCTR)	29/03/2018	31/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
328	NCT03482635 (ClinicalTrials.gov)	March 27, 2018	15/3/2018	BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy	Colitis, Ulcerative	Drug: Spesolimab;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	18 Years	75 Years	All	98	Phase 2;Phase 3	United States;Austria;Belgium;Canada;Germany;Greece;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Australia;Czechia;Denmark;Hungary;Norway
329	NCT03597971 (ClinicalTrials.gov)	March 20, 2018	3/5/2018	HMPL004-6599 Phase I Dose-escalating Study	A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers	Ulcerative Colitis;Crohn Disease	Drug: HMPL004-6599;Drug: Placebo	Nutrition Science Partners Limited	Hutchison Medipharma Limited;Nestlé	Terminated	18 Years	45 Years	Male	32	Phase 1	Australia
330	NCT03482648 (ClinicalTrials.gov)	March 20, 2018	17/3/2018	First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers	A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects	Ulcerative Colitis	Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo	Bridge Biotherapeutics, Inc.	KCRN Research, LLC	Completed	19 Years	55 Years	All	80	Phase 1	United States
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
331	EUCTR2017-000573-37-NL (EUCTR)	15/03/2018	02/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
332	NCT03518086 (ClinicalTrials.gov)	March 15, 2018	4/5/2018	An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)	A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)	Ulcerative Colitis	Drug: Mirikizumab;Drug: Placebo	Eli Lilly and Company	NULL	Recruiting	18 Years	80 Years	All	1160	Phase 3	United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil
333	NCT03341962 (ClinicalTrials.gov)	March 15, 2018	8/11/2017	Phase 2 Dose-finding IMU-838 for Ulcerative Colitis	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis	Ulcerative Colitis	Drug: IMU-838;Drug: Placebo	Immunic AG	NULL	Recruiting	18 Years	80 Years	All	240	Phase 2	United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Netherlands;North Macedonia;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom
334	EUCTR2017-000573-37-PT (EUCTR)	13/03/2018	21/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
335	EUCTR2017-000573-37-IE (EUCTR)	13/03/2018	04/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
336	EUCTR2017-000572-28-PT (EUCTR)	13/03/2018	22/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
337	EUCTR2017-004230-28-BE (EUCTR)	09/03/2018	22/01/2018	BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Code: BI 655130 INN or Proposed INN: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	SCS Boehringer Ingelheim Comm. V	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Japan;China;Korea, Republic of
338	EUCTR2017-000599-27-GB (EUCTR)	07/03/2018	05/12/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan
339	NCT03398148 (ClinicalTrials.gov)	March 7, 2018	8/1/2018	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis (UC)	Drug: risankizumab IV;Drug: placebo for risankizumab;Drug: risankizumab SC	AbbVie	NULL	Recruiting	16 Years	80 Years	All	720	Phase 2;Phase 3	United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Czechia;Hungary
340	EUCTR2017-000573-37-GB (EUCTR)	07/03/2018	25/09/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
341	EUCTR2017-004230-28-AT (EUCTR)	27/02/2018	18/01/2018	BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis	A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy	Moderate-to-severely active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]	Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Product Name: spesolimab Product Code: BI 655130 INN or Proposed INN: Spesolimab Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1	Boehringer Ingelheim RCV GmbH & Co KG	NULL	Not Recruiting			Female: yes Male: yes	550	Phase 2;Phase 3	United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of
342	NCT03378921 (ClinicalTrials.gov)	February 27, 2018	11/12/2017	Fecal Microbiota Transplantation in the Treatment of Pouchitis	Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis	Pouchitis;Ulcerative Colitis	Biological: Fecal microbiota transplantation;Biological: Placebo	Helsinki University Central Hospital	NULL	Completed	18 Years	75 Years	All	26	Phase 2	Finland
343	EUCTR2017-000573-37-CZ (EUCTR)	27/02/2018	01/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
344	EUCTR2017-000599-27-CZ (EUCTR)	26/02/2018	01/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
345	EUCTR2017-000937-30-AT (EUCTR)	22/02/2018	03/01/2018	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
346	NCT03849599 (ClinicalTrials.gov)	February 21, 2018	17/2/2019	A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis	A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Biological: PRV-300;Biological: Placebo	Provention Bio, Inc.	NULL	Completed	18 Years	75 Years	All	37	Phase 1	Georgia;Moldova, Republic of;Ukraine
347	EUCTR2017-000572-28-FR (EUCTR)	16/02/2018	16/02/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
348	EUCTR2017-000572-28-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
349	EUCTR2017-000573-37-ES (EUCTR)	16/02/2018	19/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
350	NCT03259334 (ClinicalTrials.gov)	February 9, 2018	21/8/2017	Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative Colitis	Drug: Ontamalimab;Other: Placebo	Shire	NULL	Completed	16 Years	80 Years	All	380	Phase 3	United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
351	NCT03235752 (ClinicalTrials.gov)	February 6, 2018	28/7/2017	Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis	A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis	Active Ulcerative Colitis	Drug: TJ301 300mg;Drug: TJ301 600mg;Drug: Placebo	I-Mab Biopharma HongKong Limited	NULL	Recruiting	18 Years	70 Years	All	90	Phase 2	Australia;China;Korea, Republic of;Taiwan
352	EUCTR2017-000599-27-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
353	EUCTR2017-000573-37-LT (EUCTR)	30/01/2018	31/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
354	EUCTR2017-000402-38-PT (EUCTR)	29/01/2018	13/11/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: no Male: yes	250	Phase 2	Portugal;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
355	EUCTR2017-000573-37-BG (EUCTR)	24/01/2018	22/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
356	EUCTR2017-000402-38-DE (EUCTR)	23/01/2018	27/10/2017	A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	United States;Portugal;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
357	EUCTR2017-000573-37-HU (EUCTR)	22/01/2018	23/01/2018	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
358	EUCTR2017-000572-28-HU (EUCTR)	22/01/2018	27/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
359	EUCTR2017-000402-38-AT (EUCTR)	19/01/2018	30/10/2017	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;New Zealand;Sweden
360	EUCTR2017-000572-28-BG (EUCTR)	19/01/2018	24/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
361	EUCTR2017-000402-38-GB (EUCTR)	19/01/2018	23/10/2017	A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease	A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease	To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: GS-6034 INN or Proposed INN: FILGOTINIB	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: yes	250	Phase 2	United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden
362	EUCTR2017-000573-37-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
363	EUCTR2017-000599-27-AT (EUCTR)	22/12/2017	30/10/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand
364	NCT03269695 (ClinicalTrials.gov)	December 20, 2017	30/8/2017	Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.	A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC)	Ulcerative Colitis	Drug: PF-06687234;Drug: Placebo	Pfizer	NULL	Active, not recruiting	18 Years	75 Years	All	20	Phase 2	United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain
365	EUCTR2017-000937-30-PL (EUCTR)	13/12/2017	25/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Belgium;Poland;Austria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
366	EUCTR2017-000573-37-SK (EUCTR)	13/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
367	EUCTR2017-000572-28-SK (EUCTR)	13/12/2017	21/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: ontamalimab Product Code: SHP647 INN or Proposed INN: ontamalimab	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina
368	EUCTR2017-000572-28-GR (EUCTR)	11/12/2017	28/11/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 302).	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	825	Phase 3	United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of
369	EUCTR2017-000573-37-GR (EUCTR)	11/12/2017	01/12/2017	Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).	A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody Product Code: SHP647 INN or Proposed INN: Anti-MAdCAM antibody	Shire Human Genetic Therapies, Inc.	NULL	Not Recruiting			Female: yes Male: yes	772	Phase 3	United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
370	NCT03259308 (ClinicalTrials.gov)	December 5, 2017	21/8/2017	Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis	A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)	Ulcerative Colitis	Drug: Ontamalimab;Drug: Placebo	Shire	NULL	Terminated	16 Years	80 Years	All	279	Phase 3	United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Turkey;Ukraine;France
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
371	EUCTR2017-000937-30-ES (EUCTR)	27/11/2017	10/10/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Poland;Belgium;Spain;Austria;Germany
372	EUCTR2016-000420-26-BG (EUCTR)	17/11/2017	19/04/2017	A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.	A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Bimekizumab Product Code: UCB4940 INN or Proposed INN: Bimekizumab Other descriptive name: UCB4940	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy
373	NCT03266484 (ClinicalTrials.gov)	November 13, 2017	25/8/2017	Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease	Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial	Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis	Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo	Massachusetts General Hospital	Winclove Bio Industries BV	Recruiting	18 Years	75 Years	All	100	N/A	United States
374	EUCTR2016-003708-29-NL (EUCTR)	09/11/2017	19/07/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
375	EUCTR2017-000937-30-FR (EUCTR)	07/11/2017	19/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
376	EUCTR2016-001392-78-NL (EUCTR)	06/11/2017	16/08/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
377	EUCTR2013-004278-88-PL (EUCTR)	24/10/2017	09/09/2017	A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.	PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY	Ulcerative colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: etrolizumab Product Code: Ro 549-0261/F04 INN or Proposed INN: ETROLIZUMAB Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	605	Phase 3	United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of
378	EUCTR2017-000937-30-DE (EUCTR)	10/10/2017	25/09/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		ABIVAX	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	France;Hungary;Spain;Poland;Belgium;Austria;Germany
379	NCT03093259 (ClinicalTrials.gov)	October 1, 2017	17/3/2017	ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis	Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids	Ulcerative Colitis	Drug: ABX464;Drug: Placebo oral capsule	Abivax S.A.	NULL	Completed	18 Years	70 Years	All	32	Phase 2	Belgium
380	EUCTR2017-000937-30-BE (EUCTR)	29/09/2017	03/08/2017	Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.	A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.	Moderate to severe Ulcerative Colitis. MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: ABX464 INN or Proposed INN: ABX464 Other descriptive name: ABX464	ABIVAX	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	30	Phase 2	Hungary;Spain;Poland;Belgium;Austria;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
381	EUCTR2017-001389-10-GB (EUCTR)	28/09/2017	17/08/2017	Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial	A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO	Acute Severe Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Cambridge University Hospitals NHS Foundation Trust & University of Cambridge	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	214	Phase 2	United Kingdom
382	EUCTR2016-000641-31-HR (EUCTR)	21/08/2017	06/11/2017	Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
383	EUCTR2016-003708-29-AT (EUCTR)	07/08/2017	24/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of
384	EUCTR2016-003708-29-DE (EUCTR)	07/08/2017	24/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of
385	NCT03221036 (ClinicalTrials.gov)	August 3, 2017	14/7/2017	Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis	Drug: Vedolizumab IV;Drug: Placebo	Takeda	NULL	Recruiting	18 Years	80 Years	All	302	Phase 3	China
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
386	EUCTR2016-003708-29-HU (EUCTR)	30/06/2017	11/05/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
387	EUCTR2016-003708-29-DK (EUCTR)	27/06/2017	21/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
388	EUCTR2016-001392-78-HR (EUCTR)	26/06/2017	12/09/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Georgia;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia
389	EUCTR2016-003452-75-NL (EUCTR)	23/06/2017	04/01/2017	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina
390	NCT03178669 (ClinicalTrials.gov)	June 21, 2017	5/6/2017	The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis	A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients	Ulcerative Colitis	Drug: cobitolimod;Drug: Placebo	InDex Pharmaceuticals	NULL	Active, not recruiting	18 Years	N/A	All	213	Phase 2	Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
391	NCT03122613 (ClinicalTrials.gov)	June 19, 2017	7/4/2017	Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis	A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis	Ulcerative Colitis in Remission	Dietary Supplement: Curcumin;Drug: Placebo	Chinese University of Hong Kong	NULL	Recruiting	18 Years	N/A	All	172	N/A	Hong Kong
392	NCT03123120 (ClinicalTrials.gov)	June 7, 2017	13/4/2017	A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy	Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy	Colitis, Ulcerative	Drug: Spesolimab;Drug: Placebo	Boehringer Ingelheim	NULL	Completed	18 Years	75 Years	All	22	Phase 2	Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland
393	EUCTR2016-003708-29-PL (EUCTR)	07/06/2017	26/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
394	EUCTR2016-003708-29-LT (EUCTR)	06/06/2017	18/04/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 2	Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of
395	EUCTR2016-001392-78-SE (EUCTR)	24/05/2017	12/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
396	EUCTR2016-000641-31-FR (EUCTR)	22/05/2017	02/06/2017	Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494 Product Name: ABT-494 INN or Proposed INN: ABT-494 Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden;Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China
397	EUCTR2016-003708-29-ES (EUCTR)	22/05/2017	31/05/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc., 235 East 42nd Street, New York, NY 10017	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Serbia;United States;Philippines;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of
398	NCT02954159 (ClinicalTrials.gov)	May 18, 2017	14/10/2016	Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC	Induction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis	Drug: Tacrolimus;Drug: Vedolizumab;Other: Placebo	Medical College of Wisconsin	Takeda	Terminated	18 Years	65 Years	All	4	Phase 3	United States
399	EUCTR2015-001942-28-FR (EUCTR)	16/05/2017	02/12/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
400	EUCTR2016-003452-75-HR (EUCTR)	11/05/2017	07/06/2017	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
401	NCT03103412 (ClinicalTrials.gov)	May 4, 2017	24/3/2017	TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)	Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)	Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects	Drug: TD-3504;Drug: 15N2-tofacitinib;Drug: Placebo	Theravance Biopharma	NULL	Completed	18 Years	55 Years	All	32	Phase 1	United States
402	NCT03415711 (ClinicalTrials.gov)	April 28, 2017	5/1/2018	PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis	A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC	Ulcerative Colitis	Dietary Supplement: VSL#3®;Drug: Mesalamine;Drug: Placebo	VSL Pharmaceuticals	Actial Farmaceutica S.r.l.	Terminated	18 Years	85 Years	All	14	N/A	Italy
403	EUCTR2016-001833-29-NL (EUCTR)	24/04/2017	23/01/2017	A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis	A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.	Active ulcerative colitis MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GSK2982772 Product Code: GSK2982772 INN or Proposed INN: Not Available Other descriptive name: GSK2982772A, where A denotes the free base	GlaxoSmithKline Research & Development Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	Poland;Germany;Netherlands;United Kingdom;Sweden
404	EUCTR2016-001392-78-IS (EUCTR)	24/04/2017	21/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1300	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
405	EUCTR2016-001684-36-ES (EUCTR)	19/04/2017	10/03/2017	EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS	A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS	Ulcerative Colitis MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: GED-0507-34-Levo Product Code: GED0507 INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Other descriptive name: GED-0507-34-LEVO	PPM SERVICES SA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 2	France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
406	EUCTR2016-003708-29-SK (EUCTR)	18/04/2017	24/02/2017	Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon	A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato	Moderate to severe Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: PF-06651600 10 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06651600 50 mg INN or Proposed INN: PF-06651600 Other descriptive name: PF-06651600 -15 Product Code: PF-06700841 5 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Code: PF-06700841 25 mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15	Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of;United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel
407	EUCTR2016-001392-78-BG (EUCTR)	04/04/2017	07/02/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;Japan;New Zealand;Sweden
408	EUCTR2016-003452-75-CZ (EUCTR)	03/04/2017	19/12/2016	A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon	A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS	Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A Product Name: PTG-100 Product Code: PTG-100 INN or Proposed INN: - Other descriptive name: PN-10884A	Protagonist Therapeutics, Inc	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Serbia;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina
409	EUCTR2016-001392-78-GR (EUCTR)	31/03/2017	14/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
410	EUCTR2016-001392-78-BE (EUCTR)	31/03/2017	09/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
411	EUCTR2016-000641-31-LT (EUCTR)	31/03/2017	11/10/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan
412	EUCTR2016-001392-78-DE (EUCTR)	27/03/2017	05/04/2017	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden
413	EUCTR2015-001942-28-DE (EUCTR)	27/03/2017	13/10/2015	A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Code: APD334 INN or Proposed INN: Not yet available Product Code: APD334 INN or Proposed INN: Not yet available	Arena Pharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand
414	EUCTR2015-002558-11-BG (EUCTR)	14/03/2017	06/01/2017	A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis	Ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
415	EUCTR2015-002557-35-BG (EUCTR)	14/03/2017	06/01/2017	A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis	A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis	Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]		Ferring International PharmaScience Center U.S., Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
416	EUCTR2016-001392-78-PT (EUCTR)	13/03/2017	13/12/2016	A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis	Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis	Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib	Gilead Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	1300	Phase 2;Phase 3	United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden
417	EUCTR2016-000641-31-CZ (EUCTR)	02/03/2017	29/09/2016	Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis	A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis	Ulcerative Colitis MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494 Product Name: Upadacitinib Product Code: ABT-494 INN or Proposed INN: Upadacitinib Other descriptive name: ABT-494	AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	1055	Phase 2;Phase 3	Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04469062
(ClinicalTrials.gov)

April 20, 2021

10/7/2020

A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis

A Phase 3b, Randomized, Double-Blind, Parallel-Arm, Placebo- and Active- Controlled Treat-Through Study of Mirikizumab and Vedolizumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Mirikizumab IV;Drug: Mirikizumab SC;Drug: Vedolizumab IV;Drug: Placebo IV;Drug: Placebo SC

Eli Lilly and Company

NULL

Not yet recruiting

18 Years

80 Years

All

1100

Phase 3

NULL

NCT04314375
(ClinicalTrials.gov)

April 2021

17/3/2020

Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: Placebo

Bausch Health Americas, Inc.

NULL

Not yet recruiting

5 Years

17 Years

All

Phase 4

NULL

NCT04596293
(ClinicalTrials.gov)

January 31, 2021

15/10/2020

Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis

A Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects With Moderate to Severe Ulcerative Colitis, Incorporating a Response-adaptive, Double-blind Extension Phase

Ulcerative Colitis

Drug: BBT-401-1S;Drug: Placebo

Bridge Biotherapeutics, Inc.

Covance

Not yet recruiting

18 Years

60 Years

All

Phase 2

NULL

NCT04630028
(ClinicalTrials.gov)

January 8, 2021

13/11/2020

A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Ustekinumab Dose Based on BSA and Body Weight;Drug: Matching Placebo

Janssen Research & Development, LLC

NULL

Not yet recruiting

2 Years

17 Years

All

Phase 3

United States;Belgium;Germany;Hungary;Japan;Poland;Russian Federation;United Kingdom

EUCTR2020-001398-59-HR
(EUCTR)

02/12/2020

07/12/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Randomized, double-blind, Phase 2 study to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with moderate to severe active ulcerative colitis who have failed or are intolerant to previous treatment(s)

Moderate to severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: OSE-127
Product Code: OSE-127
INN or Proposed INN: AS INN
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002698-74-GB
(EUCTR)

17/11/2020

30/03/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO CONTROLLED DOSE-RANGINGSTUDY TO EVALUATE THE EFFICACY, SAFETY, ANDPHARMACOKINETICS OF PF-06480605 IN ADULTPARTICIPANTS WITH MODERATE TO SEVEREULCERATIVE COLITIS - Tuscany 2

A phase 2b randomised, double-blind, placebo controlled dose-ranging study in Adults with Moderate to Severe Ulcerative Colitis
MedDRA version: 20.0;Level: HLT;Classification code 10009888;Term: Colitis (excl infective);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;India;France;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;South Africa;Bulgaria;Germany;China;Japan

NCT04613518
(ClinicalTrials.gov)

November 13, 2020

28/10/2020

A Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Participants With Moderate to Severe Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative

Drug: BMS-986165 Dose 1;Drug: BMS-986165 Dose 2;Other: Placebo Comparator

Bristol-Myers Squibb

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 2

Australia;Canada;Germany;Netherlands;Puerto Rico

NCT04607837
(ClinicalTrials.gov)

November 10, 2020

23/10/2020

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis

Ulcerative Colitis

Drug: Etrasimod;Drug: Placebo

Arena Pharmaceuticals

NULL

Not yet recruiting

18 Years

80 Years

All

162

Phase 2

NULL

NCT04543994
(ClinicalTrials.gov)

November 10, 2020

3/9/2020

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)

A Phase IB/IIA Study of Remestemcel-L, an ex Vivo Culture-expanded Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cell Product, for the Treatment of Medically Refractory Ulcerative Colitis

Ulcerative Colitis

Drug: Remestemcel-L;Other: Placebo

The Cleveland Clinic

Mesoblast, Inc.

Recruiting

18 Years

75 Years

All

Phase 1;Phase 2

United States

ChiCTR2000038888

2020-10-19

2020-10-09

Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial

A systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility

Ulcerative colitis

control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;

Chengdu University of Traditional Chinese Medicine

NULL

Recruiting

Female

control group:118;experimental group:118;

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04556383
(ClinicalTrials.gov)

October 19, 2020

15/9/2020

A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis

Ulcerative Colitis

Drug: GB004;Drug: Placebo

GB004, Inc.

NULL

Recruiting

18 Years

N/A

All

195

Phase 2

United States

EUCTR2020-001398-59-BG
(EUCTR)

13/10/2020

18/09/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Product Name: OSE-127
Product Code: OSE-127
INN or Proposed INN: OSE-127
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

EUCTR2020-000047-31-FR
(EUCTR)

07/10/2020

13/05/2020

A study of AMT-101 in patients with Ulcerative Colitis.

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMT -101
INN or Proposed INN: Not yet assigned
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

102

Phase 2

United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of

NCT04577794
(ClinicalTrials.gov)

October 5, 2020

30/9/2020

A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of GLPG3970, Administered Orally for 6 Weeks in Adult Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: GLPG3970;Drug: Placebo

Galapagos NV

NULL

Recruiting

18 Years

64 Years

All

Phase 2

Georgia;Moldova, Republic of;Poland;Ukraine

NCT04353791
(ClinicalTrials.gov)

October 2020

24/3/2020

Study of OST-122 in Patients With Moderate to Severe Ulcerative Colitis

A Phase Ib/IIa, Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral Treatment With OST-122 in Patients With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe

Drug: OST-122;Drug: Placebo

Oncostellae S.L

NULL

Recruiting

18 Years

75 Years

All

Phase 1;Phase 2

Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2020-001398-59-LV
(EUCTR)

21/09/2020

28/07/2020

Clinical trial to evaluate the efficacy and the safety of OSE-127 versus placebo in subjects with ulcerative colitis who have failed or are intolerant to previous treatment(s)

Product Name: OSE-127
Product Code: OSE-127
Other descriptive name: humanized recombinant IgG4 monoclonal antibody against CD-127

OSE Immunotherapeutics

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Belarus;Serbia;Ukraine;Lithuania;Russian Federation;France;Hungary;Belgium;Poland;Croatia;Bulgaria;Georgia;Latvia

NCT04223518
(ClinicalTrials.gov)

September 20, 2020

6/1/2020

Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease (IBD)

Safety, Tolerability, and Nutritional Impact of Serum Bovine Immunoglobulin (SBI) in Children and Young Adults With Inflammatory Bowel Disease

Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease

Dietary Supplement: Serum bovine immunoglobulin;Dietary Supplement: Placebo

Monisha Hitesh Shah

NULL

Recruiting

6 Years

30 Years

All

Early Phase 1

United States

NCT03996369
(ClinicalTrials.gov)

September 15, 2020

21/6/2019

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Etrasimod;Drug: Placebo

Arena Pharmaceuticals

NULL

Recruiting

16 Years

80 Years

All

330

Phase 3

Georgia;Japan;Poland;Russian Federation;Thailand;Ukraine

EUCTR2020-000047-31-HU
(EUCTR)

09/09/2020

07/07/2020

A study of AMT-101 in patients with Ulcerative Colitis.

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMT -101
INN or Proposed INN: Not yet assigned
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

102

Phase 2

United States;Serbia;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;India;France;Hungary;Canada;Poland;Belgium;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Netherlands;Moldova, Republic of

EUCTR2019-002698-74-DE
(EUCTR)

08/09/2020

21/02/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04205643
(ClinicalTrials.gov)

September 2, 2020

18/12/2019

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: CT-P13 SC (Infliximab);Other: Placebo SC

Celltrion

NULL

Recruiting

18 Years

75 Years

All

615

Phase 3

Poland

NCT04583358
(ClinicalTrials.gov)

August 26, 2020

16/9/2020

Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects With Moderate to Severe Ulcerative Colitis (LOMBARD)

Ulcerative Colitis

Drug: AMT -101 (oral);Other: Placebo (oral)

Applied Molecular Transport

NULL

Recruiting

18 Years

80 Years

All

102

Phase 2

United States;Canada;Georgia;Hungary;Moldova, Republic of

EUCTR2019-003999-39-NO
(EUCTR)

17/08/2020

29/04/2020

A placebo-controlled study followed by an open label treatment to evaluate the safety and efficacy of PF-06826647 in participants with moderate to severe ulcerative colitis

A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL EXTENSION TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

moderate to severe ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PF-06826647
Product Code: PF-06826647
INN or Proposed INN: PF-06826647

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

202

Phase 2

United States;United Arab Emirates;Qatar;Saudi Arabia;Hong Kong;Slovakia;Morocco;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Puerto Rico;Jordan;Malaysia;Australia;Tunisia;China;Bosnia and Herzegovina;Oman;Turkey;United Kingdom;Czech Republic;Armenia;Mexico;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Germany;Norway

EUCTR2019-004469-41-DE
(EUCTR)

11/08/2020

26/03/2020

A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)

A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects with Moderate to Severe Active Ulcerative Colitis

Ulcerative colitis (US) is a chronic relapsing inflammatory bowel disease of the large intestine characterized by bloody diarrhoea, abdominal cramps and fatigue. UC is characterized by inflammation and ulceration of mainly the mucosal and occasionally submucosal intestinal layers.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943

Protagonist Therapeutics, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of

EUCTR2019-004469-41-BG
(EUCTR)

11/08/2020

27/04/2020

A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)

Product Code: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943

Protagonist Therapeutics, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04504383
(ClinicalTrials.gov)

August 5, 2020

5/8/2020

PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis

Ulcerative Colitis Chronic Moderate;Ulcerative Colitis Chronic Severe

Drug: PN-943;Drug: Placebo

Protagonist Therapeutics, Inc.

NULL

Recruiting

18 Years

75 Years

All

150

Phase 2

United States;Bulgaria;Canada;Hungary;Korea, Republic of;Poland

EUCTR2020-000047-31-GB
(EUCTR)

03/08/2020

20/04/2020

A study of AMT-101 in patients with Ulcerative Colitis.

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMT -101
INN or Proposed INN: Not yet assigned
Other descriptive name: AMT -101

Applied Molecular Transport Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

102

Phase 2

Serbia;United States;Belarus;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Canada;Poland;Romania;Kazakhstan;Bulgaria;Georgia;Germany;Moldova, Republic of

NCT04469686
(ClinicalTrials.gov)

July 30, 2020

2/7/2020

Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis

Ulcerative Proctitis

Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator;Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator;Combination Product: Twice daily placebo suppository administered with Sephure applicator

Cristcot LLC

Cristcot HCA LLC

Recruiting

18 Years

N/A

All

618

Phase 3

United States

EUCTR2019-003596-19-DE
(EUCTR)

29/07/2020

A Three-Arm, Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Safety and Efficacy of Once-Daily and Twice-Daily Dosing of a Novel Hydrocortisone Acetate 90 mg Suppository Formulation Administered with the Sephure® Suppository Applicator in Subjects with Ulcerative Colitis of the Rectum.

Ulcerative Colitis of the Rectum
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;Level: HLT;Classification code 10027682;Term: Immune and associated conditions NEC;System Organ Class: 10021428 - Immune system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;Level: HLGT;Classification code 10027665;Term: Immune disorders NEC;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 90 mg hydrocortisone acetate suppository with Sephure suppository applicator
INN or Proposed INN: HYDROCORTISONE ACETATE

Cristcot HCA LLC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

618

Phase 3

United States;Philippines;Hong Kong;Spain;Poland;Ukraine;Romania;Russian Federation;Germany;Italy;India

EUCTR2019-004469-41-AT
(EUCTR)

27/07/2020

26/03/2020

A trial to investigate the safety and efficacy of PN-943 in patients with moderate or severe Ulcerative Colitis (a long-term condition where the colon and rectum become inflamed)

Product Code: PN-943
Other descriptive name: PN-943
Product Code: PN-943
Other descriptive name: PN-943

Protagonist Therapeutics, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

Serbia;United States;Ukraine;Austria;Russian Federation;Italy;Hungary;Canada;Poland;Bulgaria;Georgia;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04373473
(ClinicalTrials.gov)

July 15, 2020

28/4/2020

Evaluation the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation Administered Orally for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

A Phase 2a, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lyophilized Fecal Microbiota Transplantation (PRIM-DJ2727) Administered Orally in Combination With Standard of Care Therapy for Prevention of Relapse or Intestinal Inflammation in Adults With Ulcerative Colitis

Adults With Ulcerative Colitis

Drug: PRIM-DJ2727;Drug: Placebos

The University of Texas Health Science Center, Houston

NULL

Not yet recruiting

18 Years

N/A

All

Phase 2

NULL

NCT04458805
(ClinicalTrials.gov)

July 10, 2020

16/6/2020

Safety, Tolerability and Pharmacokinetics of Oral NX-13 in Healthy Adults Male and Female Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral NX-13 in Healthy Adult Male and Female Volunteers

Ulcerative Colitis

Drug: NX-13 250 mg;Drug: Placebo

Landos Biopharma Inc.

NULL

Active, not recruiting

18 Years

64 Years

All

Phase 1

Australia

EUCTR2018-003986-33-PT
(EUCTR)

06/07/2020

28/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

EUCTR2018-004002-25-NL
(EUCTR)

06/07/2020

17/09/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis - QUASAR

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

Poland;Romania;Bulgaria;Germany;Japan;Sweden;United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium

EUCTR2018-004694-27-FR
(EUCTR)

06/07/2020

10/04/2020

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03935451
(ClinicalTrials.gov)

July 1, 2020

23/4/2019

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study

IBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal Disorders

Drug: Apixaban 2.5 milligram;Drug: Placebo Oral Tablet

McMaster University

NULL

Not yet recruiting

18 Years

N/A

All

Early Phase 1

NULL

ChiCTR2000033953

2020-07-01

2020-06-18

Effect of the probiotic on symptoms in patients with ulcerative colitis (UC)

Ulcerative colitis

Placebo group:Maltodextrin;experimental group 1:Lactobacillus plantarum CCFM8610;experimental group 2:Lactobacillus plantarum N13;experimental group 3:Lactobacillus casei CCFM1059;

Jiangnan University

NULL

Pending

Both

Placebo group:20;experimental group 1:20;experimental group 2:20;experimental group 3:20;

China

NCT04457960
(ClinicalTrials.gov)

July 1, 2020

1/7/2020

A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative Colitis

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433

Healthy;Colitis, Ulcerative

Drug: JNJ-66525433;Drug: Placebo

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

60 Years

All

128

Phase 1

Georgia;Germany;Moldova, Republic of

NCT04209556
(ClinicalTrials.gov)

June 30, 2020

1/12/2019

A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis

Ulcerative Colitis

Drug: PF-06826647 100 mg QD;Drug: PF-06826647 300 mg QD;Drug: PF-06826647 600 mg QD;Drug: Placebo;Drug: PF-6826647 400 mg QD

Pfizer

NULL

Recruiting

18 Years

75 Years

All

202

Phase 2

United States

EUCTR2019-003334-16-DE
(EUCTR)

26/06/2020

05/05/2020

Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis

Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis

acute ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budenofalk® suppositories
INN or Proposed INN: BUDESONIDE
Other descriptive name: Budenofalk® suppositories (BUS)
Trade Name: Salofalk 3g gastro-resistant prolonged-release granules
Product Name: Salofalk 3g gastro-resistant prolonged-release granules
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 3

Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-001430-33-DE
(EUCTR)

18/06/2020

25/02/2020

A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis

A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis

ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-4875
Product Code: GS-4875

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany

EUCTR2019-003849-15-HR
(EUCTR)

05/06/2020

20/11/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Czechia;Turkey;Austria;Hungary;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-002698-74-BE
(EUCTR)

03/06/2020

02/04/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan

NCT04259060
(ClinicalTrials.gov)

June 2020

27/1/2020

Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis Research

Hydroxocobalamin Approach to Reduction of Nitrite With Butyrate for Ulcerative Colitis

Ulcerative Colitis

Drug: Hydroxocobalamin with Butyrate;Drug: Placebo with Butyrate

Joshua Korzenik

NULL

Not yet recruiting

18 Years

75 Years

All

Phase 2

United States

JPRN-JapicCTI-194980

22/5/2020

30/09/2019

A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Intervention name : Guselkumab
INN of the intervention : Guselkumab
Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC.

Janssen Pharmaceutical K.K.

NULL

recruiting

BOTH

950

Phase 2b;Phase 3

Japan, Asia except Japan, North America, Europe

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002698-74-FR
(EUCTR)

20/05/2020

24/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China

EUCTR2019-001430-33-AT
(EUCTR)

15/05/2020

31/01/2020

A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis

A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-4875
Product Code: GS-4875

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany

EUCTR2018-004002-25-BG
(EUCTR)

13/05/2020

24/02/2020

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: GUSELKUMAB
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab
Product Name: guselkumab
Product Code: CNTO1959
INN or Proposed INN: Guselkumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

EUCTR2019-003849-15-ES
(EUCTR)

12/05/2020

28/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-001430-33-GB
(EUCTR)

05/05/2020

21/02/2020

A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis

A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis

ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-4875
INN or Proposed INN: to be confirmed
Product Code: GS-4875
INN or Proposed INN: to be confirmed

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

180

Phase 2

United States;Czechia;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Poland;Australia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003113-34-NO
(EUCTR)

04/05/2020

21/01/2020

Ulcerative colitis

A randomized, multi-center, subject and investigator blinded, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis - NA

Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Czech Republic;Poland;Russian Federation;Bulgaria;Germany;Norway

EUCTR2018-003278-28-BG
(EUCTR)

22/04/2020

23/05/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

A multicentre randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Czechia;Estonia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of

EUCTR2019-002698-74-HU
(EUCTR)

15/04/2020

20/04/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China

EUCTR2018-004002-25-DE
(EUCTR)

07/04/2020

23/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

EUCTR2018-003986-33-AT
(EUCTR)

07/04/2020

20/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-003703-22-BG
(EUCTR)

07/04/2020

06/02/2020

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1

Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Belarus;Portugal;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

EUCTR2019-003849-15-GR
(EUCTR)

03/04/2020

02/04/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-003849-15-BG
(EUCTR)

03/04/2020

07/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

Serbia;Belarus;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;France;Czech Republic;Mexico;Poland;Croatia;Peru;South Africa;Bulgaria;Germany;Latvia;Moldova, Republic of

EUCTR2019-003849-15-FR
(EUCTR)

03/04/2020

03/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2019-001430-33-FR
(EUCTR)

02/04/2020

20/02/2020

A clinical trial to see if GS-4875 is effective and safe in treating people with moderate to severe ulcerative colitis

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects with Moderately to Severely Active Ulcerative Colitis

ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-4875
Product Code: GS-4875

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04276740
(ClinicalTrials.gov)

April 1, 2020

12/2/2020

MARVEL: Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis

Mitochondrial Anti-oxidant Therapy to Resolve Inflammation in Ulcerative Colitis (MARVEL): A Randomised Placebo-controlled Trial on Oral MitoQ in Moderate UC

Ulcerative Colitis Flare

Dietary Supplement: MitoQ;Other: Placebo

University of Edinburgh

JP Moulton Charitable Foundation;MitoQ

Not yet recruiting

18 Years

N/A

All

206

Phase 2

NULL

EUCTR2019-002698-74-ES
(EUCTR)

01/04/2020

23/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

NCT04225819
(ClinicalTrials.gov)

April 1, 2020

3/1/2020

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD

Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial

IBD;Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Vitamin D3 Deficiency

Dietary Supplement: Vitamin D3;Other: Placebo

Massachusetts General Hospital

NULL

Not yet recruiting

18 Years

N/A

All

100

N/A

NULL

NCT04096573
(ClinicalTrials.gov)

April 2020

18/9/2019

Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis

A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: LC51-0255;Drug: Placebo

LG Chem

NULL

Not yet recruiting

18 Years

80 Years

All

240

Phase 2

NULL

EUCTR2019-002698-74-BG
(EUCTR)

27/03/2020

31/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Austria;Russian Federation;Israel;Italy;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-002698-74-SK
(EUCTR)

26/03/2020

31/01/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - Tuscany 2

Product Name: PF-06480605 100 mg/ml
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Turkey;Russian Federation;Israel;Italy;India;France;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Japan;China

EUCTR2019-002698-74-PL
(EUCTR)

24/03/2020

11/02/2020

A study to evaluate the efficacy and safety of PF 06480605 in adult participants with moderate to severe ulcerative colitis

Product Name: PF-06480605
Product Code: PF-06480605
INN or Proposed INN: PF-06480605
Other descriptive name: Anti-TL1A

Pfizer Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

EUCTR2019-003849-15-AT
(EUCTR)

20/03/2020

06/02/2020

Evaluating efficacy and safety of subcutaneous CT-P13 (CT-P13 SC) asmaintenance therapy in patients with Ulcerative Colitis

A Randomized, Placebo Controlled, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of the Subcutaneous Injection of CT-P13 (CT-P13 SC) as Maintenance Therapy in Patients with Moderately to Severely Active Ulcerative Colitis

Trade Name: Remsima
Product Code: Remsima (CT-P13)
INN or Proposed INN: INFLIXIMAB
Trade Name: Inflectra
Product Code: CT-P13
INN or Proposed INN: INFLIXIMAB

Celltrion, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

615

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Italy;France;Peru;South Africa;Latvia;Moldova, Republic of;Turkey;Austria;Hungary;Czech Republic;Mexico;Brazil;Poland;Croatia;Bulgaria;Germany

EUCTR2016-000642-62-SE
(EUCTR)

18/03/2020

25/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

462

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

EUCTR2016-000642-62-FR
(EUCTR)

10/03/2020

30/07/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-001605-93-AT
(EUCTR)

09/03/2020

07/11/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis - Phase 2 Dose-finding UC Study

Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139
Trade Name: Entyvio
INN or Proposed INN: Entyvio
Other descriptive name: VEDOLIZUMAB
Product Name: Brazikumab
Product Code: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human
INN or Proposed INN: BRAZIKUMAB
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; previously referred to as MEDI2070 and AMG 139

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan

EUCTR2017-003703-22-PT
(EUCTR)

02/03/2020

18/12/2019

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Portugal;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

NCT02277223
(ClinicalTrials.gov)

March 1, 2020

25/10/2014

Curcumin in Pediatric Ulcerative Colitis

Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis

Ulcerative Colitis

Dietary Supplement: Curcumin;Drug: Placebo

Schneider Children's Medical Center, Israel

NULL

Recruiting

6 Years

18 Years

All

Phase 3

Israel

EUCTR2018-004002-25-ES
(EUCTR)

28/02/2020

04/09/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 2;Phase 3

Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden

EUCTR2018-003986-33-DK
(EUCTR)

28/02/2020

02/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Moldova, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2019-003113-34-HU
(EUCTR)

25/02/2020

09/01/2020

Study of efficacy, safety and tolerability of LYS006 in patients with mild to moderate ulcerative colitis

Mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Czech Republic;Hungary;Poland;Russian Federation;Bulgaria;Norway;Germany

EUCTR2018-003986-33-GB
(EUCTR)

24/02/2020

17/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

EUCTR2019-003113-34-DE
(EUCTR)

19/02/2020

08/11/2019

Ulcerative colitis

Product Name: LYS006
Product Code: LYS006
INN or Proposed INN: not yet defined
Other descriptive name: LYS006

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Czech Republic;Norway;Germany

EUCTR2018-003986-33-ES
(EUCTR)

14/02/2020

24/02/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

EUCTR2018-003986-33-BG
(EUCTR)

11/02/2020

23/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003558-26-GB
(EUCTR)

11/02/2020

05/11/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

A randomized, double blind, placebo controlled, parallel group, multiple dose, induction study to evaluate the safety, tolerability and optimal dose of ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have inadequate response, loss of response, or intolerance with at least one of the following agents: immunosuppressant treatment (i.e. azathioprine, 6-mercaptopurine, methotrexate), tumor necrosis factor alpha [TNF-a] inhibitors, vedolizumab, JAK inhibitors and/or corticosteroid treatment. - Investigate the safety and efficacy of study drug ABX464-103

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

EUCTR2019-004090-50-ES
(EUCTR)

07/02/2020

11/11/2019

Clinical Trial to evaluate the safety and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis

A Phase Ib/IIa, randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety, pharmacokinetics and efficacy of oral treatment with OST-122 in patients with moderate to severe ulcerative colitis

Moderate to severe ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ONCOSTELLAE S.L.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1;Phase 2

Spain

NCT04074590
(ClinicalTrials.gov)

February 3, 2020

29/8/2019

Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis

A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis

Colitis, Ulcerative

Drug: LYS006;Drug: Placebo

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

65 Years

All

Phase 2

United States;Bulgaria;Czechia;Germany;Hungary;Norway;Poland;Russian Federation

EUCTR2018-004002-25-PT
(EUCTR)

03/02/2020

06/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

Portugal;United States;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden

NCT04202211
(ClinicalTrials.gov)

February 2020

13/12/2019

FMT for Remission of Active Ulcerative Colitis in Adults

A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis

Ulcerative Colitis;Inflammatory Bowel Diseases

Biological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enema

University of British Columbia

Crohn's and Colitis Canada;Vancouver Island Health Authority

Not yet recruiting

18 Years

N/A

All

145

Phase 2

Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03998488
(ClinicalTrials.gov)

January 31, 2020

24/6/2019

Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis

A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis

Ulcerative Colitis;Inflammatory Bowel Diseases

Drug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk Powder

Weill Medical College of Cornell University

Crohn's and Colitis Foundation

Recruiting

18 Years

89 Years

All

135

Phase 2

United States

EUCTR2018-003986-33-LV
(EUCTR)

24/01/2020

01/11/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

South Africa;Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

EUCTR2018-003985-15-AT
(EUCTR)

21/01/2020

08/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

EUCTR2018-003985-15-FR
(EUCTR)

20/01/2020

12/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

NCT04223479
(ClinicalTrials.gov)

January 15, 2020

6/1/2020

Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan

Ulcerative Colitis

Drug: Probiotic Formula Capsule;Drug: Placebos

University of Jordan

NULL

Recruiting

35 Years

65 Years

All

Phase 2;Phase 3

Jordan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003986-33-FR
(EUCTR)

14/01/2020

20/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

EUCTR2018-003986-33-LT
(EUCTR)

31/12/2019

08/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

NCT04130919
(ClinicalTrials.gov)

December 20, 2019

16/10/2019

Study to Evaluate the Efficacy and Safety of GS-4875 in Adults With Moderately to Severely Active Ulcerative Colitis

A Phase 2, Blinded, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: GS-4875;Drug: Placebo

Gilead Sciences

NULL

Recruiting

18 Years

N/A

All

180

Phase 2

United States;Australia;Austria;Canada;France;Germany;Italy;Poland;Switzerland

NCT04090411
(ClinicalTrials.gov)

December 19, 2019

12/9/2019

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis

Drug: 50 mg;Drug: 450 mg;Drug: 150 mg;Other: 0 mg

Pfizer

NULL

Recruiting

18 Years

75 Years

All

240

Phase 2

United States;Australia;Belgium;Bulgaria;France;Hungary;India;Italy;Japan;Poland;Russian Federation;Slovakia;Spain;Thailand;Turkey;Ukraine;Canada;United Kingdom

EUCTR2018-005086-39-HR
(EUCTR)

16/12/2019

17/01/2020

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifestations: ulcerative colitis (UC) and Crohn’s disease (CD). UC manifests through complex interactions between the gut microbiome, dysregulated immune responses, genetic mutations, diet, and other environmental factors.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: BT-11 500 mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11
Product Name: BT-11 1000mg
Product Code: BT-11
INN or Proposed INN: to be requested
Other descriptive name: BT-11

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

Belarus;Serbia;United States;Ukraine;Russian Federation;Hungary;Canada;Poland;Croatia;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003278-28-NL
(EUCTR)

13/12/2019

22/07/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Czechia;Estonia;Slovenia;Slovakia;Ukraine;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Korea, Republic of

EUCTR2018-003558-26-FR
(EUCTR)

10/12/2019

08/02/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Serbia;Belarus;Slovakia;Slovenia;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Netherlands;Germany

EUCTR2017-003703-22-HR
(EUCTR)

20/11/2019

13/01/2020

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Belarus;Portugal;Czechia;Spain;Ukraine;North Macedonia;Russian Federation;United Kingdom;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

EUCTR2018-003986-33-HR
(EUCTR)

08/11/2019

17/01/2020

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

100

EUCTR2018-003986-33-HU
(EUCTR)

07/11/2019

08/11/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

101

EUCTR2016-000642-62-DE
(EUCTR)

04/11/2019

18/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

102

EUCTR2018-003349-41-DE
(EUCTR)

30/10/2019

19/12/2018

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine
Product Name: ST-0529
Product Code: FP-CYA-053
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany

103

EUCTR2018-003558-26-DE
(EUCTR)

30/10/2019

15/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

Belarus;Serbia;Czechia;Slovenia;Slovakia;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany;Netherlands

104

EUCTR2018-005086-39-HU
(EUCTR)

28/10/2019

08/04/2019

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacyand Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Product Code: BT-11
INN or Proposed INN: to be requested
Product Code: BT-11
INN or Proposed INN: to be requested

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina

105

EUCTR2018-003278-28-HU
(EUCTR)

24/10/2019

25/03/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

A multicentre randomized, double-blind (sponsor open), placebo-controlled Phase 2 study to evaluate the safety, tolerability, efficacy, dose-response, pharmacokinetics and pharmacodynamics of repeat dosing of an anti-LAG3 cell depleting monoclonal antibody (GSK2831781) in patients with active ulcerative colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

106

EUCTR2018-003985-15-ES
(EUCTR)

21/10/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

107

EUCTR2018-004002-25-BE
(EUCTR)

21/10/2019

10/09/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Taiwan;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

108

EUCTR2018-004002-25-FR
(EUCTR)

15/10/2019

14/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 2;Phase 3

United States;Portugal;Taiwan;Hong Kong;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Japan;Sweden

109

EUCTR2018-004002-25-SE
(EUCTR)

15/10/2019

03/07/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

United States;Portugal;Hong Kong;Taiwan;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

110

EUCTR2018-003985-15-PT
(EUCTR)

14/10/2019

10/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;United States;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

111

EUCTR2018-003986-33-BE
(EUCTR)

14/10/2019

15/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany

112

EUCTR2018-004002-25-GB
(EUCTR)

09/10/2019

20/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

950

Phase 2;Phase 3

113

EUCTR2018-001605-93-BG
(EUCTR)

09/10/2019

20/09/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan

114

EUCTR2018-005086-39-PL
(EUCTR)

07/10/2019

06/05/2019

A Study to Evaluate Efficacy and Safety of BT-11 product oral tablets in Mild to Moderate Ulcerative Colitis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Landos Biopharma Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

195

Phase 2

United States;Serbia;Belarus;Hungary;Poland;Ukraine;Croatia;Russian Federation;Georgia;Moldova, Republic of;Bosnia and Herzegovina

115

EUCTR2017-004230-28-CZ
(EUCTR)

04/10/2019

11/07/2019

BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

116

EUCTR2018-003986-33-NL
(EUCTR)

03/10/2019

22/08/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

Portugal;United States;Belarus;Serbia;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Lebanon;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

117

EUCTR2018-004002-25-HU
(EUCTR)

01/10/2019

13/08/2019

A Study of the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1000

Phase 2;Phase 3

Portugal;United States;Taiwan;Hong Kong;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Bulgaria;Germany;Japan;Sweden

118

NCT04006977
(ClinicalTrials.gov)

October 2019

1/7/2019

Multistrain Probiotics Reduces UC Depression and Anxiety Scores

Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis

Ulcerative Colitis

Dietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: Placebo

Xijing Hospital of Digestive Diseases

MENDES SA

Not yet recruiting

18 Years

65 Years

All

N/A

China

119

EUCTR2018-003985-15-DK
(EUCTR)

27/09/2019

24/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

120

EUCTR2018-003985-15-BG
(EUCTR)

27/09/2019

12/08/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

121

NCT04033445
(ClinicalTrials.gov)

September 26, 2019

24/7/2019

A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Placebo;Drug: Guselkumab

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

N/A

All

950

Phase 2;Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Latvia;Malaysia;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Serbia;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;Romania

122

EUCTR2018-003278-28-CZ
(EUCTR)

25/09/2019

15/04/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Estonia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

123

EUCTR2018-004694-27-DE
(EUCTR)

24/09/2019

24/05/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Czechia;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of

124

EUCTR2018-001605-93-BE
(EUCTR)

23/09/2019

07/06/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan;United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of

125

NCT03847467
(ClinicalTrials.gov)

September 20, 2019

12/2/2019

Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Drug: 2'-Fucosyllactose;Other: Placebo

Children's Hospital Medical Center, Cincinnati

Broad Institute;University of Cincinnati;Connecticut Children's Medical Center

Recruiting

11 Years

25 Years

All

216

Phase 1;Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

126

EUCTR2018-003985-15-NL
(EUCTR)

18/09/2019

09/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;Portugal;United States;Belarus;Estonia;Taiwan;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

127

EUCTR2018-001605-93-FR
(EUCTR)

13/09/2019

25/06/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 2

128

NCT04176588
(ClinicalTrials.gov)

September 10, 2019

22/11/2019

A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Etrasimod for Induction and Maintenance Treatment in Subjects With Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

Drug: Etrasimod;Drug: Placebo

Everstar Therapeutics Limited

NULL

Recruiting

18 Years

75 Years

All

333

Phase 3

China

129

EUCTR2018-002136-24-FR
(EUCTR)

10/09/2019

19/12/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany

130

EUCTR2017-004230-28-HU
(EUCTR)

06/09/2019

08/07/2019

BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis

Product Name: spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

Spain;Austria;Russian Federation;Israel;United Kingdom;Italy;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of;United States;Taiwan;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

131

EUCTR2016-000642-62-HR
(EUCTR)

30/08/2019

20/01/2020

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Belarus;United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

132

EUCTR2018-003558-26-BE
(EUCTR)

29/08/2019

27/05/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

United States;Belarus;Serbia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

133

EUCTR2018-003985-15-LT
(EUCTR)

27/08/2019

10/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

134

EUCTR2018-003985-15-EE
(EUCTR)

26/08/2019

15/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan

135

EUCTR2018-004491-35-PL
(EUCTR)

19/08/2019

03/07/2019

A study evaluating safety and efficacy of Itacitinib as treatment of moderate to severe ulcerative Colitis

A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Incyte Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

206

Phase 2

United States;Czech Republic;Poland;Romania;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

136

NCT03861143
(ClinicalTrials.gov)

August 14, 2019

27/2/2019

Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: Placebo

Landos Biopharma Inc.

NULL

Active, not recruiting

18 Years

65 Years

All

198

Phase 2

United States;Bosnia and Herzegovina;Croatia;Poland;Ukraine;Belarus;Georgia;Hungary;Moldova, Republic of;Russian Federation;Serbia

137

EUCTR2018-003985-15-HR
(EUCTR)

14/08/2019

24/12/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey

138

EUCTR2018-004694-27-CZ
(EUCTR)

13/08/2019

19/07/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Poland;Belgium;Australia;Russian Federation;Germany;Japan;Italy;United Kingdom;Korea, Republic of

139

NCT03977480
(ClinicalTrials.gov)

August 13, 2019

27/4/2019

Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Hemay007;Drug: Placebo

Tianjin Hemay Pharmaceutical Co.,Ltd

NULL

Recruiting

18 Years

70 Years

All

288

Phase 2

China

140

NCT03869905
(ClinicalTrials.gov)

August 8, 2019

8/3/2019

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Mild Ulcerative Colitis and Ulcerative Colitis in Remission

Ulcerative Colitis

Drug: Aquamin®;Drug: Placebo first then Aquamin®

James Varani

NULL

Recruiting

18 Years

80 Years

All

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

141

EUCTR2018-001605-93-ES
(EUCTR)

07/08/2019

09/08/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Allergan Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 2

142

EUCTR2018-003278-28-PL
(EUCTR)

03/08/2019

11/06/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Estonia;Slovakia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Japan;Korea, Republic of

143

ChiCTR1900024086

2019-08-01

2019-06-24

Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials

Ulcerative Colitis

intervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo;

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

NULL

Pending

Both

intervention period:10;control period:10;

N/A

China

144

NCT04029649
(ClinicalTrials.gov)

August 2019

17/7/2019

Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis

The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial

Ulcerative Colitis

Drug: Beta-1,3/1,6-D-Glucan;Drug: Placebo

Fakultas Kedokteran Universitas Indonesia

NULL

Not yet recruiting

18 Years

N/A

All

204

Phase 2;Phase 3

Indonesia

145

NCT03948919
(ClinicalTrials.gov)

July 31, 2019

10/5/2019

Low Sulfur Fecal Transplant for Ulcerative Colitis

Ulcerative Colitis

Drug: Fecal microbiota;Other: Placebo

University of Minnesota

NULL

Recruiting

18 Years

89 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

146

EUCTR2016-004676-22-BG
(EUCTR)

30/07/2019

14/05/2019

Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065.

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

147

EUCTR2016-000642-62-PT
(EUCTR)

29/07/2019

16/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;United States;Belarus;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Croatia;Germany;Norway;Japan;Sweden

148

EUCTR2018-003985-15-HU
(EUCTR)

29/07/2019

16/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

149

EUCTR2016-000642-62-GB
(EUCTR)

26/07/2019

25/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

150

EUCTR2018-004694-27-GB
(EUCTR)

23/07/2019

30/04/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Australia;Germany;Japan;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

151

EUCTR2018-003349-41-FR
(EUCTR)

11/07/2019

27/05/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Belarus;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany

152

EUCTR2018-003985-15-LV
(EUCTR)

05/07/2019

02/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

153

EUCTR2018-001605-93-GB
(EUCTR)

01/07/2019

04/04/2019

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 2

United States;Taiwan;Spain;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Japan

154

EUCTR2017-004230-28-GR
(EUCTR)

01/07/2019

03/05/2019

BI 655130 induction treatment in patients with moderate-to severe ulcerative colitis

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Boehringer Ingelheim International GmbH

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

155

EUCTR2018-003986-33-SK
(EUCTR)

01/07/2019

02/05/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

156

EUCTR2018-004694-27-PL
(EUCTR)

30/06/2019

15/05/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Germany;Japan;Korea, Republic of

157

EUCTR2018-004694-27-HU
(EUCTR)

25/06/2019

06/05/2019

Safety and Efficacy of BMS-986165 Compared with Placebo in Subjects with Ulcerative Colitis

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165
Other descriptive name: BMS986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

United States;Spain;Russian Federation;Switzerland;United Kingdom;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Germany;Japan;Korea, Republic of

158

EUCTR2018-002136-24-DE
(EUCTR)

25/06/2019

27/12/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060
Product Name: TD-1473
Product Code: TD-1473
INN or Proposed INN: Not assigned
Other descriptive name: THRX-139060

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

159

EUCTR2016-004677-40-BG
(EUCTR)

25/06/2019

18/04/2019

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

160

NCT03923478
(ClinicalTrials.gov)

June 24, 2019

15/4/2019

ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment

Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate

Drug: ABI-M201;Drug: Placebo

Assembly Biosciences

NULL

Recruiting

18 Years

70 Years

All

Phase 1

United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

161

EUCTR2018-003985-15-SK
(EUCTR)

21/06/2019

16/04/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

372

Phase 3

Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand

162

EUCTR2016-000642-62-GR
(EUCTR)

21/06/2019

25/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

163

EUCTR2016-000642-62-IE
(EUCTR)

18/06/2019

26/11/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

164

NCT03483246
(ClinicalTrials.gov)

June 18, 2019

26/2/2018

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

Ulcerative Colitis

Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation Placebo

Assistance Publique - Hôpitaux de Paris

CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France

Recruiting

18 Years

75 Years

All

150

Phase 3

France

165

EUCTR2017-004230-28-DK
(EUCTR)

14/06/2019

24/03/2019

BI655130 (SPESOLIMAB) induction treatment in patients with moderate-to-severe ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Boehringer Ingelheim Denmark A/S

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Denmark;Australia;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

166

NCT03945188
(ClinicalTrials.gov)

June 13, 2019

8/5/2019

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Etrasimod;Drug: Placebo

Arena Pharmaceuticals

NULL

Recruiting

16 Years

80 Years

All

372

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Denmark;Estonia;France;Georgia;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Latvia;Lebanon;Lithuania;Mexico;Moldova, Republic of;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom

167

EUCTR2016-000642-62-NL
(EUCTR)

13/06/2019

11/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

168

EUCTR2018-003558-26-SI
(EUCTR)

12/06/2019

07/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

United States;Belarus;Serbia;Slovenia;Slovakia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Germany

169

EUCTR2018-002136-24-BG
(EUCTR)

12/06/2019

18/01/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

Serbia;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

170

NCT03760003
(ClinicalTrials.gov)

June 11, 2019

29/11/2018

Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment

Ulcerative Colitis

Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo

Abivax S.A.

NULL

Recruiting

18 Years

75 Years

All

232

Phase 2

United States;Austria;Belarus;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Serbia;Slovakia;Slovenia;Spain;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

171

NCT03915769
(ClinicalTrials.gov)

June 3, 2019

12/4/2019

To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Ozanimod;Other: Placebo

Celgene

NULL

Recruiting

18 Years

75 Years

All

195

Phase 3

Japan

172

EUCTR2013-004279-11-FR
(EUCTR)

03/06/2019

09/04/2019

A study of the effectiveness (efficacy) and safety of etrolizumab treatment, compared with Adalimumab and Placebo, in inducing disease remission in ulcerative colitis patients who have not previously received TNF inhibitors

PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS I

Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

173

NCT03941418
(ClinicalTrials.gov)

June 1, 2019

5/5/2019

Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease

Ulcerative Colitis;Crohn Disease

Dietary Supplement: Boulardii;Dietary Supplement: Placebo

University Clinic Dr Dragisa Misovic-Dedinje

University Clinic Zvezdara

Not yet recruiting

18 Years

80 Years

All

150

N/A

NULL

174

EUCTR2018-003349-41-BG
(EUCTR)

29/05/2019

27/02/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany

175

EUCTR2018-000930-37-ES
(EUCTR)

27/05/2019

22/01/2019

A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

France;United States;Canada;Spain;Netherlands;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

176

EUCTR2018-002136-24-ES
(EUCTR)

23/05/2019

11/04/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;South Africa;Bulgaria;Georgia;Germany

177

EUCTR2018-003558-26-SK
(EUCTR)

23/05/2019

20/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Czech Republic;United States;Belarus;Serbia;Slovakia;Hungary;Canada;Belgium;Poland;Germany

178

EUCTR2018-003558-26-HU
(EUCTR)

21/05/2019

25/03/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

232

Phase 2

United States;Belarus;Serbia;Czechia;Slovakia;Slovenia;Spain;Ukraine;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Germany

179

EUCTR2018-003558-26-PL
(EUCTR)

20/05/2019

12/04/2019

Investigate the safety and efficacy of study drug ABX464 compared with placebo in patients with moderate to severe ulcerative colitis who have failed to other treatments.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464
Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

244

Phase 2

Serbia;United States;Belarus;Slovakia;Slovenia;Spain;Ukraine;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Germany

180

EUCTR2016-004676-22-SI
(EUCTR)

20/05/2019

06/02/2019

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Bulgaria;Germany;New Zealand;Japan;Sweden;Romania;Croatia;United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

181

EUCTR2016-004677-40-SI
(EUCTR)

20/05/2019

06/02/2019

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

182

NCT03943550
(ClinicalTrials.gov)

May 14, 2019

7/5/2019

Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis

Ulcerative Colitis

Drug: RO7049665;Drug: Placebo

Hoffmann-La Roche

NULL

Recruiting

18 Years

70 Years

All

Phase 1

United States;Georgia;Hungary;Moldova, Republic of;Ukraine

183

EUCTR2018-000930-37-FR
(EUCTR)

07/05/2019

07/12/2018

A Study to Investigate safety and how well ABBV-323 works and how safe it is in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;France;Canada;Spain;Netherlands;Germany;Italy;United Kingdom

184

EUCTR2018-003278-28-FR
(EUCTR)

07/05/2019

09/05/2019

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

Serbia;United States;Estonia;Slovakia;Slovenia;Ukraine;Lithuania;Russian Federation;United Kingdom;India;France;Czech Republic;Hungary;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

185

NCT03893565
(ClinicalTrials.gov)

May 6, 2019

26/3/2019

Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis

A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis

Colitis, Ulcerative

Drug: GSK2831781 IV infusion;Drug: GSK2831781 SC injection;Drug: Placebo IV infusion;Drug: Placebo SC injection

GlaxoSmithKline

NULL

Recruiting

18 Years

N/A

All

242

Phase 2

United States;Belgium;Bulgaria;Canada;Czechia;Estonia;France;India;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Serbia;Slovakia;South Africa;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

186

NCT03934216
(ClinicalTrials.gov)

May 3, 2019

30/4/2019

Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis (UC)

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: BMS-986165;Drug: Placebo

Bristol-Myers Squibb

NULL

Recruiting

18 Years

80 Years

All

120

Phase 2

United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom

187

NCT03843385
(ClinicalTrials.gov)

May 2019

14/2/2019

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis

Ulcerative Colitis;Inflammatory Bowel Diseases

Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo

Jena University Hospital

German Federal Ministry of Education and Research

Not yet recruiting

18 Years

75 Years

All

174

Phase 2;Phase 3

NULL

188

EUCTR2018-003278-28-GB
(EUCTR)

29/04/2019

14/12/2018

Safety, tolerability, efficacy and dose-response of GSK2831781 in ulcerative colitis.

Product Code: GSK2831781
INN or Proposed INN: Not Assigned
Other descriptive name: GSK2831781

GlaxoSmithKline Research & Development Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Estonia;Slovenia;Slovakia;Ukraine;Lithuania;Russian Federation;Israel;United Kingdom;India;France;Czech Republic;Hungary;Mexico;Canada;Poland;South Africa;Bulgaria;Netherlands;Korea, Republic of

189

EUCTR2017-003703-22-PL
(EUCTR)

25/04/2019

26/04/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

190

NCT03860896
(ClinicalTrials.gov)

April 24, 2019

14/2/2019

GB004 in Adult Subjects With Active Ulcerative Colitis

A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: GB004;Drug: Placebo

GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

NULL

Completed

18 Years

74 Years

All

Phase 1

United States;Georgia;Moldova, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

191

NCT03800420
(ClinicalTrials.gov)

April 22, 2019

7/1/2019

Efficacy and Safety of BBT-401-1S in Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Active group;Drug: Placebo group

Bridge Biotherapeutics, Inc.

KCRN Research, LLC

Terminated

18 Years

N/A

All

Phase 2

United States

192

NCT03675477
(ClinicalTrials.gov)

April 13, 2019

16/9/2018

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis.

Ulcerative Colitis

Drug: SHR0302;Drug: Placebos

Reistone Biopharma Company Limited

NULL

Active, not recruiting

18 Years

75 Years

All

164

Phase 2

United States;China;Poland;Puerto Rico;Ukraine

193

EUCTR2013-004277-27-HU
(EUCTR)

11/04/2019

25/02/2019

PHASE III, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBOCONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (INDUCTION OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH ADALIMUMAB AND PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - HIBISCUS II

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Hungary;Czech Republic;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

194

EUCTR2018-002136-24-PL
(EUCTR)

04/04/2019

18/01/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

United States;Portugal;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Australia;South Africa;Korea, Republic of;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan

195

EUCTR2018-002136-24-GR
(EUCTR)

03/04/2019

18/02/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Moderately-to-Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Theravance Biopharma Ireland Limited

NULL

Not Recruiting

Female: yes
Male: yes

880

Phase 2;Phase 3

Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

196

NCT03794765
(ClinicalTrials.gov)

April 1, 2019

4/1/2019

Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis

Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial

Ulcerative Colitis;Inflammatory Bowel Diseases;Acute Severe Colitis

Drug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusion

Postgraduate Institute of Medical Education and Research

NULL

Completed

13 Years

N/A

All

Phase 2

India

197

NCT04000139
(ClinicalTrials.gov)

April 1, 2019

24/6/2019

Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative Colitis

A Multi-center, Multi-national, Randomized, Double-blind, Placebo Controlled, Parallel Group, Phase IIa Study to Evaluate the Efficacy, Safety and Tolerability of an Anthocyanin-rich Extract (ACRE) in Patients With Ulcerative Colitis

Ulcerative Colitis

Drug: Standardized anthocyanin-rich extract;Drug: Placebo

University of Zurich

Swiss National Science Foundation;The Broad Foundation

Recruiting

18 Years

N/A

All

120

Phase 2

Switzerland

198

NCT04224857
(ClinicalTrials.gov)

April 1, 2019

23/5/2019

SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101

Ulcerative Colitis

Drug: AMT -101;Drug: Placebos

Applied Molecular Transport

NULL

Completed

18 Years

N/A

All

Phase 1

Georgia;Germany;Moldova, Republic of;Ukraine

199

EUCTR2018-003349-41-GB
(EUCTR)

28/03/2019

21/12/2018

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Product Name: ST-0529
Product Code: FP-CYA-050
INN or Proposed INN: CICLOSPORIN
Other descriptive name: cyclosporine

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

380

Phase 2

Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany

200

EUCTR2016-000642-62-LT
(EUCTR)

19/03/2019

15/11/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

201

EUCTR2018-002136-24-PT
(EUCTR)

18/03/2019

02/01/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

202

EUCTR2013-004277-27-CZ
(EUCTR)

18/03/2019

29/03/2019

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Lithuania;Turkey;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Malaysia;Brazil;Croatia;Australia;Bulgaria;Latvia;New Zealand

203

NCT03768219
(ClinicalTrials.gov)

March 18, 2019

30/11/2018

Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis

Psoriasis;Ulcerative Colitis

Biological: APVO210;Biological: Placebo

Aptevo Therapeutics

NULL

Active, not recruiting

18 Years

65 Years

All

144

Phase 1

Australia

204

EUCTR2018-003364-31-PL
(EUCTR)

15/03/2019

23/01/2019

A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis.

A Phase II randomized, placebo controlled, double-blind, 4 arms dose-ranging study to evaluate the efficacy and safety of SHR0302 compared to placebo in patients with moderate to severe active Ulcerative Colitis.

Product Code: SHR0302
INN or Proposed INN: Pending

Reistone Biopharma Company Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

152

Phase 2

United States;Poland;Ukraine;China

205

EUCTR2016-000642-62-PL
(EUCTR)

14/03/2019

12/06/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

206

NCT03758443
(ClinicalTrials.gov)

March 11, 2019

19/11/2018

Efficacy & Safety of TD-1473 in Ulcerative Colitis

A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C;Drug: Placebo

Theravance Biopharma

NULL

Recruiting

18 Years

N/A

All

880

Phase 2;Phase 3

United States;Australia;Bulgaria;Canada;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Poland;Portugal;Romania;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine

207

EUCTR2018-003349-41-PL
(EUCTR)

27/02/2019

15/01/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany

208

EUCTR2018-002136-24-SK
(EUCTR)

19/02/2019

28/12/2018

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

209

EUCTR2018-003349-41-HU
(EUCTR)

19/02/2019

08/01/2019

Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis

Active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Sublimity Therapeutics (Hold Co) Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Belarus;Spain;Ukraine;Ireland;Turkey;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany

210

EUCTR2018-002136-24-HU
(EUCTR)

18/02/2019

29/03/2019

A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis

Theravance Biopharma Ireland Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

880

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

211

EUCTR2017-003229-14-HR
(EUCTR)

08/02/2019

16/05/2019

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

212

EUCTR2017-003238-96-HR
(EUCTR)

08/02/2019

17/05/2019

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

213

NCT03832400
(ClinicalTrials.gov)

February 4, 2019

21/11/2018

Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC)

A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative Colitis

Ulcerative Colitis

Biological: MET-2;Drug: Placebo oral capsule

NuBiyota

NULL

Active, not recruiting

18 Years

N/A

All

Phase 1

Canada

214

EUCTR2016-004676-22-HR
(EUCTR)

01/02/2019

16/05/2019

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

215

EUCTR2016-004677-40-HR
(EUCTR)

31/01/2019

16/05/2019

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

216

EUCTR2016-000642-62-SK
(EUCTR)

28/01/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

217

NCT03844932
(ClinicalTrials.gov)

January 24, 2019

31/1/2019

A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: ST-0529

Sublimity Therapeutics Holdco Limited

Dr. Falk Pharma GmbH

Recruiting

18 Years

75 Years

All

280

Phase 2

United States;Belarus;Bulgaria;Canada;France;Germany;Hungary;Ireland;Israel;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom

218

EUCTR2016-004676-22-DE
(EUCTR)

22/01/2019

15/06/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

219

EUCTR2016-000642-62-ES
(EUCTR)

17/01/2019

24/01/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan

220

EUCTR2016-000642-62-CZ
(EUCTR)

14/01/2019

14/11/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

221

EUCTR2016-004676-22-BE
(EUCTR)

14/01/2019

04/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

222

EUCTR2016-000642-62-AT
(EUCTR)

02/01/2019

30/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

522

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

223

EUCTR2016-004676-22-GB
(EUCTR)

20/12/2018

03/07/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safetyof Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

224

EUCTR2016-000642-62-HU
(EUCTR)

19/12/2018

08/01/2019

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan

225

NCT03759041
(ClinicalTrials.gov)

December 19, 2018

27/11/2018

A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Vancomycin Pre-Treatment;Drug: Placebo for Vancomycin Pre-Treatment;Drug: SER-287;Drug: Placebo for SER-287

Seres Therapeutics, Inc.

NULL

Recruiting

18 Years

80 Years

All

201

Phase 2

United States;Canada

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

226

JPRN-JapicCTI-184131

18/12/2018

28/09/2018

A Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis [M14-675]

Ulcerative Colitis

Intervention name : ABT-494
INN of the intervention : upadacitinib
Dosage And administration of the intervention : Will be orally administered
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Will be orally administered

AbbVie GK

NULL

recruiting

BOTH

Phase 3

Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa, -

227

EUCTR2016-000642-62-LV
(EUCTR)

13/12/2018

15/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

462

Phase 3

Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan

228

EUCTR2017-002350-36-GB
(EUCTR)

10/12/2018

13/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10075635;Term: Acute hemorrhagic ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: n.a.
Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

229

NCT03574948
(ClinicalTrials.gov)

December 6, 2018

22/6/2018

5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores

Multicentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue Scores

Crohn Disease;Ulcerative Colitis;Fatigue;Remission

Drug: 5-HTP;Drug: Placebo oral capsule

University Hospital, Ghent

NULL

Recruiting

18 Years

60 Years

All

180

Phase 2

Belgium

230

EUCTR2016-004677-40-DE
(EUCTR)

04/12/2018

26/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjectswith Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled InductionStudy to Evaluate the Efficacy and Safety of Risankizumab in Subjects withModerately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

231

NCT03716388
(ClinicalTrials.gov)

December 1, 2018

21/10/2018

Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC

Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study

Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate

Biological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granules

Dayanand Medical College and Hospital

Colitis & Crohn's Foundation (India)

Recruiting

18 Years

75 Years

All

Phase 3

India

232

NCT02201758
(ClinicalTrials.gov)

December 2018

18/7/2014

Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment

Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment.

Ulcerative Colitis

Dietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: Placebo

University of Saskatchewan

Royal University Hospital Foundation

Unknown status

18 Years

N/A

All

Phase 2

Canada

233

EUCTR2016-004677-40-BE
(EUCTR)

29/11/2018

04/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Turkey

234

EUCTR2017-003229-14-DK
(EUCTR)

20/11/2018

11/10/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly Cork Limited

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

235

NCT03662542
(ClinicalTrials.gov)

November 20, 2018

6/9/2018

A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo

Janssen Research & Development, LLC

NULL

Recruiting

18 Years

65 Years

All

210

Phase 2

United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

236

EUCTR2017-003238-96-DK
(EUCTR)

20/11/2018

09/10/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

237

EUCTR2016-004676-22-DK
(EUCTR)

15/11/2018

02/05/2018

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

238

EUCTR2016-000642-62-FI
(EUCTR)

13/11/2018

16/10/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

462

Phase 3

Portugal;United States;Belarus;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Germany;Norway;Japan;Sweden

239

NCT03653026
(ClinicalTrials.gov)

November 12, 2018

28/8/2018

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: Upadacitinib (ABT-494);Drug: Placebo

AbbVie

NULL

Active, not recruiting

16 Years

75 Years

All

523

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Egypt;Romania;Sweden

240

NCT03558152
(ClinicalTrials.gov)

October 26, 2018

1/6/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC)

A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: UTTR1147A;Drug: UTTR1147A Placebo;Drug: Vedolizumab;Drug: Vedolizumab Placebo

Genentech, Inc.

NULL

Recruiting

18 Years

80 Years

All

270

Phase 2

United States;Bulgaria;Georgia;Germany;Greece;Hungary;Ireland;Israel;Italy;Moldova, Republic of;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;China;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

241

EUCTR2016-004677-40-GR
(EUCTR)

26/10/2018

04/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

720

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

242

EUCTR2016-004676-22-GR
(EUCTR)

26/10/2018

04/06/2018

A Study of Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

243

EUCTR2017-003229-14-GB
(EUCTR)

24/10/2018

04/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

244

EUCTR2017-003238-96-AT
(EUCTR)

24/10/2018

22/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

245

EUCTR2017-003229-14-AT
(EUCTR)

24/10/2018

22/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

246

EUCTR2017-003238-96-GB
(EUCTR)

22/10/2018

04/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

247

EUCTR2017-000402-38-SE
(EUCTR)

19/10/2018

25/05/2018

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis

To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: no
Male: yes

250

Phase 2

United States;Portugal;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;United Kingdom;Italy;India;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

248

NCT03524092
(ClinicalTrials.gov)

October 19, 2018

10/5/2018

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

Ulcerative Colitis

Drug: Mirikizumab;Drug: Placebo

Eli Lilly and Company

NULL

Recruiting

18 Years

80 Years

All

1044

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil

249

EUCTR2017-003229-14-DE
(EUCTR)

15/10/2018

30/04/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania

250

EUCTR2017-003238-96-DE
(EUCTR)

15/10/2018

03/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB
Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

251

EUCTR2017-002350-36-GR
(EUCTR)

03/10/2018

10/09/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

252

EUCTR2016-004676-22-SE
(EUCTR)

02/10/2018

16/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

253

EUCTR2016-004677-40-SE
(EUCTR)

02/10/2018

16/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

254

EUCTR2017-003238-96-HU
(EUCTR)

27/09/2018

13/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan

255

EUCTR2017-002350-36-DE
(EUCTR)

27/09/2018

13/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

256

EUCTR2017-003229-14-HU
(EUCTR)

27/09/2018

15/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

257

EUCTR2016-004677-40-NL
(EUCTR)

26/09/2018

24/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;Czech Republic;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

258

EUCTR2016-004676-22-NL
(EUCTR)

26/09/2018

02/05/2018

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Latvia;Netherlands

259

NCT03627052
(ClinicalTrials.gov)

September 20, 2018

8/8/2018

A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis

Drug: Itacitinib;Drug: Placebo

Incyte Corporation

NULL

Withdrawn

18 Years

74 Years

All

Phase 2

United States

260

EUCTR2017-003229-14-SK
(EUCTR)

06/09/2018

06/07/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

261

EUCTR2017-003238-96-SK
(EUCTR)

04/09/2018

20/07/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

262

EUCTR2017-004230-28-NL
(EUCTR)

30/08/2018

15/03/2018

BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim bv

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Korea, Republic of

263

EUCTR2016-004676-22-LV
(EUCTR)

30/08/2018

29/08/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Korea, Republic of;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

264

EUCTR2017-003238-96-LV
(EUCTR)

30/08/2018

21/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

265

EUCTR2017-002350-36-NL
(EUCTR)

28/08/2018

24/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Product Code: UTTR1147A/RO7021610 (Active)
INN or Proposed INN: n.a.
Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc
Trade Name: Entyvio 300mg
Product Code: RO7246311
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

266

NCT03398135
(ClinicalTrials.gov)

August 28, 2018

8/1/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: risankizumab;Drug: placebo for risankizumab

AbbVie

NULL

Enrolling by invitation

16 Years

80 Years

All

760

Phase 3

United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Czechia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Hungary

267

JPRN-JapicCTI-184008

28/8/2018

21/06/2018

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 [M16-066]

Ulcerative Colitis (UC)

Intervention name : Risankizumab (Genetical Recombination)
INN of the intervention : risankizumab
Dosage And administration of the intervention : SC/IV
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

AbbVie GK

NULL

recruiting

BOTH

Phase 3

Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa

268

EUCTR2017-002350-36-IE
(EUCTR)

28/08/2018

16/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

269

EUCTR2017-000573-37-EE
(EUCTR)

27/08/2018

11/06/2018

Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303).

A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

270

EUCTR2016-004677-40-LT
(EUCTR)

23/08/2018

13/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

271

EUCTR2016-004676-22-LT
(EUCTR)

23/08/2018

26/06/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

272

EUCTR2017-002350-36-BG
(EUCTR)

22/08/2018

28/05/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Bulgaria;Netherlands;Germany

273

EUCTR2017-003229-14-CZ
(EUCTR)

16/08/2018

30/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

France;Malaysia;Denmark;Australia;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan;United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India

274

EUCTR2017-003238-96-CZ
(EUCTR)

16/08/2018

30/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

275

EUCTR2016-004676-22-SK
(EUCTR)

14/08/2018

05/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Malaysia;Denmark;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

276

EUCTR2016-004677-40-SK
(EUCTR)

14/08/2018

05/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

277

NCT03616821
(ClinicalTrials.gov)

August 7, 2018

1/8/2018

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION]

A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Colitis;Ulcerative;IBD

Drug: Brazikumab;Drug: Vedolizumab;Drug: Placebo

Allergan

NULL

Recruiting

18 Years

80 Years

All

375

Phase 2

United States;Canada;Puerto Rico

278

EUCTR2017-003229-14-LV
(EUCTR)

03/08/2018

21/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

279

EUCTR2016-004677-40-LV
(EUCTR)

03/08/2018

27/07/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

280

EUCTR2017-003238-96-ES
(EUCTR)

01/08/2018

04/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

281

EUCTR2017-003238-96-BE
(EUCTR)

27/07/2018

07/06/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Moderately to Severely Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

282

EUCTR2017-003229-14-BE
(EUCTR)

27/07/2018

08/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

283

EUCTR2017-002108-28-DE
(EUCTR)

25/07/2018

27/03/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) - BUILD UC

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: PF-06687234
Other descriptive name: F8IL10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of

284

EUCTR2017-000402-38-BE
(EUCTR)

25/07/2018

30/05/2018

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Poland;Belgium;Australia;Netherlands;Germany;New Zealand;Sweden

285

EUCTR2017-003229-14-ES
(EUCTR)

24/07/2018

04/06/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

286

EUCTR2017-003238-96-NL
(EUCTR)

24/07/2018

14/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan

287

EUCTR2017-003703-22-NL
(EUCTR)

24/07/2018

05/03/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2

Serbia;United States;Czech Republic;Poland;Belgium;Spain;Ukraine;Russian Federation;Germany;Netherlands;United Kingdom

288

EUCTR2015-000319-41-GR
(EUCTR)

23/07/2018

18/04/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Inductionand Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 0.25 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Product Name: 1.0 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

289

EUCTR2016-004676-22-PT
(EUCTR)

16/07/2018

02/07/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction treatment in M16-067 or M16-065”

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

290

EUCTR2016-004677-40-PT
(EUCTR)

16/07/2018

01/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

291

EUCTR2017-000402-38-ES
(EUCTR)

13/07/2018

25/07/2018

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Netherlands;Germany;New Zealand;Sweden

292

EUCTR2015-000319-41-ES
(EUCTR)

12/07/2018

21/05/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Product Name: 1.0 mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

293

NCT03860571
(ClinicalTrials.gov)

July 6, 2018

3/2/2019

Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers

Ulcerative Colitis;Crohn Disease

Drug: BT-11 Placebo;Drug: BT-11 Active

Landos Biopharma Inc.

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

294

EUCTR2017-003229-14-LT
(EUCTR)

05/07/2018

31/05/2018

AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Product Name: mirikizumab
Product Code: LY3074828
INN or Proposed INN: MIRIKIZUMAB
Other descriptive name: MIRIKIZUMAB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1160

Phase 3

295

EUCTR2017-003238-96-LT
(EUCTR)

05/07/2018

31/05/2018

A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1044

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

296

NCT03773952
(ClinicalTrials.gov)

July 1, 2018

30/11/2018

Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients

A Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: PBF-677;Drug: Placebo oral capsule

Palobiofarma SL

Qualitecfarma

Recruiting

18 Years

75 Years

All

Phase 2

Spain

297

EUCTR2016-004677-40-DK
(EUCTR)

28/06/2018

12/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

298

EUCTR2016-004677-40-AT
(EUCTR)

25/06/2018

06/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1547

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

299

EUCTR2016-004676-22-AT
(EUCTR)

25/06/2018

06/04/2018

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

942

Phase 3

United States;Serbia;Portugal;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

300

EUCTR2015-000319-41-LV
(EUCTR)

22/06/2018

13/04/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Product Name: 0.25mg RPC103
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride
Product Name: 1.0 mg RPC103
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

301

EUCTR2016-004677-40-ES
(EUCTR)

21/06/2018

17/04/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

720

Phase 2;Phase 3

302

EUCTR2017-002350-36-HU
(EUCTR)

14/06/2018

19/04/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

270

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

303

EUCTR2017-000572-28-BE
(EUCTR)

08/06/2018

14/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina

304

NCT03531892
(ClinicalTrials.gov)

June 6, 2018

9/5/2018

A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis

Phase III Study of AJM300 in Patients With Active Ulcerative Colitis

Colitis, Ulcerative

Drug: AJM300;Drug: Placebo

EA Pharma Co., Ltd.

Kissei Pharmaceutical Co., Ltd.

Recruiting

16 Years

74 Years

All

198

Phase 3

Japan

305

EUCTR2016-004676-22-ES
(EUCTR)

05/06/2018

13/04/2018

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

760

Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

306

EUCTR2017-004230-28-DE
(EUCTR)

04/06/2018

31/01/2018

BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: SPESOLIMAB
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Pharma GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

307

JPRN-JapicCTI-183997

29/5/2018

12/06/2018

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067]

Ulcerative Colitis (UC)

AbbVie GK

NULL

recruiting

BOTH

Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa

308

EUCTR2017-003228-54-ES
(EUCTR)

28/05/2018

09/04/2018

A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.

A Phase IIa (proof of concept), randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis.

Inflammatory Bowel disease, mild to moderate Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PBF-677
INN or Proposed INN: PBF-677

PaloBiofarma S.L.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain

309

EUCTR2015-000319-41-AT
(EUCTR)

25/05/2018

17/04/2018

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

310

EUCTR2017-000402-38-NL
(EUCTR)

24/05/2018

13/11/2017

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Netherlands;Germany;New Zealand;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

311

EUCTR2017-004230-28-IT
(EUCTR)

22/05/2018

05/11/2020

BI 655130 induction treatment in patients with moderate-tosevereulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Evaluate the Safety and Efficacy of BI 655130 Induction Therapyin patients with moderate-to-severely active ulcerative colitis who havefailed previous biologics therapy - -

Moderate-to-severely active ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Product Name: -
Product Code: [BI 655130]
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

BOEHRINGER-INGELHEIM ITALIA S.P.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of

312

NCT03565939
(ClinicalTrials.gov)

May 4, 2018

22/5/2018

Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO)

Ulcerative Colitis Chronic Moderate

Biological: Trichuris suis ova;Biological: Placebo

ParaTech A/S

NULL

Recruiting

18 Years

75 Years

All

120

Phase 2

Denmark

313

EUCTR2017-003703-22-GB
(EUCTR)

03/05/2018

31/01/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838
Product Name: vidofludimus calcium
Product Code: IMU-838
INN or Proposed INN: Vidofludimus calcium dihydrate
Other descriptive name: IM90838

Immunic AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

Serbia;Portugal;United States;Belarus;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Netherlands;Bosnia and Herzegovina

314

NCT03594708
(ClinicalTrials.gov)

April 30, 2018

19/1/2018

Immunonutrition in Ulcerative Colitis

Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients

Ulcerative Colitis

Dietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplement

Baptist Memorial Health Care Corporation

NULL

Unknown status

18 Years

N/A

All

N/A

United States

315

EUCTR2017-003703-22-ES
(EUCTR)

29/04/2018

20/02/2018

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1)

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Immunic AG

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

316

EUCTR2017-000573-37-HR
(EUCTR)

23/04/2018

07/12/2018

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

317

EUCTR2017-000599-27-HR
(EUCTR)

20/04/2018

07/12/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Serbia;Czechia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand

318

EUCTR2016-003708-29-BG
(EUCTR)

20/04/2018

17/01/2018

Study to evaluate the effectiveness of oral PF-06651600 and PF-06700841 in subjects with moderate to severe ulcerative colitis, a disease characterized by continuous inflammation that is localized to the colon

A Phase 2B, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Dose Ranging Study of Oral PF-06651600 and PF-06700841 as Induction and Chronic Therapy in Subjects with Moderate to Severe Ulcerative Colitis - Vibrato

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of

319

EUCTR2017-002350-36-ES
(EUCTR)

15/04/2018

06/06/2018

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis.

Roche Farma, S.A por delegación de Genentech, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

330

Phase 2

Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands

320

EUCTR2017-004230-28-GB
(EUCTR)

13/04/2018

01/02/2018

BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-tosevere ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1
Product Name: Spesolimab
Product Code: BI 655130
INN or Proposed INN: Spesolimab
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim Limited

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Japan;China;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

321

EUCTR2017-002108-28-ES
(EUCTR)

12/04/2018

20/04/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Dekavil
Product Code: PF-06687234
INN or Proposed INN: Dekavil
Other descriptive name: F8IL10

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Serbia;Saudi Arabia;Belgium;Spain;Australia;Israel;Germany;Italy;Korea, Republic of

322

EUCTR2017-000599-27-DE
(EUCTR)

10/04/2018

24/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Serbia;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Germany;Netherlands;Japan;New Zealand

323

EUCTR2017-000573-37-DE
(EUCTR)

10/04/2018

24/10/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

324

EUCTR2017-004230-28-ES
(EUCTR)

09/04/2018

08/02/2018

BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis

Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

Boehringer Ingelheim España, S.A.

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

United States;Taiwan;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Korea, Republic of

325

NCT03290781
(ClinicalTrials.gov)

April 4, 2018

6/9/2017

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

Ulcerative Colitis

Drug: Ontamalimab;Other: Placebo

Shire

NULL

Active, not recruiting

16 Years

81 Years

All

366

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Lebanon;Lithuania;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Turkey;Ukraine;United Kingdom;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

326

EUCTR2017-002108-28-BE
(EUCTR)

30/03/2018

22/03/2018

A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06687234/placebo as add-on therapy to infliximab in subjects with ulcerative colitis who are not in remission

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Serbia;United States;Saudi Arabia;Spain;Belgium;Australia;Israel;Germany;Italy;Korea, Republic of

327

EUCTR2016-000641-31-BE
(EUCTR)

29/03/2018

31/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494
Product Name: Upadacitinib
Product Code: ABT-494
INN or Proposed INN: Upadacitinib
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Belgium;Poland;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

328

NCT03482635
(ClinicalTrials.gov)

March 27, 2018

15/3/2018

BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI655130 (SPESOLIMAB) Induction Therapy in Patients With Moderate-to-severely Active Ulcerative Colitis Who Have Failed Previous Biologics Therapy

Colitis, Ulcerative

Drug: Spesolimab;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

75 Years

All

Phase 2;Phase 3

United States;Austria;Belgium;Canada;Germany;Greece;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;United Kingdom;Australia;Czechia;Denmark;Hungary;Norway

329

NCT03597971
(ClinicalTrials.gov)

March 20, 2018

3/5/2018

HMPL004-6599 Phase I Dose-escalating Study

A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers

Ulcerative Colitis;Crohn Disease

Drug: HMPL004-6599;Drug: Placebo

Nutrition Science Partners Limited

Hutchison Medipharma Limited;Nestlé

Terminated

18 Years

45 Years

Male

Phase 1

Australia

330

NCT03482648
(ClinicalTrials.gov)

March 20, 2018

17/3/2018

First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects

Ulcerative Colitis

Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo

Bridge Biotherapeutics, Inc.

KCRN Research, LLC

Completed

19 Years

55 Years

All

Phase 1

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

331

EUCTR2017-000573-37-NL
(EUCTR)

15/03/2018

02/11/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

332

NCT03518086
(ClinicalTrials.gov)

March 15, 2018

4/5/2018

An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

Ulcerative Colitis

Drug: Mirikizumab;Drug: Placebo

Eli Lilly and Company

NULL

Recruiting

18 Years

80 Years

All

1160

Phase 3

333

NCT03341962
(ClinicalTrials.gov)

March 15, 2018

8/11/2017

Phase 2 Dose-finding IMU-838 for Ulcerative Colitis

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis

Ulcerative Colitis

Drug: IMU-838;Drug: Placebo

Immunic AG

NULL

Recruiting

18 Years

80 Years

All

240

Phase 2

United States;Albania;Belarus;Bosnia and Herzegovina;Bulgaria;Croatia;Czechia;Georgia;Netherlands;North Macedonia;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;United Kingdom

334

EUCTR2017-000573-37-PT
(EUCTR)

13/03/2018

21/12/2017

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

335

EUCTR2017-000573-37-IE
(EUCTR)

13/03/2018

04/09/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

336

EUCTR2017-000572-28-PT
(EUCTR)

13/03/2018

22/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

337

EUCTR2017-004230-28-BE
(EUCTR)

09/03/2018

22/01/2018

BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis

Product Code: BI 655130
INN or Proposed INN: BI 655130
Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1

SCS Boehringer Ingelheim Comm. V

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

338

EUCTR2017-000599-27-GB
(EUCTR)

07/03/2018

05/12/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan

339

NCT03398148
(ClinicalTrials.gov)

March 7, 2018

8/1/2018

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: risankizumab IV;Drug: placebo for risankizumab;Drug: risankizumab SC

AbbVie

NULL

Recruiting

16 Years

80 Years

All

720

Phase 2;Phase 3

United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Czechia;Hungary

340

EUCTR2017-000573-37-GB
(EUCTR)

07/03/2018

25/09/2017

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

341

EUCTR2017-004230-28-AT
(EUCTR)

27/02/2018

18/01/2018

BI 655130 (SPESOLIMAB) induction treatment in patients with moderate-to severe ulcerative colitis

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 (SPESOLIMAB) Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

Boehringer Ingelheim RCV GmbH & Co KG

NULL

Not Recruiting

Female: yes
Male: yes

550

Phase 2;Phase 3

342

NCT03378921
(ClinicalTrials.gov)

February 27, 2018

11/12/2017

Fecal Microbiota Transplantation in the Treatment of Pouchitis

Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis

Pouchitis;Ulcerative Colitis

Biological: Fecal microbiota transplantation;Biological: Placebo

Helsinki University Central Hospital

NULL

Completed

18 Years

75 Years

All

Phase 2

Finland

343

EUCTR2017-000573-37-CZ
(EUCTR)

27/02/2018

01/11/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

344

EUCTR2017-000599-27-CZ
(EUCTR)

26/02/2018

01/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

345

EUCTR2017-000937-30-AT
(EUCTR)

22/02/2018

03/01/2018

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Poland;Belgium;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

346

NCT03849599
(ClinicalTrials.gov)

February 21, 2018

17/2/2019

A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: PRV-300;Biological: Placebo

Provention Bio, Inc.

NULL

Completed

18 Years

75 Years

All

Phase 1

Georgia;Moldova, Republic of;Ukraine

347

EUCTR2017-000572-28-FR
(EUCTR)

16/02/2018

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Korea, Republic of;Bosnia and Herzegovina

348

EUCTR2017-000572-28-ES
(EUCTR)

16/02/2018

19/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302) - FIGARO UC 302

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

349

EUCTR2017-000573-37-ES
(EUCTR)

16/02/2018

19/12/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

350

NCT03259334
(ClinicalTrials.gov)

February 9, 2018

21/8/2017

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative Colitis

Drug: Ontamalimab;Other: Placebo

Shire

NULL

Completed

16 Years

80 Years

All

380

Phase 3

United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

351

NCT03235752
(ClinicalTrials.gov)

February 6, 2018

28/7/2017

Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis

Active Ulcerative Colitis

Drug: TJ301 300mg;Drug: TJ301 600mg;Drug: Placebo

I-Mab Biopharma HongKong Limited

NULL

Recruiting

18 Years

70 Years

All

Phase 2

Australia;China;Korea, Republic of;Taiwan

352

EUCTR2017-000599-27-LT
(EUCTR)

30/01/2018

31/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

353

EUCTR2017-000573-37-LT
(EUCTR)

30/01/2018

31/10/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

354

EUCTR2017-000402-38-PT
(EUCTR)

29/01/2018

13/11/2017

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: no
Male: yes

250

Phase 2

Portugal;United States;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

355

EUCTR2017-000573-37-BG
(EUCTR)

24/01/2018

22/11/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

356

EUCTR2017-000402-38-DE
(EUCTR)

23/01/2018

27/10/2017

A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

United States;Portugal;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

357

EUCTR2017-000573-37-HU
(EUCTR)

22/01/2018

23/01/2018

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

358

EUCTR2017-000572-28-HU
(EUCTR)

22/01/2018

27/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

359

EUCTR2017-000402-38-AT
(EUCTR)

19/01/2018

30/10/2017

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;New Zealand;Sweden

360

EUCTR2017-000572-28-BG
(EUCTR)

19/01/2018

24/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Ireland;Turkey;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

361

EUCTR2017-000402-38-GB
(EUCTR)

19/01/2018

23/10/2017

A clinical trial to evaluate the testicular safety of Filgotinib in adult males with Moderately to Severely Active Inflammatory Bowel Disease

A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Inflammatory Bowel Disease

To evaluate the testicular safety of filgotinib in adult males with moderately to severely Active Inflammatory Bowel Disease
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10013099;Term: Disease Crohns;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-6034
INN or Proposed INN: FILGOTINIB

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: no
Male: yes

250

Phase 2

United States;Portugal;Spain;Ukraine;Austria;Russian Federation;United Kingdom;India;Canada;Belgium;Poland;Romania;Australia;Germany;Netherlands;New Zealand;Sweden

362

EUCTR2017-000573-37-AT
(EUCTR)

22/12/2017

30/10/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

363

EUCTR2017-000599-27-AT
(EUCTR)

22/12/2017

30/10/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

364

NCT03269695
(ClinicalTrials.gov)

December 20, 2017

30/8/2017

Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission.

Ulcerative Colitis

Drug: PF-06687234;Drug: Placebo

Pfizer

NULL

Active, not recruiting

18 Years

75 Years

All

Phase 2

United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Turkey;Spain

365

EUCTR2017-000937-30-PL
(EUCTR)

13/12/2017

25/09/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Belgium;Poland;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

366

EUCTR2017-000573-37-SK
(EUCTR)

13/12/2017

21/11/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

772

Phase 3

367

EUCTR2017-000572-28-SK
(EUCTR)

13/12/2017

21/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

368

EUCTR2017-000572-28-GR
(EUCTR)

11/12/2017

28/11/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

United States;Portugal;Slovakia;Greece;Spain;Ukraine;Ireland;Colombia;Switzerland;France;Hungary;Mexico;Canada;Argentina;Belgium;Bulgaria;Japan;Bosnia and Herzegovina;Korea, Republic of

369

EUCTR2017-000573-37-GR
(EUCTR)

11/12/2017

01/12/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand

370

NCT03259308
(ClinicalTrials.gov)

December 5, 2017

21/8/2017

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Ulcerative Colitis

Drug: Ontamalimab;Drug: Placebo

Shire

NULL

Terminated

16 Years

80 Years

All

279

Phase 3

United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;Greece;Hungary;Ireland;Japan;Korea, Republic of;Lebanon;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Turkey;Ukraine;France

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

371

EUCTR2017-000937-30-ES
(EUCTR)

27/11/2017

10/10/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Poland;Belgium;Spain;Austria;Germany

372

EUCTR2016-000420-26-BG
(EUCTR)

17/11/2017

19/04/2017

A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body.

A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Spain;Poland;Romania;South Africa;Georgia;Bulgaria;United Kingdom;Moldova, Republic of;Italy

373

NCT03266484
(ClinicalTrials.gov)

November 13, 2017

25/8/2017

Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial

Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis

Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo

Massachusetts General Hospital

Winclove Bio Industries BV

Recruiting

18 Years

75 Years

All

100

N/A

United States

374

EUCTR2016-003708-29-NL
(EUCTR)

09/11/2017

19/07/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: PF-06651600 10 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600 -15
Product Code: PF-06651600 50 mg
INN or Proposed INN: PF-06651600
Other descriptive name: PF-06651600 -15
Product Code: PF-06700841 5 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15
Product Code: PF-06700841 25 mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Ireland;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of

375

EUCTR2017-000937-30-FR
(EUCTR)

07/11/2017

19/09/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Poland;Belgium;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

376

EUCTR2016-001392-78-NL
(EUCTR)

06/11/2017

16/08/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

Mexico;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

377

EUCTR2013-004278-88-PL
(EUCTR)

24/10/2017

09/09/2017

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.

PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED,MULTICENTER STUDY OF THE EFFICACY AND SAFETY OFETROLIZUMAB DURING INDUCTION AND MAINTENANCE INPATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVECOLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNFINHIBITORS - HICKORY

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

378

EUCTR2017-000937-30-DE
(EUCTR)

10/10/2017

25/09/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Moderate to severe Ulcerative Colitis.
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

ABIVAX

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Hungary;Spain;Poland;Belgium;Austria;Germany

379

NCT03093259
(ClinicalTrials.gov)

October 1, 2017

17/3/2017

ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids

Ulcerative Colitis

Drug: ABX464;Drug: Placebo oral capsule

Abivax S.A.

NULL

Completed

18 Years

70 Years

All

Phase 2

Belgium

380

EUCTR2017-000937-30-BE
(EUCTR)

29/09/2017

03/08/2017

Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis.

Product Code: ABX464
INN or Proposed INN: ABX464
Other descriptive name: ABX464

ABIVAX

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Spain;Poland;Belgium;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

381

EUCTR2017-001389-10-GB
(EUCTR)

28/09/2017

17/08/2017

Randomised Double Blind Clinical Trial in Acute Severe Colitis: The IASO trial

A phase II randomised placebo controlled double blinded trial of Interleukin 1 blockade in Acute Severe Colitis - IASO

Acute Severe Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

214

Phase 2

United Kingdom

382

EUCTR2016-000641-31-HR
(EUCTR)

21/08/2017

06/11/2017

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

383

EUCTR2016-003708-29-AT
(EUCTR)

07/08/2017

24/04/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of

384

EUCTR2016-003708-29-DE
(EUCTR)

07/08/2017

24/04/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

United States;Serbia;Slovakia;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Israel;Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of

385

NCT03221036
(ClinicalTrials.gov)

August 3, 2017

14/7/2017

Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

Drug: Vedolizumab IV;Drug: Placebo

Takeda

NULL

Recruiting

18 Years

80 Years

All

302

Phase 3

China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

386

EUCTR2016-003708-29-HU
(EUCTR)

30/06/2017

11/05/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Hungary;Czech Republic;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Netherlands;Germany;Korea, Republic of

387

EUCTR2016-003708-29-DK
(EUCTR)

27/06/2017

21/04/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

388

EUCTR2016-001392-78-HR
(EUCTR)

26/06/2017

12/09/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden;Georgia;United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia

389

EUCTR2016-003452-75-NL
(EUCTR)

23/06/2017

04/01/2017

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS

Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina

390

NCT03178669
(ClinicalTrials.gov)

June 21, 2017

5/6/2017

The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients

Ulcerative Colitis

Drug: cobitolimod;Drug: Placebo

InDex Pharmaceuticals

NULL

Active, not recruiting

18 Years

N/A

All

213

Phase 2

Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

391

NCT03122613
(ClinicalTrials.gov)

June 19, 2017

7/4/2017

Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis

A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis

Ulcerative Colitis in Remission

Dietary Supplement: Curcumin;Drug: Placebo

Chinese University of Hong Kong

NULL

Recruiting

18 Years

N/A

All

172

N/A

Hong Kong

392

NCT03123120
(ClinicalTrials.gov)

June 7, 2017

13/4/2017

A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy

Colitis, Ulcerative

Drug: Spesolimab;Drug: Placebo

Boehringer Ingelheim

NULL

Completed

18 Years

75 Years

All

Phase 2

Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland

393

EUCTR2016-003708-29-PL
(EUCTR)

07/06/2017

26/04/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

394

EUCTR2016-003708-29-LT
(EUCTR)

06/06/2017

18/04/2017

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

395

EUCTR2016-001392-78-SE
(EUCTR)

24/05/2017

12/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

United States;Serbia;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

396

EUCTR2016-000641-31-FR
(EUCTR)

22/05/2017

02/06/2017

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: ABT-494
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden;Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China

397

EUCTR2016-003708-29-ES
(EUCTR)

22/05/2017

31/05/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Serbia;United States;Philippines;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Korea, Republic of

398

NCT02954159
(ClinicalTrials.gov)

May 18, 2017

14/10/2016

Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC

Induction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Tacrolimus;Drug: Vedolizumab;Other: Placebo

Medical College of Wisconsin

Takeda

Terminated

18 Years

65 Years

All

Phase 3

United States

399

EUCTR2015-001942-28-FR
(EUCTR)

16/05/2017

02/12/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

400

EUCTR2016-003452-75-HR
(EUCTR)

11/05/2017

07/06/2017

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Moderate to Severe Active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PTG-100
Product Code: PTG-100
INN or Proposed INN: -
Other descriptive name: PN-10884A
Product Name: PTG-100
Product Code: PTG-100
INN or Proposed INN: -
Other descriptive name: PN-10884A

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

401

NCT03103412
(ClinicalTrials.gov)

May 4, 2017

24/3/2017

TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)

Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects

Drug: TD-3504;Drug: 15N2-tofacitinib;Drug: Placebo

Theravance Biopharma

NULL

Completed

18 Years

55 Years

All

Phase 1

United States

402

NCT03415711
(ClinicalTrials.gov)

April 28, 2017

5/1/2018

PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis

A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC

Ulcerative Colitis

Dietary Supplement: VSL#3®;Drug: Mesalamine;Drug: Placebo

VSL Pharmaceuticals

Actial Farmaceutica S.r.l.

Terminated

18 Years

85 Years

All

N/A

Italy

403

EUCTR2016-001833-29-NL
(EUCTR)

24/04/2017

23/01/2017

A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis

A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Germany;Netherlands;United Kingdom;Sweden

404

EUCTR2016-001392-78-IS
(EUCTR)

24/04/2017

21/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1300

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

405

EUCTR2016-001684-36-ES
(EUCTR)

19/04/2017

10/03/2017

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.1;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

406

EUCTR2016-003708-29-SK
(EUCTR)

18/04/2017

24/02/2017

Moderate to severe Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Italy;Czech Republic;Hungary;Canada;Poland;Romania;Denmark;Bulgaria;Georgia;Germany;Netherlands;Korea, Republic of;United States;Serbia;Slovakia;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Israel

407

EUCTR2016-001392-78-BG
(EUCTR)

04/04/2017

07/02/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

408

EUCTR2016-003452-75-CZ
(EUCTR)

03/04/2017

19/12/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Serbia;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

409

EUCTR2016-001392-78-GR
(EUCTR)

31/03/2017

14/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

410

EUCTR2016-001392-78-BE
(EUCTR)

31/03/2017

09/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

411

EUCTR2016-000641-31-LT
(EUCTR)

31/03/2017

11/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

412

EUCTR2016-001392-78-DE
(EUCTR)

27/03/2017

05/04/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

413

EUCTR2015-001942-28-DE
(EUCTR)

27/03/2017

13/10/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

414

EUCTR2015-002558-11-BG
(EUCTR)

14/03/2017

06/01/2017

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

415

EUCTR2015-002557-35-BG
(EUCTR)

14/03/2017

06/01/2017

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

416

EUCTR2016-001392-78-PT
(EUCTR)

13/03/2017

13/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

United States;Serbia;Belarus;Portugal;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Switzerland;Italy;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Iceland;New Zealand;Japan;Sweden

417

EUCTR2016-000641-31-CZ
(EUCTR)

02/03/2017

29/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil

418

NCT02914535
(ClinicalTrials.gov)

February 23, 2017

22/9/2016

Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis

A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis

Ulcerative Colitis

Drug: Filgotinib;Drug: Placebo

Gilead Sciences

Galapagos NV

Active, not recruiting

18 Years

N/A

All

1173

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic;Iceland

419

EUCTR2016-001684-36-LV
(EUCTR)

20/02/2017

22/12/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy

420

EUCTR2016-003452-75-LV
(EUCTR)

20/02/2017

23/11/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

421

EUCTR2016-001392-78-SK
(EUCTR)

16/02/2017

14/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

422

EUCTR2016-003452-75-HU
(EUCTR)

13/02/2017

01/12/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Hungary;Czech Republic;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

423

EUCTR2016-003452-75-BE
(EUCTR)

13/02/2017

07/12/2016

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Germany;Latvia;Netherlands;Bosnia and Herzegovina

424

EUCTR2016-003452-75-PL
(EUCTR)

09/02/2017

04/01/2017

A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon

Protagonist Therapeutics, Inc

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Netherlands;Germany;Latvia;Bosnia and Herzegovina

425

NCT03071081
(ClinicalTrials.gov)

February 8, 2017

20/2/2017

Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy Volunteers

Ulcerative Colitis

Drug: TOP1288;Drug: Placebo to TOP1288

Topivert Pharma Ltd

NULL

Completed

18 Years

55 Years

Male

Phase 1

United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

426

EUCTR2016-000641-31-FI
(EUCTR)

07/02/2017

26/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

427

NCT02958865
(ClinicalTrials.gov)

February 3, 2017

4/11/2016

Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative Colitis

Drug: PF-06651600 or Placebo;Drug: PF-06700841 or Placebo;Drug: PF-06700841;Drug: PF-06651600

Pfizer

NULL

Active, not recruiting

18 Years

75 Years

All

318

Phase 2

United States;Austria;Bulgaria;Czechia;Denmark;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Turkey;Ukraine;Canada;Netherlands

428

NCT03038711
(ClinicalTrials.gov)

February 1, 2017

26/1/2017

A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers

A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

Ulcerative Colitis

Drug: BMS-986166;Other: Placebo matching BMS-986166

Bristol-Myers Squibb

NULL

Completed

18 Years

55 Years

All

213

Phase 1

United States

429

ChiCTR-IPR-17010306

2017-02-01

2017-01-01

Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis

Ulcerative colitis

Group A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control;

Affiliated Hospital of Inner Mongolia Medical University

NULL

Pending

Both

Group A:30; Group B:30;Group C:30;Normal control group:30;

China

430

NCT03006068
(ClinicalTrials.gov)

January 31, 2017

20/12/2016

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: Upadacitinib (ABT-494);Drug: Placebo

AbbVie

NULL

Enrolling by invitation

16 Years

75 Years

All

950

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Egypt;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

431

EUCTR2016-001392-78-AT
(EUCTR)

31/01/2017

13/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

432

EUCTR2016-000420-26-PL
(EUCTR)

31/01/2017

01/02/2017

SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 20.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Spain;Poland;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom

433

EUCTR2016-001392-78-ES
(EUCTR)

31/01/2017

01/02/2017

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Other descriptive name: Filgotinib

Gilead Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1300

Phase 2;Phase 3

Serbia;Portugal;Belarus;United States;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden

434

EUCTR2016-001392-78-HU
(EUCTR)

30/01/2017

01/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

435

EUCTR2016-000641-31-SE
(EUCTR)

30/01/2017

29/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

436

NCT03000101
(ClinicalTrials.gov)

January 19, 2017

19/12/2016

Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE)

Crohn's Disease;Ulcerative Colitis

Other: 100% pomegranate juice;Other: placebo beverage

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

University of Bologna;Conserve Italia;GAT Foods

Active, not recruiting

18 Years

80 Years

All

N/A

Italy

437

EUCTR2015-000319-41-HR
(EUCTR)

17/01/2017

05/06/2017

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

438

EUCTR2016-001833-29-PL
(EUCTR)

09/01/2017

26/10/2016

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Netherlands;Germany;United Kingdom;Sweden

439

EUCTR2016-000641-31-PT
(EUCTR)

09/01/2017

06/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Portugal;Belarus;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

440

NCT03798210
(ClinicalTrials.gov)

January 1, 2017

7/1/2019

Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis

The Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative Colitis

Ulcerative Colitis Flare

Dietary Supplement: Lactobacillus reuteri;Dietary Supplement: Placebo

Uppsala University

NULL

Recruiting

18 Years

80 Years

All

Phase 2

Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

441

EUCTR2016-000641-31-IE
(EUCTR)

22/12/2016

04/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

442

EUCTR2016-000641-31-GR
(EUCTR)

19/12/2016

12/10/2016

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: ABT-494
INN or Proposed INN: -
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: -
Other descriptive name: ABT-494
Product Name: ABT-494
INN or Proposed INN: -
Other descriptive name: ABT-494

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

443

EUCTR2016-000641-31-ES
(EUCTR)

16/12/2016

14/12/2016

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

444

JPRN-UMIN000024520

2016/12/15

22/10/2016

Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis

ulcerative colitis

placebo
metronidazole
metronidazole,amoxicillin
metronidazole,amoxicillin,tetracycline

Hokkaido University Hospital

NULL

Complete: follow-up complete

16years-old

80years-old

Male and Female

212

Not selected

Japan

445

EUCTR2016-001684-36-SK
(EUCTR)

12/12/2016

26/07/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

446

EUCTR2016-000641-31-EE
(EUCTR)

08/12/2016

03/11/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden;Argentina;Belgium;Poland;Brazil;Portugal;Serbia;Belarus;United States;Saudi Arabia;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;European Union;Mexico;Canada

447

EUCTR2016-001392-78-GB
(EUCTR)

08/12/2016

06/12/2016

A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis

Gilead Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1300

Phase 2;Phase 3

448

EUCTR2016-000641-31-GB
(EUCTR)

07/12/2016

11/01/2017

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

449

NCT02895100
(ClinicalTrials.gov)

December 2016

4/9/2016

Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis

Ulcerative Colitis

Drug: PTG-100;Drug: Placebo

Protagonist Therapeutics, Inc.

NULL

Terminated

18 Years

80 Years

All

100

Phase 2

United States;Australia;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Germany;Hungary;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Ukraine

450

NCT02985593
(ClinicalTrials.gov)

December 2016

28/11/2016

A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis

A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis

Healthy Men and Subjects With Ulcerative Colitis

Drug: KHK4083;Drug: Placebo

Kyowa Kirin Co., Ltd.

NULL

Completed

20 Years

N/A

All

155

Phase 1

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

451

EUCTR2016-000641-31-HU
(EUCTR)

29/11/2016

28/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

452

NCT03018054
(ClinicalTrials.gov)

November 28, 2016

10/1/2017

Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

A Phase 2, Double-Blind, Parallel-Group, Placebo-Controlled Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis

Moderate Active Ulcerative Colitis

Drug: E6007;Drug: Placebo

EA Pharma Co., Ltd.

NULL

Completed

20 Years

74 Years

All

147

Phase 2

Japan

453

NCT02808390
(ClinicalTrials.gov)

November 28, 2016

14/6/2016

Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC

A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: Placebo

PPM Services S.A.

NULL

Terminated

18 Years

N/A

All

Phase 2

United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine

454

EUCTR2016-000641-31-NL
(EUCTR)

23/11/2016

08/08/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

455

EUCTR2016-000641-31-LV
(EUCTR)

22/11/2016

10/10/2016

Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

456

EUCTR2016-001684-36-BG
(EUCTR)

17/11/2016

18/10/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10021184;Term: IBD;System Organ Class: 100000016704
MedDRA version: 20.0;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670
MedDRA version: 20.0;Classification code 10045366;Term: Ulcerative colitis, unspecified;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom

457

NCT02903966
(ClinicalTrials.gov)

November 15, 2016

13/9/2016

GSK2982772 Study in Subjects With Ulcerative Colitis

A Multicentre, Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled Study With Open Label Extension to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Active Ulcerative Colitis

Colitis, Ulcerative

Drug: GSK2982772;Drug: Placebo

GlaxoSmithKline

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Germany;Netherlands;Poland;Russian Federation;Sweden;United Kingdom

458

NCT02914522
(ClinicalTrials.gov)

November 14, 2016

22/9/2016

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Filgotinib;Drug: Placebo to match filgotinib

Gilead Sciences

Galapagos NV

Completed

18 Years

75 Years

All

1351

Phase 3

United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Iceland

459

EUCTR2016-000518-31-CZ
(EUCTR)

07/11/2016

30/08/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

460

NCT02910245
(ClinicalTrials.gov)

November 2016

9/9/2016

Mercaptopurine Therapy in Ulcerative Colitis

Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC)

Colitis, Ulcerative

Drug: Mercaptopurine (Purinethol);Drug: Placebo;Drug: Mesalamine;Drug: Prednisone

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

ZonMw: The Netherlands Organisation for Health Research and Development

Recruiting

18 Years

80 Years

All

136

Phase 3

Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

461

NCT03136419
(ClinicalTrials.gov)

October 31, 2016

5/4/2017

Microbiota and Immune microEnvironment in Pouchitis

Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa

Pouchitis;Ulcerative Colitis;Ileal Pouch

Dietary Supplement: Lactobacillus casei DG;Dietary Supplement: Placebo

University of Padova

NULL

Recruiting

18 Years

100 Years

All

N/A

Italy

462

EUCTR2016-000641-31-PL
(EUCTR)

25/10/2016

30/09/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;United States;Serbia;Saudi Arabia;Estonia;Spain;Ireland;Israel;Russian Federation;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

463

EUCTR2013-004280-31-SK
(EUCTR)

21/10/2016

26/07/2016

A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors

PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Germany;United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Denmark;South Africa

464

EUCTR2016-000518-31-PL
(EUCTR)

21/10/2016

19/08/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

465

EUCTR2016-001684-36-HU
(EUCTR)

19/10/2016

10/08/2016

EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Product Name: GED-0507-34-Levo
Product Code: GED0507
INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid
Other descriptive name: GED-0507-34-LEVO

PPM SERVICES SA

NULL

Not Recruiting

Female: yes
Male: yes

207

Phase 2

United States;Slovakia;Spain;Ukraine;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

466

EUCTR2016-000641-31-AT
(EUCTR)

17/10/2016

11/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

467

EUCTR2016-000420-26-CZ
(EUCTR)

06/10/2016

27/07/2016

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom

468

EUCTR2016-000420-26-ES
(EUCTR)

05/10/2016

05/08/2016

SEVERE ACTIVE ULCERATIVE COLITIS
MedDRA version: 19.0;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Bimekizumab
Product Code: UCB4940
INN or Proposed INN: Bimekizumab
Other descriptive name: UCB4940

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Spain;Romania;France;Czech Republic;Bulgaria;South Africa;Georgia;United Kingdom;Moldova, Republic of;Italy

469

EUCTR2016-000518-31-HU
(EUCTR)

05/10/2016

27/07/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Czech Republic;Hungary;Canada;Poland;Netherlands

470

NCT02818686
(ClinicalTrials.gov)

October 3, 2016

23/6/2016

TD-1473 for Active Ulcerative Colitis (UC)

A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis

Ulcerative Colitis, Active Moderate;Ulcerative Colitis, Active Severe

Drug: TD-1473;Drug: Placebo

Theravance Biopharma

NULL

Completed

18 Years

75 Years

All

Phase 1

United States;Georgia;Moldova, Republic of;Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

471

EUCTR2013-004280-31-PL
(EUCTR)

29/09/2016

12/09/2016

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

472

JPRN-JapicCTI-163356

29/9/2016

23/08/2016

I6T-MC-AMAC

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Intervention name : LY3074828
INN of the intervention : mirikizumab
Dosage And administration of the intervention : Induction:High, Mid or Low dose LY3074828. Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:LY3074828 dose schedule1 or 2.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction:Placebo Participants who do not have a clinical response may choose to participate in the unblinded study extension period -Maintenance:Placebo

Eli Lilly Japan K.K.

NULL

complete

BOTH

Phase 2

Japan, North America, Europe, Oceania

473

NCT02819635
(ClinicalTrials.gov)

September 26, 2016

28/6/2016

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: Placebo;Drug: Updacitinib (ABT-494)

AbbVie

NULL

Recruiting

16 Years

75 Years

All

844

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Egypt;Romania

474

EUCTR2016-000641-31-SK
(EUCTR)

20/09/2016

26/07/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

475

EUCTR2016-001833-29-GB
(EUCTR)

16/09/2016

08/08/2016

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Poland;Netherlands;Germany;United Kingdom;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

476

NCT02864264
(ClinicalTrials.gov)

September 14, 2016

9/8/2016

Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis

Healthy Volunteers;Ulcerative Colitis

Drug: BMS-986184;Drug: Placebo matching BMS-986184

Bristol-Myers Squibb

NULL

Terminated

18 Years

75 Years

All

Phase 1

Australia;Georgia;Moldova, Republic of;Romania

477

EUCTR2016-001833-29-SE
(EUCTR)

07/09/2016

19/07/2016

A multicentre, randomised, double-blind (sponsor-unblinded),placebo-controlled study with open label extension to investigatethe safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.

Active ulcerative colitis
MedDRA version: 20.0;Level: HLGT;Classification code 10017969;Term: Gastrointestinal inflammatory conditions;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: GSK2982772
Product Code: GSK2982772
INN or Proposed INN: Not Available
Other descriptive name: GSK2982772A, where A denotes the free base

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Poland;Russian Federation;Netherlands;Germany;United Kingdom;Sweden

478

EUCTR2015-002558-11-LV
(EUCTR)

01/09/2016

01/07/2016

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia

479

EUCTR2015-002557-35-LV
(EUCTR)

01/09/2016

01/07/2016

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia

480

NCT02825914
(ClinicalTrials.gov)

September 1, 2016

30/6/2016

CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM)

Colitis, Ulcerative;Inflammatory Bowel Diseases

Dietary Supplement: Casein glycomacropeptide (CGMP);Dietary Supplement: Placebo

University of Aarhus

NULL

Completed

18 Years

N/A

All

N/A

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

481

NCT02888379
(ClinicalTrials.gov)

September 2016

30/8/2016

Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients With Moderate to Severe Disease Activity

Ulcerative Colitis

Drug: TOP1288;Drug: Placebo (for TOP1288)

Topivert Pharma Ltd

NULL

Completed

18 Years

75 Years

All

Phase 2

Bulgaria;Czechia;Hungary;Latvia;Lithuania;Poland;Ukraine;United Kingdom;Czech Republic

482

EUCTR2016-000390-20-BG
(EUCTR)

29/08/2016

18/07/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

483

EUCTR2015-003123-57-PL
(EUCTR)

26/08/2016

16/05/2016

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

484

EUCTR2015-001942-28-AT
(EUCTR)

26/08/2016

28/06/2016

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Latvia

485

EUCTR2016-000518-31-NL
(EUCTR)

16/08/2016

27/06/2016

A STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TREATMENT WITH LYC-30937-EC IN PATIENTS WITH ULCERATIVE COLITIS

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF INDUCTION THERAPY WITH LYC-30937-EC IN SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Ulcerative Colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: LYC-30937 -EC
INN or Proposed INN: LYC-30937
Other descriptive name: LYC-30937

Lycera Corp.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Serbia;United States;Hungary;Czech Republic;Canada;Poland;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

486

EUCTR2016-000390-20-CZ
(EUCTR)

18/07/2016

Symptomatic Ulcerative Colitis Patients with Moderate to Severe DiseaseActivity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

487

EUCTR2016-000390-20-LT
(EUCTR)

15/07/2016

05/07/2016

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

488

EUCTR2016-000390-20-HU
(EUCTR)

05/07/2016

14/06/2016

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

489

NCT02849951
(ClinicalTrials.gov)

July 2016

26/7/2016

A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC)

A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine

Ulcerative Colitis

Drug: LT-02;Drug: LT-02 Placebo

Prometheus Laboratories

Nestlé Health Science Spain;INC Research

Terminated

18 Years

70 Years

All

Phase 3

United States

490

NCT02762500
(ClinicalTrials.gov)

July 2016

3/5/2016

An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis

Colitis, Ulcerative

Drug: LYC-30937-EC;Drug: Placebo

Lycera Corp.

NULL

Completed

18 Years

75 Years

All

124

Phase 2

United States;Canada;Czechia;Hungary;Netherlands;Poland;Serbia;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

491

EUCTR2015-000480-14-BE
(EUCTR)

30/06/2016

14/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
INN or Proposed INN: Vedolizumab
Other descriptive name: VEDOLIZUMAB
Product Name: Vedolizumab SC
Product Code: MLN0002 SC
INN or Proposed INN: Vedolizumab SC

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

492

EUCTR2014-005217-24-ES
(EUCTR)

29/06/2016

10/11/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance StudyEvaluating the Safety and Efficacy of GS-5745 in Subjects with Moderately to Severely Active Ulcerative Colitis - NA

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden

493

EUCTR2016-000390-20-PL
(EUCTR)

28/06/2016

16/06/2016

English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

494

EUCTR2016-000390-20-LV
(EUCTR)

17/06/2016

14/06/2016

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease Activity

Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

495

NCT02365480
(ClinicalTrials.gov)

June 16, 2016

17/2/2015

Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission

Phase I Trial of Berberine in Subjects With Ulcerative Colitis

Ulcerative Colitis

Drug: Berberine Chloride;Other: Laboratory Biomarker Analysis;Other: Placebo Administration

National Cancer Institute (NCI)

NULL

Active, not recruiting

18 Years

70 Years

All

Phase 1

United States;China

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

496

EUCTR2015-000480-14-DE
(EUCTR)

14/06/2016

09/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

497

EUCTR2015-000480-14-HR
(EUCTR)

10/06/2016

06/07/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

498

EUCTR2016-000390-20-GB
(EUCTR)

10/06/2016

06/06/2016

Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

TOPIVERT Pharma Limited

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom

499

EUCTR2015-003123-57-DK
(EUCTR)

03/06/2016

22/03/2016

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Australia;Georgia;Netherlands;Moldova, Republic of;Japan

500

EUCTR2015-003123-57-NL
(EUCTR)

02/06/2016

12/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: LY3074828
INN or Proposed INN: Not assigned
Other descriptive name: LY3074828

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

501

NCT02647866
(ClinicalTrials.gov)

June 2016

8/12/2015

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UC

Ulcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal Pain

Drug: KHK4083;Drug: Placebo

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Completed

18 Years

N/A

All

Phase 2

United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico

502

EUCTR2015-000480-14-DK
(EUCTR)

31/05/2016

17/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

503

EUCTR2015-000480-14-ES
(EUCTR)

29/05/2016

18/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

504

EUCTR2014-005217-24-DE
(EUCTR)

24/05/2016

23/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

505

EUCTR2014-005217-24-IS
(EUCTR)

10/05/2016

28/04/2016

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

506

EUCTR2015-000480-14-HU
(EUCTR)

09/05/2016

22/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Lithuania;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

507

EUCTR2015-000480-14-LT
(EUCTR)

04/05/2016

18/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

508

EUCTR2015-001942-28-BE
(EUCTR)

03/05/2016

17/03/2016

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Latvia

509

NCT02606032
(ClinicalTrials.gov)

May 2016

13/11/2015

Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis

Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis

Ulcerative Colitis

Drug: Metronidazole;Drug: Doxycycline;Drug: Terbinafine;Drug: Placebo

Hamilton Health Sciences Corporation

Hamilton Academic Health Sciences Organization

Recruiting

18 Years

N/A

All

Phase 2

Canada

510

EUCTR2015-001942-28-PL
(EUCTR)

29/04/2016

19/01/2016

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

156

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Latvia;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

511

EUCTR2015-001555-69-PL
(EUCTR)

28/04/2016

22/12/2015

A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis

Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation

512

EUCTR2015-000480-14-CZ
(EUCTR)

13/04/2016

21/01/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

513

NCT02749630
(ClinicalTrials.gov)

April 11, 2016

12/4/2016

A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)

An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease

Ulcerative Colitis;Crohn's Disease

Drug: Placebo;Drug: UTTR1147A

Genentech, Inc.

NULL

Completed

18 Years

80 Years

All

Phase 1

Germany;United Kingdom;Canada

514

EUCTR2015-000480-14-SE
(EUCTR)

04/04/2016

16/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

515

EUCTR2014-005217-24-HR
(EUCTR)

29/03/2016

28/04/2016

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

516

EUCTR2015-003123-57-GB
(EUCTR)

29/03/2016

04/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

517

EUCTR2015-000480-14-NL
(EUCTR)

21/03/2016

29/12/2015

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

518

EUCTR2015-000480-14-BG
(EUCTR)

17/03/2016

16/02/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

519

EUCTR2015-000480-14-GB
(EUCTR)

14/03/2016

07/03/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Serbia;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Germany;Japan;Sweden

520

EUCTR2013-001205-84-BE
(EUCTR)

11/03/2016

17/02/2015

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE
Trade Name: Salofalk Granu-Stix 500 mg
INN or Proposed INN: MESALAZINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

521

EUCTR2015-001555-69-CZ
(EUCTR)

07/03/2016

14/12/2015

A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.

Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation

522

EUCTR2013-001205-84-HU
(EUCTR)

07/03/2016

04/01/2016

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

523

EUCTR2014-005217-24-SE
(EUCTR)

02/03/2016

03/11/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

524

EUCTR2015-003123-57-BE
(EUCTR)

09/02/2016

01/10/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

525

EUCTR2015-002558-11-HU
(EUCTR)

09/02/2016

16/11/2015

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

526

EUCTR2015-002557-35-HU
(EUCTR)

09/02/2016

16/11/2015

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland

527

EUCTR2014-005606-38-PL
(EUCTR)

05/02/2016

17/11/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis - UNIFI

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

United States;Serbia;Slovakia;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

528

NCT02579733
(ClinicalTrials.gov)

February 1, 2016

16/10/2015

Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: Azathioprine;Drug: Placebo

Kyungpook National University Hospital

Celltrion

Terminated

18 Years

80 Years

All

Phase 4

Korea, Republic of

529

NCT02522780
(ClinicalTrials.gov)

February 1, 2016

12/8/2015

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Ulcerative Colitis

Drug: Mesalamine;Drug: Placebo

Ferring Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

276

Phase 3

United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium

530

EUCTR2015-000319-41-NL
(EUCTR)

26/01/2016

01/07/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

531

EUCTR2015-000480-14-SK
(EUCTR)

22/01/2016

05/01/2016

Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Takeda Development Centre Europe, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

532

EUCTR2014-002981-64-BG
(EUCTR)

20/01/2016

25/09/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

533

EUCTR2015-001555-69-HU
(EUCTR)

15/01/2016

17/11/2015

A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.

Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available

Kyowa Kirin Pharmaceutical Development, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation

534

EUCTR2014-005217-24-BE
(EUCTR)

14/01/2016

26/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden

535

EUCTR2015-003123-57-CZ
(EUCTR)

14/01/2016

05/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

536

NCT02618187
(ClinicalTrials.gov)

January 13, 2016

20/11/2015

A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: SER-287;Drug: Placebo;Drug: Placebo Pre-Treat;Drug: Vancomycin Pre-Treat

Seres Therapeutics, Inc.

NULL

Completed

18 Years

75 Years

All

Phase 1

United States

537

EUCTR2015-001942-28-GB
(EUCTR)

12/01/2016

21/09/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

538

EUCTR2015-003123-57-HU
(EUCTR)

05/01/2016

06/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

539

EUCTR2014-005217-24-BG
(EUCTR)

05/01/2016

19/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

540

NCT02493712
(ClinicalTrials.gov)

January 2016

7/7/2015

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis

Colitis, Ulcerative

Drug: High dose;Drug: Low dose;Drug: Placebo

Holy Stone Healthcare Co., Ltd

inVentiv Health Clinical

Completed

18 Years

75 Years

All

Phase 2

Italy;Taiwan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

541

EUCTR2015-001942-28-LT
(EUCTR)

31/12/2015

20/11/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Czech Republic;Canada;Poland;Belgium;Romania;United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Australia;Bulgaria;Latvia;Germany;New Zealand;Korea, Republic of

542

EUCTR2015-003123-57-LT
(EUCTR)

31/12/2015

17/11/2015

An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan

543

EUCTR2014-005217-24-CZ
(EUCTR)

22/12/2015

06/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

544

NCT02611830
(ClinicalTrials.gov)

December 18, 2015

19/11/2015

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Colitis, Ulcerative

Drug: Vedolizumab 300 mg IV;Drug: Placebo IV;Drug: Vedolizumab 108 mg SC;Drug: Placebo SC

Takeda

NULL

Completed

18 Years

80 Years

All

383

Phase 3

United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic

545

JPRN-JapicCTI-163222

18/12/2015

08/04/2016

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Colitis, Ulcerative

Intervention name : Vedolizumab Intravenous (IV), Vedolizumab Subcutaneous (SC), Placebo IV
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 108 mg SC : Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab SC in maintenance phase. Vedolizumab subcutaneous (SC), 108 mg, injection, once every 2 weeks (Q2W) and placebo-matching IV infusions, once every 8 weeks (Q8W), starting at Week 6 up to approximately Week 50.
Intervention name : Vedolizumab IV, Placebo SC
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Induction IV + Vedolizumab 300 mg IV: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive vedolizumab IV in maintenance phase. Vedolizumab 300 mg, IV infusion, Q8W and placebo-matching SC injection, Q2W starting at Week 6 up to approximately Week 50.
Intervention name : Vedolizumab IV, Placebo IV, Placebo SC
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Induction IV + Placebo: Participants received vedolizumab 300 mg IV infusion in open-label induction phase and achieved clinical response at Week 6 were randomized to receive placebo in maintenance phase. Placebo-matching SC injections, Q2W and placebo-matching IV infusions, Q8W starting at Week 6 up to approximately Week 50.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Takeda Pharmaceutical Company Limited

NULL

complete

BOTH

383

Phase 3

Japan, Japan, Refer to Other section

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

546

EUCTR2014-005217-24-NL
(EUCTR)

17/12/2015

26/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

547

EUCTR2015-001942-28-CZ
(EUCTR)

10/12/2015

15/09/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

548

NCT02589665
(ClinicalTrials.gov)

December 9, 2015

27/10/2015

A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis

A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: Mirikizumab;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

75 Years

All

249

Phase 2

United States;Australia;Belgium;Canada;Czechia;Denmark;France;Georgia;Hungary;Japan;Lithuania;Moldova, Republic of;Netherlands;Poland;Romania;United Kingdom;Czech Republic;Puerto Rico;Russian Federation;Ukraine

549

EUCTR2015-002558-11-BE
(EUCTR)

07/12/2015

04/11/2015

A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis

Ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 2g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of

550

EUCTR2015-002557-35-BE
(EUCTR)

07/12/2015

04/11/2015

A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis

Active, mild to moderate ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Pentasa Compact 4g, granulate with prolonged release
INN or Proposed INN: MESALAZINE
Other descriptive name: Mesalamine , 5-aminosalicylic acid [5-ASA]

Ferring International PharmaScience Center U.S., Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

551

EUCTR2015-001942-28-ES
(EUCTR)

04/12/2015

05/10/2015

A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease)

Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: APD334
INN or Proposed INN: Not yet available
Product Code: APD334
INN or Proposed INN: Not yet available

Arena Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand

552

EUCTR2015-001022-42-IT
(EUCTR)

01/12/2015

29/03/2019

A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

Active, Mild to Moderate Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Holy Stone Healthcare Co., Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Italy

553

NCT02390726
(ClinicalTrials.gov)

December 2015

19/2/2015

Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

Ulcerative Colitis, Active Moderate

Biological: Fecal Microbiota Transplant;Biological: Placebo

University of Vermont

NULL

Unknown status

18 Years

75 Years

All

Early Phase 1

United States

554

EUCTR2014-005217-24-GB
(EUCTR)

27/11/2015

22/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

United States;Belarus;Philippines;Hong Kong;Taiwan;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Croatia;Romania;Bulgaria;Iceland;Germany;New Zealand;Sweden

555

EUCTR2014-005217-24-HU
(EUCTR)

19/11/2015

22/09/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

556

EUCTR2014-005217-24-IE
(EUCTR)

12/11/2015

11/12/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

557

EUCTR2014-005217-24-SK
(EUCTR)

12/11/2015

07/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

558

EUCTR2014-005217-24-LV
(EUCTR)

06/11/2015

03/11/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden

559

EUCTR2014-005217-24-AT
(EUCTR)

06/11/2015

22/10/2015

An investigational study to assess the safety and effectiveness of a new investgational drug in people with moderately to severely active Ulcerative Colitis

Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745

Gilead Sciences, Inc

NULL

Not Recruiting

Female: yes
Male: yes

1600

Phase 2;Phase 3

Ukraine;Ireland;Israel;Colombia;Switzerland;Vietnam;India;Malaysia;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Brazil;Iran, Islamic Republic of;Romania;Croatia;Bulgaria;Iceland;Germany;New Zealand;Sweden;Belarus;United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain

560

EUCTR2014-005606-38-DK
(EUCTR)

02/11/2015

30/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Australia;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

561

NCT02330653
(ClinicalTrials.gov)

November 2015

29/12/2014

Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis

A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis and Pediatric Active Crohn's Colitis

Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease

Biological: Fecal Microbiota Transplant (FMT);Biological: Placebo

Stacy A. Kahn

NULL

Completed

5 Years

30 Years

All

Phase 1;Phase 2

United States

562

NCT02487238
(ClinicalTrials.gov)

November 2015

25/6/2015

Pediatric FEcal Microbiota Transplant for Ulcerative Colitis

A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified

Inflammatory Bowel Disease;Ulcerative Colitis

Biological: Fecal Microbiota Enema;Biological: Normal Saline Enema

McMaster Children's Hospital

London Health Sciences Centre;St. Justine's Hospital

Completed

3 Years

17 Years

All

Phase 1

Canada

563

NCT02536404
(ClinicalTrials.gov)

November 2015

24/8/2015

Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Etrasimod;Drug: Placebo

Arena Pharmaceuticals

NULL

Completed

18 Years

80 Years

All

118

Phase 2

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Latvia;Lithuania;New Zealand;Poland;Romania;Spain;Ukraine;United Kingdom

564

EUCTR2015-000319-41-SK
(EUCTR)

22/10/2015

04/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis

ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

1050

Phase 3

Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

565

EUCTR2014-005606-38-SK
(EUCTR)

22/10/2015

07/07/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

566

EUCTR2014-005606-38-BG
(EUCTR)

21/10/2015

03/09/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;Bulgaria;South Africa;Netherlands;Germany;New Zealand;Korea, Republic of

567

EUCTR2013-001205-84-AT
(EUCTR)

13/10/2015

02/09/2015

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

568

EUCTR2014-002981-64-NL
(EUCTR)

12/10/2015

19/05/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 2

United States;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand

569

EUCTR2014-005606-38-DE
(EUCTR)

07/10/2015

04/05/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

570

EUCTR2015-000319-41-BE
(EUCTR)

06/10/2015

24/07/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

900

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

571

NCT02522767
(ClinicalTrials.gov)

October 2015

12/8/2015

Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Ulcerative Colitis

Drug: Mesalamine;Drug: Placebo

Ferring Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

228

Phase 3

United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium

572

EUCTR2014-002981-64-DE
(EUCTR)

29/09/2015

08/06/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

573

EUCTR2014-005606-38-BE
(EUCTR)

24/09/2015

08/07/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

574

EUCTR2015-000319-41-DE
(EUCTR)

18/09/2015

02/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

1050

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

575

EUCTR2014-005606-38-NL
(EUCTR)

16/09/2015

03/07/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

576

EUCTR2015-000319-41-CZ
(EUCTR)

14/09/2015

16/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

577

EUCTR2014-002981-64-HU
(EUCTR)

14/09/2015

27/05/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Netherlands;Germany;New Zealand

578

NCT02520284
(ClinicalTrials.gov)

September 2015

7/8/2015

Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis

A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: Andecaliximab;Biological: Placebo

Gilead Sciences

NULL

Terminated

18 Years

75 Years

All

165

Phase 2;Phase 3

United States;Australia;Belgium;Bulgaria;Canada;Czechia;France;Hungary;Ireland;Italy;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Switzerland;Taiwan;Ukraine;United Kingdom;Austria;Croatia;Czech Republic;Germany;Hong Kong;Iceland;Israel;Serbia;Spain;Sweden

579

NCT02537210
(ClinicalTrials.gov)

September 2015

28/8/2015

Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis

Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial

Colitis, Ulcerative;Aminosalicylic Acid

Drug: Mesalazine;Drug: Placebo oral capsule

Chinese University of Hong Kong

Queen Elizabeth Hospital, Hong Kong;Alice Ho Miu Ling Nethersole Hospital;Tseung Kwan O Hospital, Hong Kong

Recruiting

18 Years

N/A

All

194

N/A

Hong Kong;China

580

NCT02084550
(ClinicalTrials.gov)

September 2015

5/3/2014

Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial

Ulcerative Colitis

Dietary Supplement: Vaminolac;Other: Saline

Aarhus University Hospital

NULL

Active, not recruiting

18 Years

50 Years

All

N/A

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

581

EUCTR2014-005606-38-CZ
(EUCTR)

27/08/2015

26/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

582

EUCTR2014-002981-64-IT
(EUCTR)

20/08/2015

05/11/2020

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A Phase 2, randomized, placebo-controlled, multicenter study to investigate the efficacy and safety of apremilast (CC-10004) for treatment of subjects with active ulcerative colitis - na

Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: [CC-10004]
INN or Proposed INN: Apremilast
Other descriptive name: APREMILAST
Product Name: Apremilast
Product Code: CC -10004
INN or Proposed INN: APREMILAST
Other descriptive name: APREMILAST

CELGENE CORPORATION

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United States;Czechia;Slovakia;Spain;Ukraine;Turkey;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

583

EUCTR2014-002981-64-CZ
(EUCTR)

13/08/2015

05/05/2015

Clinical trial that will compare the efficacy and safety of apremilast versus placebo, in patients with active ulcerative colitis, a chronic inflammatory of the colon of unknown origin

A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS

Subjects with active ulcerative colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

165

Phase 2

United States;Slovakia;Ukraine;Russian Federation;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand

584

EUCTR2014-005606-38-HU
(EUCTR)

12/08/2015

16/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

951

Phase 3

Serbia;United States;Slovakia;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Denmark;South Africa;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

585

EUCTR2015-000319-41-GB
(EUCTR)

10/08/2015

13/07/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Australia;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

586

EUCTR2015-000319-41-HU
(EUCTR)

10/08/2015

05/06/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sárl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand

587

EUCTR2014-005606-38-AT
(EUCTR)

20/07/2015

16/06/2015

A Study to Evaluate the Safety and Efficacy of the Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab
Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: Ustekinumab

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

951

Phase 3

588

NCT02407236
(ClinicalTrials.gov)

July 10, 2015

30/3/2015

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative;Inflammatory Bowel Diseases

Drug: Placebo IV;Drug: Placebo SC;Drug: Ustekinumab IV;Drug: Ustekinumab SC

Janssen Research & Development, LLC

NULL

Active, not recruiting

18 Years

N/A

All

961

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic;South Africa

589

NCT02447302
(ClinicalTrials.gov)

July 2015

13/5/2015

Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Etrasimod;Drug: Placebo

Arena Pharmaceuticals

NULL

Completed

18 Years

80 Years

All

156

Phase 2

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Lithuania;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom

590

NCT01671956
(ClinicalTrials.gov)

July 2015

9/8/2012

Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis

Ulcerative Colitis, Active Moderate;Ulcerative Colitis, Active Severe

Biological: Bertilimumab;Biological: Placebo

Immune Pharmaceuticals

NULL

Unknown status

18 Years

70 Years

All

Phase 2

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

591

NCT02497469
(ClinicalTrials.gov)

June 29, 2015

10/7/2015

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis

Colitis, Ulcerative

Drug: Vedolizumab;Drug: Adalimumab placebo;Drug: Adalimumab;Drug: Vedolizumab placebo

Takeda

NULL

Completed

18 Years

85 Years

All

771

Phase 3

United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Chile;Czech Republic;Finland;Norway;South Africa;Sweden

592

NCT02435992
(ClinicalTrials.gov)

June 17, 2015

24/4/2015

Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: RPC1063;Drug: Placebo

Celgene

NULL

Completed

12 Years

75 Years

All

1012

Phase 3

United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic

593

JPRN-JapicCTI-163122

28/5/2015

06/01/2016

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative, Inflammatory Bowel Diseases

Intervention name : Ustekinumab
Dosage And administration of the intervention : week 0: Participants will be randomized to receive single dose of placebo, Ustekinumab 130mg or Ustekinumab 6 mg/kg as Intravenous (IV: into the vein) infusion at Week 0. At week 8: Participants without clinical response to placebo will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo. Participants without clinical response to ustekinumab (130 mg or 6 mg/kg [IV]) will receive a single dose of ustekinumab 90 mg SC along with matching placebo IV. Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized. Participants in clinical response will be randomized to receive placebo SC, ustekinumab 90 mg SC every 12 weeks or 90 mg subcutaneously every 8 weeks beginning Week 0 of Maintenance study through Week 44.

Janssen Pharmaceutical K.K.

NULL

complete

BOTH

Phase 3

NULL

594

EUCTR2014-000784-41-DK
(EUCTR)

15/04/2015

28/01/2015

Amino acids in j-pouch surgery for ulcerative colitis

Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis

Ileal pouch-anal anastomosis for ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Vaminolac, komb.
Product Name: Vaminolac, komb.
INN or Proposed INN: Vaminolac, komb.
Other descriptive name: Vaminolac, komb.

Department of Medicine and Endocrinology

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Denmark

595

EUCTR2013-001205-84-SK
(EUCTR)

23/03/2015

05/02/2015

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

596

NCT02368717
(ClinicalTrials.gov)

March 2015

16/2/2015

An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase

A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets

Ulcerative Colitis

Drug: Mesalazine Enema;Drug: Placebo Enema

Ferring Pharmaceuticals

NULL

Completed

18 Years

70 Years

All

281

Phase 3

China

597

EUCTR2013-001205-84-LV
(EUCTR)

26/02/2015

23/12/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands

598

EUCTR2013-001205-84-PL
(EUCTR)

20/01/2015

22/09/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands

599

EUCTR2014-001893-32-PL
(EUCTR)

20/01/2015

22/10/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Belgium;Poland;Russian Federation;Germany

600

EUCTR2014-001893-32-CZ
(EUCTR)

19/01/2015

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

601

EUCTR2013-001205-84-DE
(EUCTR)

13/01/2015

08/08/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis

Maintenance of remission in ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

602

EUCTR2013-004279-11-BG
(EUCTR)

12/01/2015

06/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

603

EUCTR2013-004277-27-BG
(EUCTR)

12/01/2015

06/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

604

NCT02289417
(ClinicalTrials.gov)

January 8, 2015

10/11/2014

Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis

A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Apremilast;Drug: Placebo

Amgen

NULL

Completed

18 Years

N/A

All

170

Phase 2

United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic

605

NCT02136069
(ClinicalTrials.gov)

December 24, 2014

15/4/2014

A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

Ulcerative Colitis

Drug: Etrolizumab;Drug: Infliximab;Other: Placebo (IV);Other: Placebo (Injection)

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

397

Phase 3

Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Portugal;Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Philippines;Vietnam

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

606

JPRN-JapicCTI-142649

22/12/2014

03/09/2014

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290]

Ulcerateive Colotis

Intervention name : abalimumab
INN of the intervention : Adalimumab
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : subcutaneous injection

AbbVie GK

NULL

complete

BOTH

Phase 3

Japan, Europe

607

EUCTR2014-004740-35-DK
(EUCTR)

19/12/2014

25/11/2014

Loperamide vs. Placebo's effect on Ileostomy output

Loperamide vs. Placebo's effect on ileostomy output: A clincal randomized patientblinded crossover study

Patients with ileostomy because of ulcerative colitis, rectal cancer or short bowel syndrom
MedDRA version: 17.1;Level: LLT;Classification code 10012727;Term: Diarrhea;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Imolope
Product Name: Imolope
Product Code: A07DA03
INN or Proposed INN: LOPERAMIDE

Department of surgery, Odense University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Denmark

608

EUCTR2013-004280-31-DK
(EUCTR)

17/12/2014

29/07/2014

PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMABCOMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - Laurel

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Hungary;Czech Republic;Slovakia;Canada;Poland;Denmark;South Africa;Israel;Germany

609

EUCTR2014-001893-32-DE
(EUCTR)

15/12/2014

24/09/2014

Placebo-controlled study to assess efficacy, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany

610

EUCTR2013-004277-27-GR
(EUCTR)

08/12/2014

Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Brazil;Malaysia;Poland;Croatia;Australia;Bulgaria;Latvia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

611

EUCTR2014-001893-32-HU
(EUCTR)

08/12/2014

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany

612

EUCTR2013-003032-77-HU
(EUCTR)

04/12/2014

30/12/2013

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

AbbVie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;New Zealand

613

NCT02337608
(ClinicalTrials.gov)

December 2014

9/1/2015

Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis

Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: GLPG1205;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

75 Years

Both

Phase 2

Belgium;Czech Republic;Germany;Hungary;Poland;Russian Federation

614

EUCTR2013-004280-31-DE
(EUCTR)

24/11/2014

30/07/2014

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

615

EUCTR2014-001893-32-BE
(EUCTR)

24/11/2014

18/09/2014

Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis

Product Name: GLPG1205
Product Code: G321605
Other descriptive name: GLPG1205

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Czech Republic;Poland;Belgium;Russian Federation;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

616

EUCTR2013-004278-88-BE
(EUCTR)

21/11/2014

10/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

Phase 3

617

EUCTR2013-004278-88-NL
(EUCTR)

19/11/2014

23/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta 7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of

618

NCT02171429
(ClinicalTrials.gov)

November 14, 2014

20/6/2014

A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2)

Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

Ulcerative Colitis

Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

358

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Czechia;Greece;Hungary;Latvia;Lithuania;Malaysia;New Zealand;Poland;Russian Federation;Turkey;Ukraine

619

EUCTR2013-004279-11-SK
(EUCTR)

13/11/2014

08/10/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

Serbia;United States;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

620

NCT02163759
(ClinicalTrials.gov)

November 4, 2014

12/6/2014

Ulcerative Colitis

Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

358

Phase 3

United States;Argentina;Australia;Brazil;Bulgaria;Estonia;France;Hong Kong;Mexico;Poland;Russian Federation;Serbia;Slovakia;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

621

JPRN-JapicCTI-142704

01/11/2014

14/11/2014

Phase III study of AJG511 in patients with active ulcerative colitis

ulcerative colitis

Intervention name : AJG511
INN of the intervention : budesonide
Dosage And administration of the intervention : intrarectal
Control intervention name : Placebo
Dosage And administration of the control intervention : intrarectal

EA Pharma Co.,Ltd.

NULL

BOTH

120

Phase 3

NULL

622

NCT02361957
(ClinicalTrials.gov)

November 2014

15/1/2015

The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients

Ulcerative Colitis

Dietary Supplement: Ecologic 825;Dietary Supplement: Placebo

Wageningen University

NULL

Suspended

18 Years

65 Years

Both

N/A

Netherlands

623

NCT02246686
(ClinicalTrials.gov)

November 2014

19/9/2014

Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis

Colitis, Ulcerative

Drug: STW5-II (Iberogast N, BAY98-7410);Drug: Placebo

Bayer

NULL

Terminated

18 Years

80 Years

Both

Phase 2

Germany

624

EUCTR2012-003702-27-BE
(EUCTR)

21/10/2014

04/02/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC

Acute Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia

625

EUCTR2013-004278-88-DE
(EUCTR)

20/10/2014

06/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

626

NCT02065557
(ClinicalTrials.gov)

October 13, 2014

17/2/2014

Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Biological: Adalimumab;Biological: Placebo

AbbVie

NULL

Completed

4 Years

17 Years

All

101

Phase 3

United States;Australia;Austria;Belgium;Canada;Czechia;Hungary;Israel;Japan;New Zealand;Poland;Slovakia;Spain;United Kingdom;Czech Republic;Italy;Sweden

627

EUCTR2013-004280-31-CZ
(EUCTR)

07/10/2014

21/07/2014

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

628

EUCTR2013-004279-11-EE
(EUCTR)

03/10/2014

09/09/2014

Product Name: Etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Serbia;Estonia;Hong Kong;Slovakia;Ukraine;Russian Federation;France;Mexico;Argentina;Brazil;Poland;Australia;Bulgaria

629

NCT02280629
(ClinicalTrials.gov)

October 1, 2014

29/10/2014

Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2)

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis

Ulcerative Colitis

Drug: LT-02;Drug: Placebo;Drug: Mesalamine

Dr. Falk Pharma GmbH

NULL

Completed

18 Years

70 Years

All

150

Phase 3

Germany

630

NCT02266849
(ClinicalTrials.gov)

October 2014

8/10/2014

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study

Rectal Cancer;Ulcerative Colitis;Short Bowel Syndrome

Drug: Loperamide;Drug: Placebo

Odense University Hospital

NULL

Terminated

18 Years

N/A

Both

Phase 3

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

631

EUCTR2013-004277-27-LT
(EUCTR)

30/09/2014

22/07/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

632

EUCTR2012-003702-27-NL
(EUCTR)

30/09/2014

14/04/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia

633

EUCTR2013-004278-88-GR
(EUCTR)

22/09/2014

03/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

634

EUCTR2013-004280-31-HU
(EUCTR)

19/09/2014

31/07/2014

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

350

Phase 3

United States;Slovakia;Ukraine;Israel;Italy;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany

635

EUCTR2013-003032-77-IT
(EUCTR)

10/09/2014

19/12/2013

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use
Product Name: ADALIMUMAB
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

636

EUCTR2013-004278-88-FR
(EUCTR)

04/09/2014

22/06/2015

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

637

EUCTR2013-000263-88-RO
(EUCTR)

03/09/2014

30/05/2014

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: JNJ-54781532-AAD-5 mg
INN or Proposed INN: Not available
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-10 mg
INN or Proposed INN: Not available
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-30 mg
INN or Proposed INN: Not available
Other descriptive name: ASP015K

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 2b

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

638

EUCTR2013-004278-88-IT
(EUCTR)

01/09/2014

01/07/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
Other descriptive name: ETROLIZUMAB

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

639

EUCTR2013-003032-77-BE
(EUCTR)

25/08/2014

02/01/2014

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

640

EUCTR2013-004278-88-DK
(EUCTR)

21/08/2014

10/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previouslyexposed to TNF inhibitors.

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

800

Phase 3

Hungary;United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

641

NCT02165215
(ClinicalTrials.gov)

August 12, 2014

13/6/2014

A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors

Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

Colitis, Ulcerative

Drug: Etrolizumab;Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

359

Phase 3

United States;Brazil;Canada;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Slovakia;South Africa;Ukraine;Czech Republic

642

EUCTR2013-004277-27-HR
(EUCTR)

12/08/2014

05/09/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

643

EUCTR2013-004278-88-HU
(EUCTR)

04/08/2014

10/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

605

Phase 3

644

EUCTR2012-003702-27-PL
(EUCTR)

29/07/2014

20/05/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands

645

EUCTR2013-004277-27-LV
(EUCTR)

28/07/2014

21/07/2014

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 3

United States;Greece;Ukraine;Turkey;Lithuania;Russian Federation;Colombia;Czech Republic;Hungary;Argentina;Poland;Brazil;Malaysia;Croatia;Australia;Bulgaria;Latvia;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

646

EUCTR2013-004278-88-ES
(EUCTR)

25/07/2014

13/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who are not responding to treatment with or are intolerant to TNF inhibitors.

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: -
Other descriptive name: ETROLIZUMAB

Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

800

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of

647

JPRN-JapicCTI-142648

22/7/2014

03/09/2014

Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033]

Ulcerative Colitis

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : subcutaneous injection

AbbVie GK

NULL

complete

BOTH

100

Phase 3

Japan, North America, Europe

648

NCT02142725
(ClinicalTrials.gov)

July 21, 2014

15/5/2014

Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 12-weeks add-on Treatment With LT 02 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine

Ulcerative Colitis

Drug: LT-02;Drug: Placebo

Dr. Falk Pharma GmbH

NULL

Terminated

18 Years

70 Years

All

468

Phase 3

Germany

649

EUCTR2013-000891-13-DE
(EUCTR)

21/07/2014

24/06/2014

Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)

A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits

Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Iberogast N
Product Name: Iberogast N
Product Code: STW5-II
INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml
Other descriptive name: BITTER CANDYTUFT FRESH PLANT EXTRACT
INN or Proposed INN: Kümmel 2ml/10ml
Other descriptive name: CARVI EXTRACTUM FLUIDUM
INN or Proposed INN: Pfefferminzblätter 1ml/10ml
Other descriptive name: MENTHA × PIPERITA L. FOLIUM
INN or Proposed INN: Süßholzwurzel 1ml/10ml
Other descriptive name: GLYCYRRHIZA GLABRA ROOT
INN or Proposed INN: Kamillenblüten 3ml/10ml
Other descriptive name: MATRICARIA RECUTITA L. FLOS
INN or Proposed INN: Melissenblätter 15ml/10ml
Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT

Steigerwald Arzneimittelwerk GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Germany

650

EUCTR2013-004278-88-CZ
(EUCTR)

09/07/2014

09/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

Ulcerative colitis (UC)
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

651

EUCTR2013-004278-88-AT
(EUCTR)

02/07/2014

11/06/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: Etrolizumab
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

Spain;United States;Greece;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;Korea, Republic of

652

EUCTR2013-004278-88-LT
(EUCTR)

19/06/2014

24/04/2014

A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors.

PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY

Product Name: etrolizumab
Product Code: Ro 549-0261/F04
INN or Proposed INN: ETROLIZUMAB
Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

605

Phase 3

United States;Greece;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of

653

EUCTR2013-003060-31-BG
(EUCTR)

18/06/2014

10/04/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4)

Ulcerative Colitis (UC)
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

654

EUCTR2013-003060-31-PL
(EUCTR)

11/06/2014

19/03/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

655

EUCTR2012-003702-27-SK
(EUCTR)

10/06/2014

06/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

656

NCT02179372
(ClinicalTrials.gov)

June 2014

29/6/2014

Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases

Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases

Ulcerative Colitis;Crohn's Disease

Dietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo)

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

NULL

Completed

18 Years

80 Years

Both

N/A

Italy

657

NCT02100696
(ClinicalTrials.gov)

May 21, 2014

27/3/2014

A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors

Ulcerative Colitis

Drug: Etrozulimab;Drug: Placebo

Hoffmann-La Roche

NULL

Completed

18 Years

80 Years

All

609

Phase 3

United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Spain;Switzerland;United Kingdom;Czech Republic;New Zealand

658

EUCTR2012-003702-27-LV
(EUCTR)

20/05/2014

25/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany

659

EUCTR2012-003702-27-HU
(EUCTR)

19/05/2014

07/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands

660

EUCTR2012-003702-27-CZ
(EUCTR)

15/05/2014

24/02/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: Gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

661

EUCTR2012-003702-27-LT
(EUCTR)

12/05/2014

19/03/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia

662

EUCTR2012-003702-27-DE
(EUCTR)

08/05/2014

30/12/2013

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Acute Ulcerative Colitis (UC)
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands

663

EUCTR2013-004599-36-DE
(EUCTR)

23/04/2014

03/02/2014

SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily

SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE

Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Product Name: SB012
INN or Proposed INN: hgd40

sterna biologicals GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Germany

664

EUCTR2013-000263-88-BG
(EUCTR)

14/04/2014

17/02/2014

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Product Name: JNJ-54781532-AAD-5 mg
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-10 mg
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-30 mg
Other descriptive name: ASP015K

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

665

EUCTR2013-003060-31-CZ
(EUCTR)

10/04/2014

04/02/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

666

EUCTR2012-002030-37-HR
(EUCTR)

09/04/2014

14/10/2014

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Product Code: PF-00547659
INN or Proposed INN: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden

667

EUCTR2013-003060-31-HU
(EUCTR)

02/04/2014

31/01/2014

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia

668

EUCTR2012-003702-27-AT
(EUCTR)

02/04/2014

10/02/2014

LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis

Product Name: gastro-resistant phosphatidylcholine granules
Product Code: LT-02
INN or Proposed INN: Phosphatidylcholine
Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE

Dr. Falk Pharma GmbH

NULL

Not Recruiting

Female: yes
Male: yes

762

Phase 3

Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia

669

NCT02129439
(ClinicalTrials.gov)

April 2014

30/4/2014

Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients

SB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered OD

Colitis, Ulcerative

Drug: SB012;Drug: Placebo

Sterna Biologicals GmbH & Co. KG

NULL

Completed

18 Years

75 Years

All

Phase 1;Phase 2

Germany

670

EUCTR2011-005251-13-EE
(EUCTR)

31/03/2014

15/01/2014

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

United States;Estonia;Greece;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Latvia;Netherlands;Norway;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

671

NCT02065622
(ClinicalTrials.gov)

March 27, 2014

17/2/2014

Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)

Drug: Adalimumab;Other: Placebo

AbbVie

NULL

Completed

18 Years

75 Years

All

952

Phase 3

United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic

672

EUCTR2013-003032-77-ES
(EUCTR)

25/03/2014

27/02/2014

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

673

EUCTR2011-005251-13-LV
(EUCTR)

03/03/2014

16/01/2014

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

674

EUCTR2013-003060-31-LV
(EUCTR)

17/02/2014

16/12/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

675

EUCTR2013-003060-31-LT
(EUCTR)

11/02/2014

30/12/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

676

JPRN-JapicCTI-142403

04/2/2014

27/12/2013

Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis

Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitis

Ulcerative colitis

Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase.
Intervention name : MLN0002 (Vedolizumab)
INN of the intervention : Vedolizumab
Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in

TAKEDA PHARMACEUTICAL COMPANY LTD.

NULL

complete

BOTH

292

Phase 3

Japan

677

NCT02039505
(ClinicalTrials.gov)

February 4, 2014

16/1/2014

Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis

Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis

Ulcerative Colitis

Drug: Vedolizumab;Drug: Vedolizumab placebo

Takeda

NULL

Completed

15 Years

80 Years

All

292

Phase 3

Japan

678

EUCTR2013-000263-88-PL
(EUCTR)

29/01/2014

26/11/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Ulcerative Colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: JNJ-54781532-AAD-5 mg
INN or Proposed INN: Not Assigned
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-10 mg
INN or Proposed INN: Not Assigned
Other descriptive name: ASP015K
Product Name: JNJ-54781532-AAD-30 mg
INN or Proposed INN: Not Assigned
Other descriptive name: ASP015K

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands

679

EUCTR2013-000263-88-NL
(EUCTR)

23/01/2014

21/11/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

United States;France;Hungary;Canada;Belgium;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;Netherlands

680

EUCTR2013-000263-88-HU
(EUCTR)

16/01/2014

21/11/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

681

EUCTR2013-000263-88-BE
(EUCTR)

08/01/2014

29/10/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2b

United States;Ukraine;Russian Federation;Israel;France;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands

682

EUCTR2013-000263-88-DE
(EUCTR)

07/01/2014

14/10/2013

A study to evaluate the dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

France;United States;Hungary;Canada;Poland;Belgium;Ukraine;Romania;Russian Federation;Bulgaria;Netherlands;Germany

683

EUCTR2013-002116-27-BG
(EUCTR)

19/12/2013

16/10/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia

684

NCT01959165
(ClinicalTrials.gov)

November 21, 2013

8/10/2013

MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients

Ulcerative Colitis

Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo

AstraZeneca

NULL

Completed

18 Years

65 Years

All

Phase 2

Japan

685

NCT01959282
(ClinicalTrials.gov)

November 15, 2013

7/10/2013

A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Placebo;Drug: JNJ-54781532 25 mg once daily;Drug: JNJ-54781532 75 mg once daily;Drug: JNJ-54781532 150 mg once daily;Drug: JNJ-54781532 75 mg twice daily

Janssen Research & Development, LLC

NULL

Completed

18 Years

N/A

All

219

Phase 2

United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

686

EUCTR2013-002116-27-LT
(EUCTR)

14/11/2013

06/08/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Ulcerative Colitis (UC)
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

687

NCT01896635
(ClinicalTrials.gov)

November 2013

6/7/2013

Faecal Microbiota Transplantation in Ulcerative Colitis

Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety

Ulcerative Colitis;Inflammatory Bowel Disease

Biological: FMT infusions;Other: Placebo infusion

The University of New South Wales

NULL

Completed

18 Years

75 Years

Both

Phase 2

Australia

688

NCT01953354
(ClinicalTrials.gov)

November 2013

24/9/2013

Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis

A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota

Colitis, Ulcerative

Biological: Trichuris suis ova (TSO);Biological: Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Coronado Biosciences, Inc.;Autoimmunity Centers of Excellence

Terminated

18 Years

70 Years

All

Phase 2

United States

689

EUCTR2012-003123-38-NL
(EUCTR)

29/10/2013

27/05/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

690

EUCTR2013-002116-27-LV
(EUCTR)

28/10/2013

26/06/2013

A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

691

EUCTR2013-002116-27-HU
(EUCTR)

24/10/2013

24/07/2013

A Placebo Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

692

EUCTR2013-002116-27-CZ
(EUCTR)

09/10/2013

08/08/2013

A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind,Placebo-Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis (NATRUL-3)

Nutrition Science Partners Limited

NULL

Not Recruiting

Female: yes
Male: yes

420

Phase 3

United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;Korea, Republic of

693

EUCTR2012-002030-37-BG
(EUCTR)

03/10/2013

24/09/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

694

EUCTR2012-002030-37-DE
(EUCTR)

27/09/2013

22/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Ulcerative Colitis (UC)
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
INN or Proposed INN: not available
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

695

EUCTR2012-002013-19-DE
(EUCTR)

25/09/2013

17/05/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

France;United States;Canada;Belgium;Poland;Austria;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

696

EUCTR2012-002013-19-PL
(EUCTR)

12/09/2013

14/06/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

France;United States;Canada;Belgium;Poland;Austria;Germany;Italy

697

EUCTR2011-003208-19-CZ
(EUCTR)

05/09/2013

03/04/2013

GWP42003 symptomatic treatment of ulcerative colitis.

A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.

Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: GWP42003
INN or Proposed INN: Not Applicable
Other descriptive name: CANNABIDIOL

GW Pharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;United Kingdom

698

EUCTR2011-004579-35-HR
(EUCTR)

27/08/2013

28/08/2014

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand

699

EUCTR2011-004580-79-HR
(EUCTR)

26/08/2013

28/08/2014

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

700

EUCTR2011-004578-27-HR
(EUCTR)

26/08/2013

28/08/2014

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

701

EUCTR2012-002013-19-BE
(EUCTR)

19/07/2013

19/02/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Canada;Poland;Belgium;Austria;Germany;Italy

702

EUCTR2012-002030-37-ES
(EUCTR)

04/07/2013

10/06/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
INN or Proposed INN: .
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

United States;Serbia;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Norway;Germany;New Zealand;Sweden

703

EUCTR2012-002030-37-HU
(EUCTR)

27/06/2013

15/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;United States;Slovakia;Spain;Russian Federation;Israel;Italy;France;Australia;Denmark;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany;Norway;New Zealand;Sweden

704

EUCTR2012-003123-38-GR
(EUCTR)

25/06/2013

10/05/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Receptos, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

180

Phase 2

United States;Slovakia;Greece;Russian Federation;Israel;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Germany;New Zealand;Korea, Republic of

705

EUCTR2012-002030-37-AT
(EUCTR)

11/06/2013

29/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
INN or Proposed INN: not available
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

706

EUCTR2012-002013-19-IT
(EUCTR)

02/06/2013

08/04/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

United States;France;Canada;Poland;Belgium;Austria;Germany;Italy

707

NCT01882764
(ClinicalTrials.gov)

June 2013

17/6/2013

HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis

A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis With Clinical Remission or Response From Induction Therapy. (NATRUL-4)

Ulcerative Colitis

Drug: HMPL-004;Drug: Placebo

Hutchison Medipharma Limited

Nutrition Science Partners Limited

Terminated

18 Years

N/A

All

Phase 3

United States

708

EUCTR2012-002030-37-SE
(EUCTR)

31/05/2013

27/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

709

EUCTR2012-002030-37-CZ
(EUCTR)

30/05/2013

16/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

710

EUCTR2012-005521-73-CZ
(EUCTR)

16/05/2013

01/03/2013

Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis

Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0974
INN or Proposed INN: GLPG0974

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

711

EUCTR2012-002030-37-NL
(EUCTR)

15/05/2013

12/02/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
INN or Proposed INN: Not applicable
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

712

EUCTR2012-002030-37-PL
(EUCTR)

07/05/2013

12/04/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

713

EUCTR2012-002030-37-SK
(EUCTR)

02/05/2013

09/05/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

714

EUCTR2012-005521-73-LV
(EUCTR)

29/04/2013

13/03/2013

Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis

Product Name: GLPG0974
INN or Proposed INN: GLPG0974

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Latvia

715

EUCTR2012-003123-38-BG
(EUCTR)

24/04/2013

05/03/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

716

EUCTR2011-005251-13-PL
(EUCTR)

23/04/2013

10/01/2013

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

717

EUCTR2012-002030-37-IT
(EUCTR)

20/04/2013

02/04/2013

Study to test whether PF-00547659 is safe and improves symptoms in patients with UC

Ulcerative Colitis (UC)
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
INN or Proposed INN: NA
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc, 235 East 42nd Street, New York, NY10017, United States

NULL

Not Recruiting

Female: yes
Male: yes

300

718

EUCTR2012-002013-19-AT
(EUCTR)

16/04/2013

21/03/2013

Efficacy and Safety of SAR339658 in Patients with Moderate to Severe Ulcerative Colitis

A randomized, double-blind, placebo-controlled, multicenter study evaluating efficacy and safety of SAR339658 in patients with active moderate to severe Ulcerative Colitis (UC). - FUSCIA

Product Code: SAR339658
INN or Proposed INN: Vatelizumab

Sanofi aventis Recherche&Développement

NULL

Not Recruiting

Female: yes
Male: yes

France;United States;Canada;Belgium;Poland;Austria;Germany;Italy

719

NCT01829321
(ClinicalTrials.gov)

April 2013

9/4/2013

Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis

Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of GLPG0974 in Subjects With Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: GLPG0974;Drug: Placebo

Galapagos NV

NULL

Completed

18 Years

75 Years

Both

Phase 2

Belgium;Czech Republic;Latvia;Slovakia

720

NCT01846026
(ClinicalTrials.gov)

April 2013

30/4/2013

Ulcerative Colitis and Vitamin D Supplementation

Immunomodulating and Clinical Effects of Vitamin D on Remission Induction in Patients With Moderate and Severe Ulcerative Colitis, Undergoing Treatment With Infliximab.

Ulcerative Colitis

Drug: Vitamin D;Drug: placebo

University Hospital of North Norway

NULL

Withdrawn

18 Years

N/A

Both

Phase 1;Phase 2

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

721

EUCTR2012-005521-73-BE
(EUCTR)

20/03/2013

08/02/2013

Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 16.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GLPG0974
INN or Proposed INN: GLPG0974

Galapagos NV

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Belgium;Latvia

722

NCT01863771
(ClinicalTrials.gov)

March 15, 2013

23/5/2013

A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Drug: Golimumab;Other: Placebo

Janssen Pharmaceutical K.K.

NULL

Completed

18 Years

70 Years

All

144

Phase 3

Japan

723

EUCTR2011-004578-27-NL
(EUCTR)

04/03/2013

12/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada

724

NCT01831427
(ClinicalTrials.gov)

March 2013

8/4/2013

Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis

A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: GS-5745;Drug: Placebo to match GS-5745

Gilead Sciences

NULL

Completed

18 Years

65 Years

All

Phase 1

United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania

725

NCT01810185
(ClinicalTrials.gov)

March 2013

11/3/2013

Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease

Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis

Drug: Low dose naltrexone;Drug: Placebo

Santa Barbara Cottage Hospital

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

726

NCT01805791
(ClinicalTrials.gov)

March 2013

4/3/2013

A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis

Ulcerative Colitis

Drug: HMPL-004 1800 mg/day;Drug: Placebo;Drug: HMPL-004 2400 mg/day

Hutchison Medipharma Limited

NULL

Terminated

18 Years

75 Years

All

201

Phase 3

United States

727

EUCTR2012-003123-38-HU
(EUCTR)

12/02/2013

04/12/2012

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

113

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

728

EUCTR2012-003123-38-PL
(EUCTR)

10/02/2013

15/01/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Netherlands;Korea, Republic of

729

NCT01658605
(ClinicalTrials.gov)

February 2013

24/5/2012

A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis

A Phase II, 20-week, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Proof of Concept Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis

Colitis, Ulcerative

Drug: GSK1605786;Other: Placebo

GlaxoSmithKline

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

Belgium;Netherlands;United Kingdom

730

NCT01759056
(ClinicalTrials.gov)

February 2013

24/12/2012

Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis

A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: AVX 470;Drug: Placebo

Avaxia Biologics, Incorporated

NULL

Completed

18 Years

75 Years

Both

Phase 1

United States;Belgium;Canada;Hungary

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

731

EUCTR2012-003123-38-SK
(EUCTR)

28/01/2013

04/03/2013

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II).

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

732

EUCTR2011-004578-27-IT
(EUCTR)

18/01/2013

07/08/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulverative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

PFIZER INC.

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Croatia;Germany;Japan

733

EUCTR2011-004580-79-IT
(EUCTR)

18/01/2013

07/08/2012

maintenance therapy with CP-690,550 in subjects with ulcerative colitis

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

ulcerative colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib
Product Name: NA
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

PFIZER LIMITED

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

654

United States;Taiwan;Estonia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;Australia;Denmark;South Africa;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Croatia;Germany;New Zealand;Japan

734

EUCTR2012-003974-18-BG
(EUCTR)

18/01/2013

07/11/2012

A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: VB-201
INN or Proposed INN: Not applicable

Vascular Biogenics Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

110

Hungary;Bulgaria

735

EUCTR2011-001568-22-HU
(EUCTR)

15/01/2013

18/07/2012

A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Recombinant Factor XIII (rFXIII)
INN or Proposed INN: Catridecacog

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

736

EUCTR2011-005251-13-NL
(EUCTR)

08/01/2013

23/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Estonia;Greece;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

737

EUCTR2012-002030-37-BE
(EUCTR)

08/01/2013

05/09/2012

A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT) - TURANDOT

Crohn’s Disease (CD) and Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: PF-00547659
Other descriptive name: Anti-MAdCAM antibody

Pfizer Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Serbia;Slovakia;Spain;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Brazil;Croatia;Denmark;Australia;Bulgaria;South Africa;Netherlands;Germany;Norway;Sweden

738

NCT01839214
(ClinicalTrials.gov)

January 2013

21/4/2013

A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis

Ulcerative Colitis

Drug: VB-201 160mg;Drug: Placebo

Vascular Biogenics Ltd. operating as VBL Therapeutics

NULL

Completed

18 Years

N/A

Both

112

Phase 2

Bulgaria;Hungary;Poland

739

NCT01647516
(ClinicalTrials.gov)

December 26, 2012

19/7/2012

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Drug: Ozanimod;Drug: Placebo

Celgene

NULL

Completed

18 Years

73 Years

All

199

Phase 2

United States;Australia;Belgium;Bulgaria;Canada;Greece;Hungary;Israel;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Ukraine

740

EUCTR2011-005251-13-DE
(EUCTR)

21/12/2012

09/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 20.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Latvia;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

741

EUCTR2012-003123-38-BE
(EUCTR)

11/12/2012

10/10/2012

A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Moderately to severely active Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of

742

EUCTR2012-003974-18-HU
(EUCTR)

10/12/2012

28/09/2012

Study to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis

Product Code: VB-201
INN or Proposed INN: Not applicable

Vascular Biogenics Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

110

Hungary;Bulgaria

743

NCT01078935
(ClinicalTrials.gov)

December 2012

1/3/2010

The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

The Effect of Probiotics on Bowel Disease

Crohn's Disease;Ulcerative Colitis

Dietary Supplement: probiotics;Dietary Supplement: placebo

The Baruch Padeh Medical Center, Poriya

Ministry of Health, Israel

Not yet recruiting

18 Years

80 Years

Both

100

Phase 4

NULL

744

EUCTR2011-002462-20-SK
(EUCTR)

19/11/2012

27/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study

Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 20 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 50 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate
Product Name: KdPT
Product Code: 100 mg
Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Slovakia;Poland;Germany;Italy

745

NCT01694485
(ClinicalTrials.gov)

November 16, 2012

24/9/2012

Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis

A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Biological: Abrilumab;Drug: Placebo

Amgen

NULL

Completed

18 Years

65 Years

All

359

Phase 2

United States;Australia;Austria;Belgium;Canada;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;Italy;Latvia;Netherlands;Norway;Poland;Russian Federation;Switzerland;United Kingdom;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

746

NCT01620255
(ClinicalTrials.gov)

November 2012

13/6/2012

A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis

A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)

Ulcerative Colitis

Drug: Placebo;Drug: PF-00547659 SC Injection

Shire

NULL

Completed

18 Years

65 Years

All

357

Phase 2

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Croatia;Czech Republic;Norway;Sweden;United Kingdom

747

EUCTR2011-004579-35-NL
(EUCTR)

10/10/2012

12/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand

748

EUCTR2011-001568-22-BG
(EUCTR)

05/10/2012

16/08/2012

A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Recombinant Factor XIII (rFXIII)
INN or Proposed INN: Catridecacog

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;European Union;Ukraine;Croatia;Denmark;Russian Federation;Bulgaria

749

NCT01418131
(ClinicalTrials.gov)

October 2012

15/8/2011

Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis

A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis

Ulcerative Colitis

Drug: Rectal tacrolimus;Drug: Placebo

The University of Western Australia

Royal Brisbane and Women's Hospital;Royal Adelaide Hospital, Australia;Liverpool Hospital, Australia;Fremantle Hospital and Health Service

Completed

18 Years

N/A

Both

Phase 4

Australia

750

NCT01706159
(ClinicalTrials.gov)

October 2012

9/10/2012

A Placebo-controlled Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

A Multicenter, Randomised, Double-blind, Placebo-controlled, Multiple-dose Trial With rFXIII Administered to Subjects With Mild to Moderate Active Ulcerative Colitis

Inflammation;Ulcerative Colitis

Drug: catridecacog;Drug: placebo

Novo Nordisk A/S

NULL

Terminated

18 Years

64 Years

All

Phase 2

Bulgaria;Croatia;Denmark;Hungary;Poland;Russian Federation;Ukraine

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

751

EUCTR2011-004578-27-PL
(EUCTR)

18/09/2012

20/06/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan

752

EUCTR2011-004579-35-PL
(EUCTR)

17/09/2012

28/06/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand

753

EUCTR2011-005251-13-IT
(EUCTR)

16/09/2012

27/08/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG181
Product Code: AMG181

AMGEN INC.

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Poland;Belgium;Australia

754

EUCTR2011-005251-13-BE
(EUCTR)

14/09/2012

18/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Latvia;Germany;Netherlands;Norway

755

EUCTR2011-005115-82-LT
(EUCTR)

12/09/2012

24/05/2012

An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen

Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

756

EUCTR2011-005251-13-HU
(EUCTR)

11/09/2012

18/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Germany;Norway

757

EUCTR2011-005251-13-AT
(EUCTR)

10/09/2012

23/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

758

EUCTR2011-005251-13-GB
(EUCTR)

06/09/2012

13/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Latvia;Norway;Netherlands;Germany

759

EUCTR2011-004765-32-NL
(EUCTR)

27/08/2012

25/04/2012

Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST 261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis

Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PROPIONYL L-CARNITINE HYDROCHLORIDE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

444

Phase 3

Czech Republic;Belgium;Israel;Russian Federation;Netherlands;Italy

760

EUCTR2011-001568-22-DK
(EUCTR)

23/08/2012

02/08/2012

A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis

Mild to moderate Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Recombinant Factor XIII (rFXIII)
INN or Proposed INN: Catridecacog

Novo Nordisk A/S

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

761

EUCTR2011-005251-13-DK
(EUCTR)

16/08/2012

11/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Moderate to severe Ulcerative Colitis
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Australia;Latvia;Norway;Netherlands;Germany

762

EUCTR2011-004580-79-PL
(EUCTR)

05/08/2012

12/06/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Belgium;Poland;Romania;Croatia;Germany;New Zealand;Japan

763

NCT01670240
(ClinicalTrials.gov)

August 2012

8/8/2012

Adalimumab in the Treatment of Chronic Pouchitis

Adalimumab (Humira) in the Treatment of Chronic Pouchitis

Ulcerative Colitis;Pouchitis

Drug: Adalimumab;Drug: Placebo

Odense University Hospital

University of Southern Denmark;Hvidovre University Hospital;Aarhus University Hospital;AbbVie

Completed

18 Years

N/A

Both

Phase 3

Denmark

764

NCT01783119
(ClinicalTrials.gov)

August 2012

31/1/2013

Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis

Ulcerative Colitis

Dietary Supplement: Aloe Barbadensis Miller;Dietary Supplement: placebo water

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

NULL

Recruiting

18 Years

59 Years

Both

Phase 0

Mexico

765

NCT01659138
(ClinicalTrials.gov)

August 2012

3/8/2012

Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)

Ulcerative Colitis

Drug: SAR339658;Other: Placebo

Sanofi

NULL

Terminated

18 Years

70 Years

Both

Phase 2

United States;Austria;Canada;France;Germany;Italy;Poland;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

766

EUCTR2011-005251-13-CZ
(EUCTR)

26/07/2012

17/07/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 2

United States;Estonia;Greece;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Latvia;Netherlands;Norway;Germany

767

NCT01458574
(ClinicalTrials.gov)

July 20, 2012

21/10/2011

A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

Ulcerative Colitis

Drug: Placebo;Drug: CP690,550;Drug: CP -690,550

Pfizer

NULL

Completed

18 Years

N/A

All

593

Phase 3

United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom

768

EUCTR2011-004579-35-ES
(EUCTR)

11/07/2012

09/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

United States;Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;New Zealand

769

EUCTR2011-004578-27-ES
(EUCTR)

11/07/2012

09/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

770

NCT01640496
(ClinicalTrials.gov)

July 2012

11/7/2012

Vitamin D Treatment in Ulcerative Colitis

Ulcerative Colitis;Inflammatory Bowel Disease

Drug: Vitamin D3;Other: Placebo

University of Chicago

North Shore University Hospital

Withdrawn

18 Years

N/A

Both

N/A

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

771

NCT01612039
(ClinicalTrials.gov)

July 2012

1/6/2012

Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis

A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: ASP3291;Drug: Placebo

Telsar Pharma Inc.

NULL

Completed

18 Years

65 Years

Both

112

Phase 2

United States

772

EUCTR2011-004579-35-CZ
(EUCTR)

29/06/2012

08/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc

,NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

773

EUCTR2011-004578-27-CZ
(EUCTR)

29/06/2012

08/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc

,NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

774

EUCTR2011-004580-79-CZ
(EUCTR)

26/06/2012

08/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy

775

EUCTR2011-004770-28-AT
(EUCTR)

26/06/2012

15/02/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

Mild ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Levocarnitine propyl hydrochloride
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

776

EUCTR2011-005115-82-LV
(EUCTR)

15/06/2012

21/05/2012

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

777

EUCTR2010-022766-27-SK
(EUCTR)

11/06/2012

27/01/2012

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF MULTISTEM (PF-05285401) IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: MultiStem
Product Code: PF-05285401
Other descriptive name: Multistem
Product Name: MultiStem
Product Code: PF-05285401
Other descriptive name: Multistem
Trade Name: Promiten
Other descriptive name: DEXTRAN 1 FOR INJECTION

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Belgium;Poland;Italy;Sweden

778

EUCTR2011-004580-79-BE
(EUCTR)

08/06/2012

07/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

779

EUCTR2011-004579-35-BE
(EUCTR)

08/06/2012

08/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

780

EUCTR2011-004578-27-BE
(EUCTR)

06/06/2012

07/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

781

EUCTR2011-004580-79-DE
(EUCTR)

06/06/2012

28/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Germany;New Zealand;Japan;Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Brazil;Belgium;Romania;Croatia

782

EUCTR2011-005251-13-GR
(EUCTR)

05/06/2012

14/05/2012

A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis

A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis

Product Name: AMG 181
Product Code: AMG 181
INN or Proposed INN: AMG 181

Amgen Inc

NULL

Not Recruiting

Female: yes
Male: yes

315

Phase 2

United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway

783

EUCTR2011-005115-82-EE
(EUCTR)

05/06/2012

09/05/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

784

NCT01458951
(ClinicalTrials.gov)

June 2012

21/10/2011

A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis.

Ulcerative Colitis

Drug: tofacitinib;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

547

Phase 3

United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom

785

EUCTR2011-004578-27-HU
(EUCTR)

30/05/2012

10/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

786

EUCTR2011-004579-35-DE
(EUCTR)

29/05/2012

21/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

787

EUCTR2011-004579-35-LV
(EUCTR)

23/05/2012

01/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

788

EUCTR2011-004578-27-DE
(EUCTR)

23/05/2012

05/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not availble
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

789

EUCTR2011-004578-27-LV
(EUCTR)

23/05/2012

01/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

790

EUCTR2011-004580-79-LV
(EUCTR)

23/05/2012

01/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

791

EUCTR2011-004578-27-AT
(EUCTR)

18/05/2012

27/03/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

792

EUCTR2011-004580-79-AT
(EUCTR)

18/05/2012

27/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

793

EUCTR2011-004579-35-AT
(EUCTR)

18/05/2012

21/03/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
INN or Proposed INN: not available
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

794

EUCTR2011-004580-79-ES
(EUCTR)

18/05/2012

09/03/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Serbia;Taiwan;Estonia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan;New Zealand;United States

795

EUCTR2011-005115-82-BG
(EUCTR)

11/05/2012

11/04/2012

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

796

EUCTR2011-004580-79-HU
(EUCTR)

10/05/2012

10/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand;Japan

797

EUCTR2011-004579-35-HU
(EUCTR)

10/05/2012

10/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;New Zealand

798

NCT01562314
(ClinicalTrials.gov)

May 9, 2012

21/3/2012

A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160)

A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis

Ulcerative Colitis

Drug: GWP42003;Drug: Placebo

GW Research Ltd

NULL

Completed

18 Years

N/A

All

Phase 2

United Kingdom;Czech Republic

799

EUCTR2011-004770-28-DE
(EUCTR)

03/05/2012

09/02/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

Product Name: PROPIONYL L-CARNITINE
Product Code: ST 261
INN or Proposed INN: Propionylcarnitinhydrochlorid
Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Hungary;Poland;Spain;Lithuania;Austria;Latvia;Germany

800

EUCTR2011-004580-79-SK
(EUCTR)

03/05/2012

10/04/2013

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

801

EUCTR2011-004578-27-SK
(EUCTR)

02/05/2012

12/04/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

802

EUCTR2011-004579-35-SK
(EUCTR)

02/05/2012

13/04/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

803

EUCTR2011-004579-35-GB
(EUCTR)

01/05/2012

12/01/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

804

JPRN-UMIN000007593

2012/05/01

02/04/2012

Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial

Efficacy of Bifidobacterium Breve fermented milk in maintaining remission of ulcerative colitis: Randomized placebo-controlled trial - B-FLORA

ulcerative colitis

Bifidobacterium breve fermented milk
placebo

Public Health Research foundation

NULL

Complete: follow-up complete

20years-old

70years-old

Male and Female

600

Not applicable

Japan

805

EUCTR2011-004580-79-GB
(EUCTR)

30/04/2012

14/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

806

EUCTR2011-004580-79-EE
(EUCTR)

26/04/2012

13/02/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

807

EUCTR2011-004578-27-EE
(EUCTR)

26/04/2012

14/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

808

EUCTR2011-004578-27-GB
(EUCTR)

26/04/2012

12/01/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

809

EUCTR2011-004579-35-EE
(EUCTR)

26/04/2012

14/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

810

EUCTR2011-004765-32-IT
(EUCTR)

26/04/2012

23/07/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter, International Study to investigate the safety and efficacy of ST261 (Propionyl-L-Carnitine Hydrochloride) modified release tablets in Patients Affected by mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

SIGMA-TAU

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

Czech Republic;Belgium;Netherlands;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

811

EUCTR2010-023762-49-BE
(EUCTR)

23/04/2012

21/11/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS - IMA-638 Ulcerative Colitis Study

Ulcerative Colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

France;Belgium;United States;Hungary;Canada;Romania;Austria;Netherlands;Bulgaria;Spain;Germany;Poland

812

EUCTR2011-005115-82-CZ
(EUCTR)

18/04/2012

08/02/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

813

EUCTR2011-004812-40-GB
(EUCTR)

12/04/2012

21/03/2012

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2

Czech Republic;Netherlands;Germany;Italy;United Kingdom

814

EUCTR2011-004770-28-LT
(EUCTR)

12/04/2012

15/02/2012

Mild ulcerative colitis
MedDRA version: 16.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany

815

EUCTR2010-023588-16-DE
(EUCTR)

10/04/2012

05/05/2011

A study of a new iron medication for people with ulcerative colitis that is in remission and anaemia (low number of healthy red blood cells), who cannot use other oral iron medications either because they do not work, or because they cause side effects. (AEGIS 1)

A prospective, multicentre, randomised, double-blind, placebo controlled study with oral ST10-021 for the treatment of iron deficiency anaemia in subjects with quiescent ulcerative colitis where oral ferrous preparations have failed or cannot be used (AEGIS 1) - ST10-021 for IDA in quiescent UC

Iron deficiency anaemia in quiescent ulcerative colitis
MedDRA version: 17.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 17.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Product Name: ST10-021
Product Code: ST10-021
Other descriptive name: 3-hydroxy-2-methyl-4H-pyrane-4-one iron (III) complex (3:1), Ferric (3-hydroxy-2-methyl-4-pyrone), Tris-maltol-iron (III), Tri=maltol-iron (III)

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

816

EUCTR2011-005115-82-PL
(EUCTR)

10/04/2012

16/03/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

817

NCT01567956
(ClinicalTrials.gov)

April 2012

28/3/2012

Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis; Efficacy, Safety and Tolerability Study

Phase III Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

Ulcerative Colitis

Drug: Propionyl-L-Carnitine;Drug: Placebo

sigma-tau i.f.r. S.p.A.

PRA Health Sciences

Terminated

18 Years

75 Years

Both

150

Phase 3

Austria;France;Germany;Hungary;Latvia;Lithuania;Poland;Spain

818

NCT01465763
(ClinicalTrials.gov)

April 2012

21/10/2011

A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

Ulcerative Colitis

Drug: tofacitinib;Drug: Placebo

Pfizer

NULL

Completed

18 Years

N/A

All

614

Phase 3

United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Brazil

819

NCT01551290
(ClinicalTrials.gov)

April 2012

7/3/2012

A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab;Drug: Placebo

Xian-Janssen Pharmaceutical Ltd.

NULL

Completed

18 Years

65 Years

Both

Phase 3

China

820

NCT01538251
(ClinicalTrials.gov)

April 2012

20/2/2012

Efficacy, Safety and Tolerability of Propionyl-L-Carnitine Hydrochloride in Patients With Mild Ulcerative Colitis

Randomized Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine Hydrochloride Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis Under Oral Stable Treatment

Ulcerative Colitis

Drug: Propionyl-L-Carnitine;Drug: Placebo

sigma-tau i.f.r. S.p.A.

NULL

Terminated

18 Years

75 Years

Both

147

Phase 3

Belgium;Czech Republic;Israel;Italy;Netherlands;Romania;Russian Federation;Slovakia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

821

EUCTR2010-022766-27-IT
(EUCTR)

28/03/2012

27/04/2012

Study of safety and effectiveness of human-derived stem cells (multistem, also know as PF-05285401) in the treatment of ulcerative colitis.

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045282;Term: UC;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Multistem
Product Code: PF-05285401
Other descriptive name: Multistem
Product Name: Multistem
Product Code: PF-05285401
Other descriptive name: Multistem
Trade Name: Promiten
INN or Proposed INN: DEXTRAN 1 FOR INJECTION

PFIZER LIMITED

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Canada;Belgium;Italy;Sweden

822

EUCTR2011-005115-82-HU
(EUCTR)

26/03/2012

07/02/2012

Product Name: Budesonide -MMX®
INN or Proposed INN: BUDESONIDE

Santarus, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

500

United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia

823

EUCTR2011-004770-28-HU
(EUCTR)

21/03/2012

23/01/2012

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Hungary;Poland;Spain;Lithuania;Austria;Germany;Latvia

824

EUCTR2011-004770-28-PL
(EUCTR)

17/03/2012

16/02/2012

Mild ulcerative colitis
MedDRA version: 15.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

France;Hungary;Spain;Poland;Lithuania;Austria;Latvia;Germany

825

EUCTR2011-003130-14-IT
(EUCTR)

12/03/2012

05/03/2012

Clinical Trial to assess the efficacy and safety of Kappaproct

A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients” - CSUC-01/10

Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Kappaproct
Product Code: DIMS0150
INN or Proposed INN: NA
Other descriptive name: NA

INDEX PHARMACEUTICALS

NULL

Not Recruiting

Female: yes
Male: yes

132

Czech Republic;Hungary;Poland;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

826

NCT01482884
(ClinicalTrials.gov)

March 2012

29/11/2011

Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis

A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis

Ulcerative Colitis

Drug: tralokinumab;Drug: placebo

AstraZeneca

MedImmune Ltd

Completed

18 Years

65 Years

All

147

Phase 2

Czech Republic;France;Germany;Italy;Poland;United Kingdom;Netherlands

827

EUCTR2011-004770-28-LV
(EUCTR)

29/02/2012

24/01/2012

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

France;Hungary;Spain;Poland;Lithuania;Austria;Germany;Latvia

828

EUCTR2011-004770-28-ES
(EUCTR)

28/02/2012

11/01/2012

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

444

Phase 3

Hungary;Germany;France;Spain;Latvia;Poland;Austria;Lithuania

829

EUCTR2011-004579-35-DK
(EUCTR)

24/02/2012

A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Moderate to severe active Ulcerative Colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

830

EUCTR2011-004580-79-DK
(EUCTR)

24/02/2012

23/01/2012

A study of oral CP-690,550 as a maintenance therapy in subjects with ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

654

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

831

EUCTR2011-004578-27-DK
(EUCTR)

24/02/2012

09/02/2012

A study to investigate the efficacy of CP-690,550 in subjects with moderate to severe ulcerative colitis.

A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: CP -690,550-10
Product Code: CP -690,550-10
Other descriptive name: tofacitinib

Pfizer Inc, 235 East 42nd Street, New York, New York 10017

NULL

Not Recruiting

Female: yes
Male: yes

545

Phase 3

832

EUCTR2011-004765-32-CZ
(EUCTR)

21/02/2012

15/12/2011

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Czech Republic;Belgium;Netherlands;Italy

833

EUCTR2011-002818-37-BE
(EUCTR)

15/02/2012

03/10/2011

A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.

A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis.

Subjects with Active Ulcerative Colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands;United Kingdom

834

EUCTR2011-003532-32-LT
(EUCTR)

14/02/2012

28/11/2011

A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis

Acute mild to moderate ulcerative colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: LX1606
Product Code: LX1606
INN or Proposed INN: Telotristat etiprate
Other descriptive name: telotristat etiprate

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Poland;Belgium;Lithuania

835

EUCTR2010-022766-27-BE
(EUCTR)

09/02/2012

08/11/2011

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

Product Name: MultiStem
Product Code: PF-05285401
INN or Proposed INN: N/A
Other descriptive name: Multistem
Product Name: MultiStem
Product Code: PF-05285401
INN or Proposed INN: N/A
Other descriptive name: Multistem
Trade Name: Promiten
INN or Proposed INN: Dextran
Other descriptive name: DEXTRAN 1 FOR INJECTION

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Poland;Belgium;Germany;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

836

EUCTR2011-002818-37-GB
(EUCTR)

08/02/2012

07/11/2011

A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Netherlands;United Kingdom

837

EUCTR2010-022766-27-HU
(EUCTR)

07/02/2012

05/12/2011

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden

838

NCT01456052
(ClinicalTrials.gov)

January 30, 2012

17/10/2011

A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Telotristat Etiprate;Drug: Placebo

Lexicon Pharmaceuticals

NULL

Completed

18 Years

70 Years

All

Phase 2

United States;Lithuania;Poland;Slovakia

839

NCT01532648
(ClinicalTrials.gov)

January 27, 2012

13/12/2011

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen

Ulcerative Colitis

Drug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASA

Bausch Health Americas, Inc.

NULL

Completed

18 Years

75 Years

All

510

Phase 3

United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic

840

EUCTR2011-004812-40-DE
(EUCTR)

26/01/2012

25/11/2011

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

841

EUCTR2011-004812-40-NL
(EUCTR)

25/01/2012

22/12/2011

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

Ulcerative Colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;United Kingdom;Italy

842

EUCTR2011-004812-40-CZ
(EUCTR)

24/01/2012

29/12/2011

Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis.

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;United Kingdom;Italy

843

EUCTR2011-004765-32-SK
(EUCTR)

19/01/2012

09/12/2011

Mild ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

444

Phase 3

Czech Republic;Slovakia;Belgium;Netherlands;Italy

844

EUCTR2010-022766-27-SE
(EUCTR)

19/01/2012

03/11/2011

Study of safety and effectiveness of human-derived stem cells (multistem, also known as PF-05285401) in the treatment of ulcerative colitis

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

128

Phase 2

United States;Hungary;Slovakia;Canada;Belgium;Poland;Germany;Italy;Sweden

845

EUCTR2011-003130-14-CZ
(EUCTR)

13/01/2012

14/10/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Chronic active treatment refractory ulcerative colitis
MedDRA version: 16.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Kappaproct
INN or Proposed INN: DIMS0150
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Czech Republic;Poland;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

846

EUCTR2011-004765-32-BE
(EUCTR)

10/01/2012

06/12/2011

Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

NULL

Not Recruiting

Female: yes
Male: yes

444

Phase 3

Czech Republic;Slovakia;Belgium;Netherlands;Italy

847

EUCTR2010-023762-49-PL
(EUCTR)

06/01/2012

05/07/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

United States;France;Hungary;Canada;Spain;Belgium;Poland;Romania;Austria;Bulgaria;Germany;Netherlands

848

EUCTR2011-002818-37-NL
(EUCTR)

03/01/2012

16/02/2012

A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis.

Product Name: GSK1605786A
Product Code: GSK1605786A

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Netherlands;United Kingdom

849

EUCTR2011-002462-20-IT
(EUCTR)

02/01/2012

08/03/2012

Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis.

mild to moderate ulcerative colitis
MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Lysine -D-proline-threonine
Product Code: K(D)PT
INN or Proposed INN: NA
Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate

DR. AUGUST WOLFF GMBH & CO. KG

NULL

Not Recruiting

Female: yes
Male: yes

160

Hungary;Czech Republic;Slovakia;Poland;Germany;Italy

850

EUCTR2011-003130-14-DE
(EUCTR)

30/12/2011

19/09/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Product Name: Kappaproct
INN or Proposed INN: DIMS0150
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

851

EUCTR2011-002462-20-PL
(EUCTR)

27/12/2011

20/10/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Acute mild to moderate ulcerative colitis.
MedDRA version: 15.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

160

Hungary;Czech Republic;Poland;Germany;Italy

852

EUCTR2011-003130-14-PL
(EUCTR)

22/12/2011

10/10/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Product Name: Kappaproct
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

853

EUCTR2010-020448-37-NL
(EUCTR)

21/12/2011

16/09/2010

Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.

Active Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: PEG -liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE

Enceladus Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Belgium;Netherlands

854

EUCTR2011-003532-32-SK
(EUCTR)

19/12/2011

10/11/2011

A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis

Acute mild to moderate ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: LX1606
Product Code: LX1606
INN or Proposed INN: Non as of yet
Other descriptive name: telotristat etiprate

Lexicon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Slovakia;Belgium;Poland;Lithuania

855

EUCTR2011-004812-40-IT
(EUCTR)

12/12/2011

02/03/2012

Product Name: tralokinumab
Product Code: CAT-354
INN or Proposed INN: tralokinumab
Other descriptive name: NA

ASTRAZENECA

NULL

Not Recruiting

Female: yes
Male: yes

110

Phase 2a

Czech Republic;Netherlands;Germany;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

856

EUCTR2011-002462-20-HU
(EUCTR)

07/12/2011

22/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Hungary;Poland;Germany;Italy

857

NCT01493960
(ClinicalTrials.gov)

December 2011

12/12/2011

The Efficacy and Safety of Kappaproct in Chronic Active Treatment Refractory Ulcerative Colitis Patients

A Placebo-controlled, Double-blind, Randomised Study to Assess the Efficacy and Safety of Kappaproct as an add-on to Current Practice in Chronic Active Treatment Refractory Ulcerative Colitis Patients

Colitis, Ulcerative

Drug: Kappaproct;Drug: Placebo

InDex Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

131

Phase 3

Czech Republic;France;Germany;Hungary;Italy;Poland;United Kingdom

858

NCT01434576
(ClinicalTrials.gov)

December 2011

1/9/2011

Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative Colitis

Ulcerative Colitis

Biological: HGS1025;Drug: Placebo

Human Genome Sciences Inc.

NULL

Withdrawn

18 Years

N/A

Both

Phase 1

NULL

859

EUCTR2010-023762-49-DE
(EUCTR)

29/11/2011

17/08/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 17.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

France;United States;Hungary;Canada;Poland;Belgium;Spain;Romania;Austria;Bulgaria;Netherlands;Germany

860

EUCTR2011-002462-20-CZ
(EUCTR)

24/11/2011

20/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Acute mild to moderate ulcerative colitis.
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Poland;Germany;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

861

EUCTR2011-003208-19-GB
(EUCTR)

16/11/2011

28/09/2011

GWP42003 symptomatic treatment of ulcerative colitis.

A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis.

Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

GW Pharma Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;United Kingdom

862

EUCTR2010-023762-49-HU
(EUCTR)

09/11/2011

13/05/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

Hungary;Germany;Canada;Netherlands;Belgium;Romania;France;Bulgaria;Spain;United States;Poland;Austria

863

EUCTR2011-002462-20-DE
(EUCTR)

25/10/2011

13/09/2011

Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis

Dr August Wolff GmbH & Co KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

160

Hungary;Czech Republic;Poland;Germany;Italy

864

EUCTR2010-022506-41-PL
(EUCTR)

24/10/2011

05/09/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)Pharmacogenetics Blood Sample Amendment 01 - Site Specific (version 1.0, date 04-oct-2010)Revised Protocol 04 incorporating Protocol amendment 06

Colitis, Ulcerative
MedDRA version: 16.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Other descriptive name: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Australia;South Africa;Netherlands;Germany

865

EUCTR2011-000897-80-DE
(EUCTR)

19/10/2011

15/07/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Israel;Germany;United States;Hungary;Czech Republic;Canada;Spain;Australia;United Kingdom;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

866

EUCTR2011-003130-14-HU
(EUCTR)

14/10/2011

01/09/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Product Name: Kappaproct
Other descriptive name: DIMS0150

InDex Pharmaceuticals AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

867

EUCTR2011-003130-14-GB
(EUCTR)

06/10/2011

11/08/2011

A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment

Chronic active treatment refractory ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 3

Czech Republic;Hungary;Poland;Germany;Italy;United Kingdom

868

EUCTR2011-000897-80-ES
(EUCTR)

23/09/2011

04/07/2011

A clinical study to investigate the safety and efficacy of the productrhuMAb BETA7 in treating patients with ulcerative colitis, a form ofinflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDYTO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 INPATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

869

EUCTR2011-000897-80-CZ
(EUCTR)

14/09/2011

29/06/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

870

EUCTR2011-000897-80-GB
(EUCTR)

06/09/2011

29/06/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Australia;Israel;Germany;New Zealand;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

871

EUCTR2011-000897-80-HU
(EUCTR)

05/09/2011

07/09/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Czech Republic;Hungary;Canada;Spain;Australia;Israel;Germany;United Kingdom;New Zealand

872

NCT01336465
(ClinicalTrials.gov)

September 2011

14/4/2011

Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: placebo;Drug: rhuMAb Beta7

Genentech, Inc.

NULL

Completed

18 Years

75 Years

Both

124

Phase 2

United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom

873

EUCTR2010-022506-41-BE
(EUCTR)

23/08/2011

17/06/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2

United States;Austria;Italy;France;Hungary;Mexico;Canada;Belgium;Poland;Brazil;Australia;South Africa;Netherlands;Germany

874

EUCTR2011-000897-80-BE
(EUCTR)

16/08/2011

27/06/2011

A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease

PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

Product Name: rhuMAb Beta7
Product Code: PRO145223 (RO5490261)
INN or Proposed INN: n.a.
Other descriptive name: rhuMAb Beta7

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand

875

EUCTR2010-023588-16-HU
(EUCTR)

11/08/2011

27/05/2011

Iron deficiency anaemia in quiescent ulcerative colitis
MedDRA version: 14.1;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

876

EUCTR2010-023588-16-GB
(EUCTR)

02/08/2011

11/05/2011

Iron deficiency anaemia in quiescent ulcerative colitis
MedDRA version: 16.0;Level: PT;Classification code 10022972;Term: Iron deficiency anaemia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.0;Level: LLT;Classification code 10002062;Term: Anaemia iron deficiency;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Hungary;Austria;Germany;United Kingdom

877

NCT01340872
(ClinicalTrials.gov)

August 2011

19/4/2011

Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)

A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1)

Iron Deficiency Anaemia;Inflammatory Bowel Disease;Ulcerative Colitis

Drug: ST10-021;Drug: Placebo Comparator

Shield Therapeutics

NULL

Completed

18 Years

N/A

All

128

Phase 3

Austria;United Kingdom

878

EUCTR2010-023762-49-AT
(EUCTR)

22/07/2011

26/04/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands

879

EUCTR2010-022506-41-DE
(EUCTR)

18/07/2011

28/02/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Germany;Netherlands

880

NCT01320436
(ClinicalTrials.gov)

July 2011

21/3/2011

Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis

Randomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis Patients

Ulcerative Colitis

Dietary Supplement: Curcumin;Drug: 5-aminosalicylic acid

Sheba Medical Center

NULL

Completed

18 Years

70 Years

Both

Phase 3

Israel

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

881

EUCTR2010-023588-16-AT
(EUCTR)

22/06/2011

16/05/2011

Iron Therapeutics (Switzerland) AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Austria;Germany;United Kingdom

882

EUCTR2010-023762-49-BG
(EUCTR)

06/06/2011

31/05/2011

A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

France;United States;Hungary;Canada;Belgium;Spain;Poland;Romania;Austria;Bulgaria;Germany;Netherlands

883

EUCTR2010-022506-41-HU
(EUCTR)

31/05/2011

13/04/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative
MedDRA version: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Australia;South Africa;Netherlands;Germany

884

EUCTR2010-022506-41-IT
(EUCTR)

16/05/2011

28/12/2011

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with BMS-936557 in Subjects with Active Ulcerative Colitis (UC)

Colitis, Ulcerative
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody
Product Name: Human anti-IP10 monoclonal antibody
Product Code: BMS-936557
INN or Proposed INN: Human anti-IP10 monoclonal antibody

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Hungary;Mexico;Canada;Poland;Brazil;Austria;Australia;South Africa;Germany;Italy

885

EUCTR2010-023762-49-ES
(EUCTR)

16/05/2011

11/02/2011

ESTUDIO EN FASE 2A, ALEATORIZADO, DOBLE CIEGO, SIN ENMASCARAMIENTO PARA EL PROMOTOR, CONTROLADO CON PLACEBO, DE DOSIS MÚLTIPLES PARA EVALUAR LA FARMACODINÁMICA, LA FARMACOCINÉTICA Y LA SEGURIDAD DE ANRUKINZUMAB EN PACIENTES CON COLITIS ULCEROSA ACTIVAA PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS

Colitis ulcerosa
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Not Applicable
Product Code: PF-05230917
INN or Proposed INN: Not Applicable
Other descriptive name: Not applicable

Pfizer, S.L.U.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2A

Hungary;Belgium;Poland;Spain;Bulgaria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

886

EUCTR2010-022506-41-AT
(EUCTR)

05/05/2011

01/03/2011

Induction and Maintenance Study of BMS-936557 Patients with Moderateto Severe Ulcerative Colitis

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

386

Phase 2b

United States;Austria;Italy;France;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Australia;South Africa;Netherlands;Germany

887

NCT01772615
(ClinicalTrials.gov)

May 2011

17/1/2013

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle

Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle

Ulcerative Colitis

Drug: Ciprofloxacin;Dietary Supplement: E. coli Nissle

Hvidovre University Hospital

NULL

Completed

18 Years

N/A

Both

100

Phase 4

Denmark

888

NCT01479660
(ClinicalTrials.gov)

March 2011

22/11/2011

Role of Healthy Bacteria in Ulcerative Colitis

Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial

Ulcerative Colitis

Other: Control;Drug: Probiotic

Postgraduate Institute of Medical Education and Research

Ministry of Science and Technology, India

Recruiting

18 Years

65 Years

Both

100

Phase 4

India

889

NCT01294410
(ClinicalTrials.gov)

March 2011

10/2/2011

Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

Colitis, Ulcerative

Drug: Placebo;Drug: Anti-IP-10 Antibody

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

305

Phase 2

United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Mexico;Netherlands;Poland;South Africa

890

NCT01284062
(ClinicalTrials.gov)

March 2011

25/1/2011

Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients

A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Anrukinzumab;Other: placebo

Pfizer

NULL

Completed

18 Years

65 Years

All

Phase 2

United States;Austria;Bulgaria;Canada;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

891

EUCTR2010-019558-42-SK
(EUCTR)

23/02/2011

27/10/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Hungary;Czech Republic;Slovakia;Belgium

892

EUCTR2010-023494-19-SE
(EUCTR)

10/02/2011

27/12/2010

A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Lysine -D-Proline-Threonine
Product Code: K(D)PT

Dr. August Wolff GmbH & Co. KG Arzneimittel

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Sweden

893

EUCTR2010-019970-33-GB
(EUCTR)

01/02/2011

13/10/2010

A multi-centre, double-blind, placebo controlled, parallelgroup, proof of concept study to evaluate the efficacy,safety and tolerability of KRP203 in subjects withmoderately active refractory ulcerative colitis -

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: KRP203A
Product Code: KRP203A
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;United Kingdom;Belgium;Sweden

894

NCT01240915
(ClinicalTrials.gov)

February 2011

10/11/2010

A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis

A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis

Colitis, Ulcerative

Drug: placebo;Drug: MultiStem low dose;Drug: MultiStem high dose

Pfizer

Athersys, Inc

Completed

18 Years

N/A

All

105

Phase 2

United States;Belgium;Canada;Germany;Hungary;Italy;Slovakia;Sweden

895

NCT01290042
(ClinicalTrials.gov)

February 2011

27/1/2011

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.

Ulcerative Colitis;Crohn's Disease

Drug: AMG 181;Other: Placebo for AMG 181

Amgen

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States;Australia

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

896

EUCTR2010-019558-42-HU
(EUCTR)

20/01/2011

10/11/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Czech Republic;Belgium

897

EUCTR2010-019558-42-CZ
(EUCTR)

10/01/2011

25/10/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Czech Republic;Belgium

898

EUCTR2010-019558-42-BE
(EUCTR)

23/12/2010

13/10/2010

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Baminercept
Product Code: BG9924
INN or Proposed INN: N/A
Other descriptive name: Baminercept

Biogen Idec Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

100

Hungary;Czech Republic;Belgium

899

EUCTR2010-019970-33-DE
(EUCTR)

22/12/2010

15/10/2010

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: KRP203
Product Code: KRP203
Product Name: KRP203
Product Code: KRP203
Product Name: KRP203
Product Code: KRP203

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;United Kingdom;Germany;Belgium;Sweden

900

EUCTR2010-020448-37-BE
(EUCTR)

10/12/2010

22/12/2010

Product Name: PEG -liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE

Enceladus Pharmaceuticals

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

901

EUCTR2010-019970-33-BE
(EUCTR)

07/12/2010

20/09/2010

Ulcerative colitis
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Product Code: KRP203A
Product Code: KRP203A
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Germany;United Kingdom;Sweden

902

NCT01375179
(ClinicalTrials.gov)

December 2010

12/5/2011

Efficacy & Safety in Moderately Active Refractory Ulcerative Colitis Patients

A Multi-centre, Double-blind, Placebo Controlled, Parallel Group, Proof of Concept Study to Evaluate the Efficacy, Safety and Tolerability of KRP203 in Subjects With Moderately Active Refractory Ulcerative Colitis

Ulcerative Colitis

Drug: KRP203;Drug: Placebo matching KRP203

Novartis Pharmaceuticals

NULL

Terminated

18 Years

65 Years

All

Phase 2

Belgium;Germany;Hungary;Sweden;Switzerland;United Kingdom

903

EUCTR2010-019970-33-HU
(EUCTR)

11/11/2010

07/09/2010

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: n.a.
Product Code: KRP203A
Product Name: n.a
Product Code: KRP203A
Product Name: n.a
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;United Kingdom;Belgium;Sweden

904

EUCTR2010-019970-33-SE
(EUCTR)

29/10/2010

10/09/2010

Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: KRP203
Product Code: KRP203A
Product Name: KRP203
Product Code: KRP203A
Product Name: KRP203
Product Code: KRP203A

Novartis Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Belgium;Germany;United Kingdom;Sweden

905

NCT01111292
(ClinicalTrials.gov)

October 2010

24/4/2010

Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia

Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia

Colon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal Carcinoma

Drug: Inositol;Other: Placebo

National Cancer Institute (NCI)

NULL

Terminated

18 Years

N/A

All

Phase 1;Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

906

NCT01320332
(ClinicalTrials.gov)

August 2010

15/3/2011

A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis

A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis

Ulcerative Colitis

Drug: ASP3291;Drug: Placebo

Telsar Pharma Inc.

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States

907

NCT01216280
(ClinicalTrials.gov)

July 2010

2/9/2010

Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: placebo capsule;Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule;Drug: 2 x 10 mg Natura-alpha capsules

Natrogen Therapeutics International, Inc

NULL

Active, not recruiting

18 Years

70 Years

Both

Phase 2

United States

908

NCT01164904
(ClinicalTrials.gov)

July 2010

1/7/2010

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Amg 181

Amgen

NULL

Terminated

18 Years

55 Years

Both

Phase 1

United States;Australia;New Zealand

909

NCT01149707
(ClinicalTrials.gov)

June 1, 2010

22/6/2010

Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

Left-Sided Ulcerative Colitis;Proctosigmoiditis

Drug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo Enema

PurGenesis Technologies Inc.

NULL

Completed

18 Years

75 Years

All

Phase 2

Germany

910

EUCTR2006-003398-28-CZ
(EUCTR)

24/05/2010

10/02/2010

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT Subcutaneous

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in prefilled syringe
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

France;Hungary;Czech Republic;Belgium;Lithuania;Denmark;Austria;Bulgaria;Netherlands;Latvia;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

911

EUCTR2006-003399-37-CZ
(EUCTR)

24/05/2010

10/02/2010

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Maintenance

Ulcerative Colitis (UC)
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan;Sweden

912

EUCTR2009-017839-18-DE
(EUCTR)

14/05/2010

16/02/2010

A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS

Active mild-to-moderate distal ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)

PurGenesis Techonologies Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Germany

913

NCT00572585
(ClinicalTrials.gov)

April 2010

12/12/2007

Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

A Randomized, Double Blind, Placebo Controlled, Parallel Group Design Study to Explore the Efficacy, Safety and Tolerability of AEB071 in Patients With Active, Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: AEB071;Drug: Placebo

Novartis Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Denmark;Germany;Poland

914

EUCTR2008-003169-19-GB
(EUCTR)

04/03/2010

17/09/2009

A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Sigmoid Pharma Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Ireland;United Kingdom

915

NCT01033305
(ClinicalTrials.gov)

March 2010

15/12/2009

Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™)

A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative Colitis

Mild to Moderate Ulcerative Colitis

Drug: CyCol™;Drug: Placebo

Sigmoid Pharma

NULL

Completed

18 Years

N/A

Both

118

Phase 2

Ireland;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

916

NCT01040910
(ClinicalTrials.gov)

January 2010

29/12/2009

Cannabis for Inflammatory Bowel Disease

A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis

Drug: smoking of cannabis;Drug: smoking cigarettes with placebo

Meir Medical Center

NULL

Recruiting

20 Years

70 Years

Both

Phase 1;Phase 2

Israel

917

NCT01037322
(ClinicalTrials.gov)

January 2010

20/12/2009

Cannabidiol for Inflammatory Bowel Disease

Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease

Crohn's Disease;Ulcerative Colitis

Drug: cannabidiol;Drug: placebo in drops

Meir Medical Center

NULL

Completed

20 Years

80 Years

Both

Phase 1;Phase 2

Israel

918

EUCTR2008-002782-32-DK
(EUCTR)

18/12/2009

06/11/2008

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

919

NCT01039597
(ClinicalTrials.gov)

December 2009

23/12/2009

Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis

Mild to Moderate Ulcerative Colitis

Drug: ORE1001;Drug: Placebo

Ore Pharmaceuticals, Inc.

NULL

Recruiting

18 Years

70 Years

Both

Phase 1;Phase 2

Canada;India

920

NCT01011322
(ClinicalTrials.gov)

December 2009

10/11/2009

A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis

Ulcerative Colitis;Large Intestine;Diarrhea;Abdominal Pain

Drug: LT-02;Drug: placebo

Lipid Therapeutics GmbH

NULL

Active, not recruiting

18 Years

N/A

Both

156

Phase 2

Germany;Lithuania;Romania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

921

EUCTR2008-007952-90-LT
(EUCTR)

23/11/2009

15/09/2009

A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis.

Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for blood in stool” =2 at Baseline Visit.
MedDRA version: 12.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine
Product Name: LT-02 (modified-release PC pellets)
Product Code: LT-02
INN or Proposed INN: Modified-release phosphatidylcholine

Lipid Therapeutics GmbH

NULL

Not Recruiting

Female: yes
Male: yes

144

Phase 2b

Germany;Lithuania

922

EUCTR2008-007952-90-DE
(EUCTR)

17/11/2009

04/08/2009

Lipid Therapeutics GmbH

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2b

Germany;Lithuania

923

EUCTR2008-003169-19-IE
(EUCTR)

09/11/2009

05/06/2008

A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: CyCol
INN or Proposed INN: ciclosporin
Other descriptive name: cyclosporine (USAN)
Product Name: CyCol
INN or Proposed INN: ciclosporin
Other descriptive name: cyclosporine (USAN)

Sigmoid Pharma Ltd

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Ireland

924

NCT01059344
(ClinicalTrials.gov)

November 2009

28/1/2010

Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis

Ulcerative Colitis

Drug: Mesalamin

Tillotts Pharma AG

NULL

Completed

18 Years

N/A

All

281

Phase 3

Belarus;India;Turkey;Ukraine

925

EUCTR2009-011608-51-DE
(EUCTR)

09/10/2009

21/07/2009

A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis

Ulcerative colitis
MedDRA version: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders

Product Name: GSK1399686
Product Code: GSK1399686
Trade Name: ASACOL
Product Name: ASACOL
Product Code: ASACOL
INN or Proposed INN: mesalazine
Other descriptive name: Overencapsulated mesalazine tablets
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686
Product Name: GSK1399686
Product Code: GSK1399686

GlaxoSmithKline Research and Development Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

926

EUCTR2009-010921-38-NL
(EUCTR)

08/09/2009

02/03/2009

Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC

Ulcerative Colitis and the risk of developing colorectal cancer.
MedDRA version: 13.1;Level: PT;Classification code 10021972;Term: Inflammatory bowel disease;System Organ Class: 10017947 - Gastrointestinal disorders

Trade Name: Salofalk
INN or Proposed INN: mesalazine
Trade Name: Ursofalk
INN or Proposed INN: ursodeoxycholic acid

UMC Utrecht

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Netherlands

927

NCT01036022
(ClinicalTrials.gov)

September 1, 2009

17/12/2009

Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis

Colitis, Ulcerative

Drug: GSK1399686

GlaxoSmithKline

NULL

Completed

18 Years

65 Years

All

120

Phase 2

Belgium;Canada;Germany;Norway;Sweden

928

EUCTR2008-002782-32-DE
(EUCTR)

24/08/2009

23/04/2009

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

995

Phase 3

Portugal;Serbia;Taiwan;Estonia;Hong Kong;Greece;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Democratic People's Republic of;Turkey;Austria;Malta;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Iceland;New Zealand

929

EUCTR2009-011608-51-SE
(EUCTR)

17/08/2009

22/06/2009

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

GlaxoSmithKline Research and Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Sweden

930

EUCTR2008-002782-32-AT
(EUCTR)

13/08/2009

28/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Other descriptive name: LDP-02

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

931

EUCTR2009-011608-51-BE
(EUCTR)

03/08/2009

23/06/2009

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

GlaxoSmithKline Research and Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belgium;Germany;Sweden

932

EUCTR2008-002782-32-IT
(EUCTR)

22/07/2009

22/01/2009

Patients with Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Vedolizumab
Product Code: MLN0002
INN or Proposed INN: Vedolizumab

MILLENNIUM PHARMACEUTICALS, INC.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

933

EUCTR2008-002782-32-GB
(EUCTR)

20/07/2009

27/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

934

EUCTR2008-002782-32-CZ
(EUCTR)

13/07/2009

31/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

935

NCT01149694
(ClinicalTrials.gov)

June 2009

22/6/2010

A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers

A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers

Ulcerative Colitis

Drug: PUR 0110 Rectal Enema or Placebo Enema

PurGenesis Technologies Inc.

NULL

Completed

18 Years

55 Years

Male

Phase 1

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

936

EUCTR2008-003913-28-IT
(EUCTR)

25/05/2009

16/04/2009

Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND

Mild to moderate ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Budesonide -MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

150

Italy

937

EUCTR2007-004867-22-SK
(EUCTR)

25/05/2009

28/05/2009

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Avonex
Product Name: Avonex

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Czech Republic;Hungary;Slovakia

938

EUCTR2008-004564-40-GB
(EUCTR)

20/05/2009

14/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

939

EUCTR2006-003607-40-FI
(EUCTR)

23/04/2009

26/02/2009

METEOR: A CONTROLLED, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METH-OTREXATE VS PLACEBO IN THE REMISSION OF STEROID-DEPENDENT ULCERATIVE COLITIS - METEOR

Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Trexan inj 25 mg/ml
INN or Proposed INN: Methotrexate

GETAID, Jean Minjoz Hospital

NULL

Not Recruiting

Female: yes
Male: yes

110

Finland;Belgium;Austria;Netherlands

940

EUCTR2008-002782-32-HU
(EUCTR)

14/04/2009

27/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

941

EUCTR2008-002782-32-GR
(EUCTR)

07/04/2009

05/11/2009

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

942

EUCTR2008-004610-27-SK
(EUCTR)

06/04/2009

09/02/2009

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Dersalazine sodium
Product Code: UR-12746-S
INN or Proposed INN: dersalazine sodium
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: Mesalazine
Trade Name: Lixacol
Product Name: Lixacol
INN or Proposed INN: mesalazine

Palau Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Slovakia;Spain;Belgium

943

EUCTR2008-004564-40-NL
(EUCTR)

24/03/2009

11/11/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

944

EUCTR2008-002782-32-FR
(EUCTR)

13/03/2009

14/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

826

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece

945

EUCTR2008-002782-32-PT
(EUCTR)

09/03/2009

06/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

946

EUCTR2008-002782-32-ES
(EUCTR)

02/03/2009

23/10/2008

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative ColitisEstudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave

Moderate to Severe Ulcerative ColitisColitis ulcerosa moderada o grave
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

947

EUCTR2008-004610-27-HU
(EUCTR)

26/02/2009

15/12/2008

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Palau Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain

948

EUCTR2008-002782-32-NL
(EUCTR)

18/02/2009

05/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Netherlands;Latvia;Iceland

949

EUCTR2008-002782-32-BE
(EUCTR)

08/02/2009

14/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

950

EUCTR2008-004564-40-CZ
(EUCTR)

05/02/2009

23/01/2009

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Slovakia;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

951

JPRN-JapicCTI-090718

01/2/2009

A Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis.

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis.

Ulcerative colitis

Intervention name : adalimumab
INN of the intervention : adalimumab
Dosage And administration of the intervention : 160/80 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo eow starting at Week 0 to Week 50

AbbVie GK

Eisai Co., Ltd.

BOTH

255

NULL

952

NCT00853099
(ClinicalTrials.gov)

February 2009

27/2/2009

A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis.

Ulcerative Colitis

Biological: adalimumab;Drug: placebo

AbbVie (prior sponsor, Abbott)

Eisai Co., Ltd.

Completed

15 Years

N/A

All

274

Phase 3

Japan

953

EUCTR2008-002783-33-AT
(EUCTR)

29/01/2009

28/10/2008

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Moderate to Severe Crohn's Disease
MedDRA version: 14.0;Level: LLT;Classification code 10013099;Term: Disease Crohns;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Portugal;Serbia;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden

954

EUCTR2008-002782-32-MT
(EUCTR)

28/01/2009

02/02/2009

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;United Kingdom;Czech Republic;Iceland;Malta;Denmark;Belgium;Estonia;Spain;Greece

955

EUCTR2008-002783-33-MT
(EUCTR)

28/01/2009

25/11/2008

Moderate to Severe Crohn's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013099;Term: Disease Crohns

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB
Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

1060

Phase 3

Hungary;Portugal;Germany;Netherlands;Bulgaria;France;Ireland;Italy;Latvia;Austria;Sweden;United Kingdom;Slovakia;Czech Republic;Iceland;Belgium;Malta;Denmark;Estonia;Spain;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

956

EUCTR2008-004564-40-FR
(EUCTR)

26/01/2009

16/03/2009

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

957

EUCTR2008-004564-40-IT
(EUCTR)

23/01/2009

29/09/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC

Product Name: CP -690,550
Product Name: CP -690,550
Product Name: CP -690,550

PFIZER

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

958

EUCTR2008-004564-40-SE
(EUCTR)

16/01/2009

01/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

959

EUCTR2008-004564-40-BE
(EUCTR)

13/01/2009

14/11/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

960

EUCTR2008-002782-32-IS
(EUCTR)

09/01/2009

06/11/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Iceland;Latvia;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

961

EUCTR2008-002782-32-EE
(EUCTR)

09/01/2009

24/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

962

EUCTR2008-002782-32-IE
(EUCTR)

09/01/2009

28/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

963

EUCTR2008-002782-32-BG
(EUCTR)

08/01/2009

12/01/2009

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

964

NCT00790478
(ClinicalTrials.gov)

January 2009

12/11/2008

Melatonin & Ulcerative Colitis

Melatonin and Ulcerative Colitis: A Pilot Clinical Trial

Ulcerative Colitis

Dietary Supplement: Melatonin;Other: Placebo

Emory University

NULL

Recruiting

18 Years

69 Years

Both

Phase 2

United States

965

NCT00783718
(ClinicalTrials.gov)

January 2009

31/10/2008

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

Ulcerative Colitis

Drug: vedolizumab;Other: Placebo

Millennium Pharmaceuticals, Inc.

NULL

Completed

18 Years

80 Years

All

895

Phase 3

United States;Canada;Puerto Rico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

966

EUCTR2008-002782-32-LV
(EUCTR)

19/12/2008

31/10/2008

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: VEDOLIZUMAB
Product Code: MLN0002
INN or Proposed INN: VEDOLIZUMAB

Millennium Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

826

Phase 3

Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland

967

EUCTR2008-004564-40-ES
(EUCTR)

15/12/2008

17/10/2008

ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO, PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP 690,550 EN SUJETOS CON COLITIS ULCEROSA DE MODERADA A GRAVEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP 690,550 es un fármaco en desarrollo para el tratamiento de los pacientes con colitis ulcerosa de moderada a grave.CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer S.A

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

968

EUCTR2006-003607-40-BE
(EUCTR)

09/12/2008

27/10/2008

A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN CORTICOSTEROID-DEPENDENT ULCERATIVE COLITIS - METEOR

Steroid-dependent ulcerative colitis

Trade Name: methotrexate bellon
Product Name: methotrexate bellon 25mg/ml
INN or Proposed INN: methotrexate bellon 25mg/ml

Besancon University Hospital

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

110

Finland;Belgium;Austria;Netherlands

969

JPRN-JapicCTI-090739

08/12/2008

10/04/2009

Ulcerative Colitis

Intervention name : golimumab
Dosage And administration of the intervention : SC

JANSSEN PHARMACEUTICAL K.K

NULL

BOTH

Phase 2;Phase 3

NULL

970

JPRN-JapicCTI-090740

08/12/2008

10/04/2009

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Intervention name : golimumab
Dosage And administration of the intervention : SC

JANSSEN PHARMACEUTICAL K.K

NULL

BOTH

Phase 3

NULL

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

971

EUCTR2008-004610-27-BE
(EUCTR)

02/12/2008

24/07/2008

A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Palau Pharma S.A.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain

972

NCT00787202
(ClinicalTrials.gov)

December 2008

6/11/2008

A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.

A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

Ulcerative Colitis

Drug: CP - 690 550;Other: placebo

Pfizer

NULL

Completed

18 Years

N/A

All

195

Phase 2

Belgium;Brazil;Chile;Czech Republic;Denmark;France;Hungary;Israel;Italy;Mexico;Netherlands;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Turkey

973

NCT00801723
(ClinicalTrials.gov)

December 2008

2/12/2008

(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.

Ulcerative Colitis

Drug: Budesonide MMX 6 mg Tablet;Drug: Placebo Tablet

Bausch Health Americas, Inc.

NULL

Completed

18 Years

75 Years

All

123

Phase 3

United States;Canada

974

NCT00808977
(ClinicalTrials.gov)

December 2008

15/12/2008

A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

A Double-blind, Randomised, Placebo and Mesalazine Controlled Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Active Colitis

Ulcerative Colitis

Drug: Dersalazine sodium;Drug: Mesalazine;Drug: Placebo

Palau Pharma S.A.

NULL

Completed

18 Years

65 Years

Both

Phase 2

Belgium;Hungary;Slovakia;Spain

975

EUCTR2006-003607-40-AT
(EUCTR)

26/11/2008

10/11/2008

A CONTROLLED, RANDOMISED,DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR

Steroid-dependent ulcerative colitis

Trade Name: methotrexate bellon
Product Name: methotrexate bellon 25mg/ml
INN or Proposed INN: methotrexate bellon 25mg/ml

Besancon University Hospitaö

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Finland;Netherlands;Austria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

976

EUCTR2008-004610-27-ES
(EUCTR)

25/11/2008

26/09/2008

Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis

Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Dersalazina sodica
INN or Proposed INN: dersalazine sodium
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE
Trade Name: LIXACOL
Product Name: LIXACOL
INN or Proposed INN: MESALAZINA
Other descriptive name: MESALAZINE

Palau Pharma S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Hungary;Belgium;Spain

977

EUCTR2008-004564-40-HU
(EUCTR)

20/11/2008

17/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden

978

EUCTR2006-003607-40-NL
(EUCTR)

13/11/2008

13/08/2008

A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR

Steroid-dependent ulcerative colitis

Trade Name: methotrexate bellon
Product Name: methotrexate bellon 25mg/ml
INN or Proposed INN: methotrexate bellon 25mg/ml

Besancon University Hospital

NULL

Not Recruiting

Female: yes
Male: yes

110

Finland;Netherlands;Austria

979

EUCTR2008-004564-40-SK
(EUCTR)

11/11/2008

24/10/2008

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Code: CP -690,550
Product Code: CP -690,550
Product Code: CP -690,550

Pfizer limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 2

France;Czech Republic;Hungary;Slovakia;Belgium;Spain;Netherlands;United Kingdom;Italy;Sweden

980

EUCTR2008-000967-40-NL
(EUCTR)

03/11/2008

30/05/2008

A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis

Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011

ActoGeniX NV.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2a

Netherlands;Belgium;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

981

EUCTR2006-003397-94-SE
(EUCTR)

23/10/2008

21/12/2007

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT - Intravenous

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden

982

EUCTR2007-002544-25-CZ
(EUCTR)

21/10/2008

07/01/2008

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis

Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: MDX-1100
Product Code: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 2

Hungary;Czech Republic;Latvia

983

EUCTR2006-004776-12-IT
(EUCTR)

15/10/2008

20/03/2009

Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02

Patients with mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Budesonide -MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide
Trade Name: ENTOCORT CR
INN or Proposed INN: Budesonide
Product Name: Budesonide MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

984

EUCTR2007-004867-22-CZ
(EUCTR)

07/10/2008

26/02/2008

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Avonex
Product Name: Avonex

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Czech Republic

985

NCT00751933
(ClinicalTrials.gov)

October 2008

11/9/2008

Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis

A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis.

Ulcerative Colitis

Biological: Vaccine Vivotif + Vaccine Dukoral + oats;Biological: Vaccine Vivotif + Vaccine Dukoral;Dietary Supplement: Oats;Other: Placebo

Haukeland University Hospital

Helse Vest

Terminated

18 Years

80 Years

All

Phase 2

Norway

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

986

EUCTR2006-003399-37-DK
(EUCTR)

25/09/2008

10/12/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

987

EUCTR2006-003398-28-DK
(EUCTR)

25/09/2008

04/12/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Belgium;Denmark;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

988

EUCTR2006-004776-12-SK
(EUCTR)

18/09/2008

16/07/2008

Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Budesonide -MMX ™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide -MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

Phase 3

France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden

989

NCT00694980
(ClinicalTrials.gov)

September 2008

7/6/2008

A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis

Ulcerative Colitis

Drug: placebo;Drug: rhuMAb Beta7

Genentech, Inc.

NULL

Completed

18 Years

70 Years

Both

Phase 1

United States;Belgium;Canada;Germany;Netherlands;United Kingdom

990

EUCTR2008-000967-40-SE
(EUCTR)

29/08/2008

04/06/2008

Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

ActoGeniX NV.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Netherlands;Belgium;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

991

EUCTR2006-003399-37-SE
(EUCTR)

26/08/2008

21/12/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

992

EUCTR2006-003398-28-SE
(EUCTR)

26/08/2008

21/12/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Lithuania;Sweden

993

EUCTR2006-004776-12-EE
(EUCTR)

04/08/2008

11/06/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden

994

NCT00720538
(ClinicalTrials.gov)

August 2008

18/7/2008

Thalidomide in Pediatric Inflammatory Bowel Diseases.

Randomized Controlled Double-blind Vs. Placebo Multicentre Study on the Safety and Effectiveness of Thalidomide in the Treatment of Refractory Crohn's Disease and Ulcerative Colitis.

Inflammatory Bowel Diseases;Crohn's Disease;Ulcerative Colitis

Drug: Thalidomide;Drug: placebo

IRCCS Burlo Garofolo

Ospedale Meyer;Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.;Vittore Buzzi Children's Hospital;University of Pisa;Pediatric Gastroenterology Unit, University of Messina.;Università degli Studi di Brescia;University of Trieste

Completed

2 Years

18 Years

Both

Phase 3

Italy

995

EUCTR2007-005166-12-DE
(EUCTR)

29/07/2008

15/01/2008

A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine

active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis

Product Name: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)
Product Name: HMPL-004
Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract)

Hutchison MediPharma Enterprises Limited

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

996

EUCTR2006-004776-12-GB
(EUCTR)

23/07/2008

25/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

Phase 3

France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden

997

EUCTR2006-004776-12-FR
(EUCTR)

07/07/2008

09/05/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

998

EUCTR2006-004776-12-BE
(EUCTR)

01/07/2008

18/06/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

999

NCT00578799
(ClinicalTrials.gov)

July 2008

18/12/2007

Effects of Probiotics in Patients With Ulcerative Colitis

Effects of Probiotics in Patients With Ulcerative Colitis.

Ulcerative Colitis

Dietary Supplement: Kyo-Dophilus;Dietary Supplement: placebo

University of California, Irvine

Wakunaga Pharmaceutical Co., Ltd.

Terminated

18 Years

65 Years

Both

Phase 1

United States

1000

NCT00729872
(ClinicalTrials.gov)

July 2008

4/8/2008

A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis

A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects With Moderately Active Ulcerative Colitis

Moderately Active Ulcerative Colitis

Biological: AG011;Other: Placebo

ActoGeniX N.V.

NULL

Completed

18 Years

N/A

Both

Phase 1;Phase 2

Belgium;Canada;Netherlands;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1001

EUCTR2005-003471-20-LT
(EUCTR)

26/06/2008

12/02/2008

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine ST 261 Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

Ulcerative Colitis
MedDRA version: 9.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Propionyl-L-carnitine
Product Code: ST261
INN or Proposed INN: Propionyl-L-Carnitine

SIGMA-TAU

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Italy;Lithuania

1002

EUCTR2007-004867-22-HU
(EUCTR)

18/06/2008

21/02/2008

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AVONEX® in Subjects with Moderate to Severe Ulcerative Colitis.

Moderate to Severe Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Avonex
Product Name: Avonex

Biogen Idec Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;Czech Republic

1003

EUCTR2006-004776-12-LT
(EUCTR)

17/06/2008

22/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Budesonide -MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide -MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania

1004

EUCTR2008-000967-40-BE
(EUCTR)

13/06/2008

05/08/2008

Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

ActoGeniX N.V

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

Netherlands;Belgium;Sweden

1005

EUCTR2006-003398-28-BG
(EUCTR)

10/06/2008

30/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1006

EUCTR2006-004776-12-SE
(EUCTR)

02/06/2008

10/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

1007

NCT00679380
(ClinicalTrials.gov)

June 2008

14/5/2008

(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC

Ulcerative Colitis

Procedure: Blood sampling, endoscopy;Drug: Budesonide MMX® 6 mg;Drug: Budesonide MMX® 9 mg;Drug: Entocort EC® 3 mg;Drug: Placebo

Bausch Health Americas, Inc.

Cosmo Technologies Ltd

Completed

18 Years

75 Years

All

514

Phase 3

Australia;Belgium;Estonia;France;Israel;Italy;Latvia;Lithuania;Poland;Romania;Russian Federation;Slovakia;Sweden;Ukraine;United Kingdom

1008

NCT00679432
(ClinicalTrials.gov)

June 2008

14/5/2008

(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.

Ulcerative Colitis

Procedure: Blood sampling, endoscopy;Drug: budesonide -MMX® 6 mg;Drug: budesonide -MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg

Bausch Health Americas, Inc.

NULL

Completed

18 Years

75 Years

All

510

Phase 3

United States;Canada;India;Mexico

1009

EUCTR2006-003399-37-BG
(EUCTR)

30/05/2008

30/04/2008

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

United States;Serbia;Slovakia;Ukraine;Israel;Russian Federation;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;New Zealand;Sweden

1010

EUCTR2006-003397-94-BG
(EUCTR)

30/05/2008

30/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;France;Bulgaria;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1011

EUCTR2007-002544-25-LV
(EUCTR)

29/05/2008

18/02/2008

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis

Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: MDX-1100
Product Code: MDX-1100

Bristol-Myers Squibb Company

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 2

Hungary;Czech Republic;Latvia

1012

EUCTR2006-004776-12-LV
(EUCTR)

29/05/2008

29/04/2008

Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

COSMO Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

492

United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden

1013

EUCTR2006-002781-20-SE
(EUCTR)

23/05/2008

04/03/2008

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1014

EUCTR2007-002544-25-HU
(EUCTR)

23/05/2008

07/01/2008

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis

Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: MDX-1100
Product Code: MDX-1100

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

106

Phase 2

Hungary;Czech Republic;Latvia

1015

EUCTR2007-004732-23-PL
(EUCTR)

05/05/2008

12/05/2008

A MULTICENTER, RANDOMIZED, BLINDED, PLACEBO CONTROLLED, PARALLEL DESIGN, THREE-ARM, BIOEQUIVALENCE STUDY WITH CLINICAL ENDPOINTS COMPARING MESALAMINE DELAYED RELEASE TABLETS 400mg TO THE REFERENCE LISTED DRUG ASACOL® DELAYED RELEASE TABLETS 400mg IN PATIENTS WITH MILD TO MODERATELY ACTIVE ULCERATIVE COLITIS.)

Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative

Product Name: Mesalamine
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE

EMET Pharmaceuticals, LLC

NULL

Not Recruiting

Female: yes
Male: yes

435

Estonia;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1016

NCT00676832
(ClinicalTrials.gov)

May 2008

9/5/2008

Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis

Colitis, Ulcerative

Drug: Placebo;Drug: COLAL-PRED

Prometheus Laboratories

NULL

Completed

18 Years

75 Years

Both

190

Phase 2

United States

1017

NCT00616434
(ClinicalTrials.gov)

May 2008

5/2/2008

A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis

Active Ulcerative Colitis

Drug: BG9418 (Interferon beta-1a);Drug: Placebo

Biogen

NULL

Completed

18 Years

65 Years

All

123

Phase 2

United States;Canada;Czech Republic;Hungary;Poland;Russian Federation;Slovakia

1018

NCT00656890
(ClinicalTrials.gov)

April 2008

4/4/2008

A Study of MDX-1100 in Subjects With Active Ulcerative Colitis

A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Biological: sterile saline for injection;Biological: MDX-1100

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

Both

110

Phase 2

United States;Canada;Czech Republic;Hungary;Latvia;Romania;Russian Federation;Ukraine

1019

EUCTR2006-002782-40-AT
(EUCTR)

16/03/2008

20/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1020

NCT00718094
(ClinicalTrials.gov)

March 2008

16/7/2008

Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis

A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis

Mild to Moderately Active Ulcerative Colitis

Drug: Polyphenon E®;Drug: Placebo Oral Tablet

University of Louisville

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Completed

18 Years

85 Years

All

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1021

EUCTR2006-003604-19-PL
(EUCTR)

27/02/2008

07/11/2007

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1022

EUCTR2006-002781-20-AT
(EUCTR)

27/02/2008

23/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

475

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1023

EUCTR2007-004732-23-LV
(EUCTR)

27/02/2008

28/02/2008

A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis

Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE

EMET Pharmaceuticals LLC

NULL

Not Recruiting

Female: yes
Male: yes

435

Estonia;Latvia;Poland

1024

EUCTR2006-002782-40-DE
(EUCTR)

20/02/2008

18/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Czech Republic;Germany;Denmark;France;Austria

1025

NCT00659802
(ClinicalTrials.gov)

February 7, 2008

8/4/2008

Phase II Study of HMPL-004 in Patients With Ulcerative Colitis

A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine

Ulcerative Colitis

Drug: HMPL-004 low dose;Drug: Placebo;Drug: HMPL-004 high dose

Hutchison Medipharma Limited

NULL

Completed

18 Years

N/A

All

224

Phase 2

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1026

NCT00628433
(ClinicalTrials.gov)

February 2008

25/2/2008

Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

A Phase I/II, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Activity of HE3286 When Administered Orally to Patients With Active, Mild-to-Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Placebo;Drug: HE3286

Harbor Therapeutics

NULL

Completed

18 Years

65 Years

Both

Phase 1;Phase 2

United States

1027

EUCTR2006-003397-94-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1028

EUCTR2006-003398-28-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1029

EUCTR2006-003399-37-LT
(EUCTR)

29/01/2008

30/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1030

EUCTR2006-003399-37-NL
(EUCTR)

17/01/2008

08/10/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1031

EUCTR2006-003398-28-NL
(EUCTR)

17/01/2008

08/10/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1032

EUCTR2006-003397-94-NL
(EUCTR)

17/01/2008

07/08/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1033

NCT01045018
(ClinicalTrials.gov)

January 2008

17/12/2009

A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis

BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis

Mild to Moderate Ulcerative Colitis

Drug: Placebo;Drug: Mesalamine

EMET Pharmaceuticals, LLC

Eagle Pharmaceuticals, Inc.

Completed

18 Years

N/A

Both

Phase 3

NULL

1034

EUCTR2006-003398-28-BE
(EUCTR)

10/12/2007

18/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1035

EUCTR2007-002542-38-DK
(EUCTR)

28/11/2007

08/11/2007

A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis

A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210

Product Name: Sotrastaurin
Product Code: AEB071
INN or Proposed INN: Sotrastaurin (INN) acetate
Product Name: Vitamin B2
INN or Proposed INN: Riboflavin

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Denmark;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1036

EUCTR2006-003399-37-DE
(EUCTR)

27/11/2007

03/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Serbia;United States;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1037

EUCTR2006-003399-37-BE
(EUCTR)

15/11/2007

18/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

1038

EUCTR2006-003397-94-AT
(EUCTR)

15/11/2007

16/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1039

EUCTR2006-003397-94-BE
(EUCTR)

15/11/2007

18/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1040

EUCTR2006-003398-28-DE
(EUCTR)

15/11/2007

03/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1041

EUCTR2006-003399-37-HU
(EUCTR)

30/10/2007

10/07/2007

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) in Patients with Moderately to Severely Active Ulcerative Colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

Serbia;Saudi Arabia;Slovakia;Finland;Ukraine;Lithuania;Austria;Israel;Russian Federation;India;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;Bulgaria;Netherlands;Latvia;Germany;New Zealand;Sweden

1042

EUCTR2006-003397-94-HU
(EUCTR)

30/10/2007

10/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

700

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1043

EUCTR2006-003398-28-HU
(EUCTR)

29/10/2007

10/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1044

EUCTR2007-002542-38-DE
(EUCTR)

29/10/2007

22/02/2008

A clinical study to explore the safe and effective use of the drugsotrastaurin in patients with ulcerative colitis

A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis.

Product Code: AEB071A
Trade Name: B2-ASmedic
Product Name: B2-ASmedic
INN or Proposed INN: RIBOFLAVIN

Novartis Pharma Services AG

NULL

Not Recruiting

Female: yes
Male: yes

Denmark;Germany

1045

EUCTR2007-004732-23-EE
(EUCTR)

22/10/2007

23/10/2007

Mild to moderately active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: Mesalamine Delayed Release Tablets 400mg
INN or Proposed INN: MESALAZINE
Trade Name: Asacol
Product Name: Asacol Delayed-Release Tablets
INN or Proposed INN: MESALAZINE

EMET Pharmaceuticals LLC

NULL

Not Recruiting

Female: yes
Male: yes

435

Estonia;Latvia;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1046

EUCTR2006-003398-28-SK
(EUCTR)

04/10/2007

23/12/2009

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden

1047

EUCTR2006-003399-37-SK
(EUCTR)

04/10/2007

23/12/2009

A Study of the Safety and Effectiveness of CNTO 148 (golimumab) inPatients with Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis (UC)
MedDRA version: 14.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen Biologics BV

NULL

Not Recruiting

Female: yes
Male: yes

1228

Phase 3

Slovakia;Lithuania;Austria;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Sweden

1048

EUCTR2006-003397-94-SK
(EUCTR)

04/10/2007

16/04/2008

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

France;Hungary;Slovakia;Belgium;Lithuania;Austria;Bulgaria;Latvia;Netherlands;Germany;Sweden

1049

EUCTR2006-003399-37-AT
(EUCTR)

27/09/2007

17/07/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

United States;Serbia;Slovakia;Ukraine;Russian Federation;Israel;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;Lithuania;Austria;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan;Sweden

1050

EUCTR2006-003397-94-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1051

EUCTR2006-003398-28-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1052

EUCTR2006-003399-37-FR
(EUCTR)

21/09/2007

23/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

1350

Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1053

EUCTR2006-002782-40-PT
(EUCTR)

07/09/2007

18/06/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Hungary;Portugal;Germany;Czech Republic;Denmark;France;Austria

1054

EUCTR2006-003398-28-AT
(EUCTR)

06/09/2007

17/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

1002

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1055

EUCTR2006-003397-94-DE
(EUCTR)

05/09/2007

03/07/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1056

EUCTR2006-003397-94-LV
(EUCTR)

03/09/2007

04/09/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Golimumab Liquid in Vial
Product Code: CNTO 148
INN or Proposed INN: Golimumab
Other descriptive name: Human Anti-TNF IgG1 Monoclonal Antibody; rTNV148B IgG; Human Anti-TNFalfa

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Germany;Netherlands;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1057

EUCTR2006-003398-28-LV
(EUCTR)

03/09/2007

04/09/2007

Ulcerative Colitis (UC)
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Centocor BV

NULL

Not Recruiting

Female: yes
Male: yes

676

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Netherlands;Denmark;Belgium;Bulgaria;France;Latvia;Austria;Sweden;Lithuania

1058

EUCTR2006-003399-37-LV
(EUCTR)

03/09/2007

04/09/2007

The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis

Janssen Biologics B.V.

NULL

Not Recruiting

Female: yes
Male: yes

1350

Phase 3

Germany;France;Bulgaria;Austria;Australia;South Africa;Sweden;Czech Republic;Canada;Serbia;Belgium;United States;Poland;Hungary;Netherlands;Latvia;Lithuania;Israel;India;Russian Federation;Slovakia;Ukraine;Denmark;Romania;Japan

1059

NCT00488631
(ClinicalTrials.gov)

September 2007

18/6/2007

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

1228

Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom

1060

NCT00498589
(ClinicalTrials.gov)

September 2007

9/7/2007

Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis

Ulcerative Colitis

Drug: methotrexate;Drug: placebo

Centre Hospitalier Universitaire de Besancon

NULL

Completed

18 Years

75 Years

Both

110

Phase 2

Austria;Belgium;France;Israel;Italy;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1061

EUCTR2006-003604-19-GB
(EUCTR)

16/08/2007

09/03/2007

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. + Protocol Amendment 06 - Site specific - U.K. (Version 1.0, Date: 26-Jun-2007).+ Protocol amendment 04 - Biopsy substudy - Site specific+ Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-2006).

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Ireland;Germany

1062

EUCTR2006-003604-19-CZ
(EUCTR)

15/08/2007

11/05/2007

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

United Kingdom;Germany;Czech Republic;Belgium;France;Ireland;Italy;Poland

1063

EUCTR2006-003604-19-DE
(EUCTR)

06/08/2007

15/12/2006

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1064

NCT00488774
(ClinicalTrials.gov)

August 2007

18/6/2007

An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Other: Placebo;Drug: Golimumab 1 mg per kg;Drug: Golimumab 2 mg per kg;Drug: Golimumab 4 mg per kg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Terminated

18 Years

N/A

All

291

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;France;Germany;Hungary;India;Israel;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Sweden;Ukraine;Former Serbia and Montenegro;United Kingdom

1065

NCT00487539
(ClinicalTrials.gov)

August 2007

14/6/2007

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis

Colitis, Ulcerative

Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg

Janssen Research & Development, LLC

Merck Sharp & Dohme Corp.

Completed

18 Years

N/A

All

1065

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1066

EUCTR2006-002781-20-BE
(EUCTR)

16/07/2007

10/01/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

475

Hungary;Czech Republic;Belgium;Austria;Germany;Italy;Sweden

1067

EUCTR2006-002782-40-DK
(EUCTR)

09/07/2007

07/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1068

NCT00537316
(ClinicalTrials.gov)

July 2007

28/9/2007

Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)

Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2)

Ulcerative Colitis

Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion

Merck Sharp & Dohme Corp.

NULL

Terminated

21 Years

N/A

All

242

Phase 3

Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom

1069

EUCTR2006-002781-20-DE
(EUCTR)

27/06/2007

04/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Czech Republic;Germany;Italy;Austria;Sweden

1070

EUCTR2006-003604-19-IE
(EUCTR)

26/06/2007

13/02/2007

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1071

EUCTR2006-002782-40-BE
(EUCTR)

19/06/2007

05/01/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany

1072

EUCTR2006-002782-40-FR
(EUCTR)

19/06/2007

06/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1073

EUCTR2006-002782-40-CZ
(EUCTR)

18/06/2007

10/04/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;Hungary;Germany;Czech Republic;Denmark;France;Austria

1074

EUCTR2006-004303-19-BE
(EUCTR)

08/06/2007

07/02/2007

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Czech Republic;United Kingdom;Belgium

1075

JPRN-UMIN000004401

2007/06/01

18/10/2010

A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis

Ulcerative colitis (Proctitis type)

Placebo arm:
A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks).

True arm:
A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study period

Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

Phase 2;Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1076

EUCTR2005-003707-37-BE
(EUCTR)

25/05/2007

18/12/2006

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Belgium;Austria

1077

EUCTR2006-003604-19-BE
(EUCTR)

10/05/2007

20/02/2007

A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate theClinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept inSubjects with Active Ulcerative Colitis (UC) who have had an Inadequate ClinicalResponse and/or Intolerance to Medical Therapy.Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1078

EUCTR2006-004303-19-CZ
(EUCTR)

09/05/2007

20/02/2007

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

181

United Kingdom;Czech Republic;Belgium

1079

EUCTR2005-003707-37-AT
(EUCTR)

09/05/2007

03/01/2007

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 3

Belgium;Austria

1080

EUCTR2006-002781-20-CZ
(EUCTR)

04/05/2007

16/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1081

EUCTR2006-004303-19-SK
(EUCTR)

04/05/2007

08/03/2007

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

181

Phase 2

Czech Republic;Slovakia;Belgium;United Kingdom

1082

NCT01177228
(ClinicalTrials.gov)

May 2007

5/8/2010

Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Ulcerative Colitis

Drug: Vedolizumab;Drug: Placebo

Millennium Pharmaceuticals, Inc.

NULL

Completed

18 Years

70 Years

All

Phase 2

NULL

1083

EUCTR2006-004303-19-GB
(EUCTR)

25/04/2007

06/12/2006

Steroid-refractory ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: Simulect
Product Name: Basiliximab
Other descriptive name: Basiliximab

Cerimon Pharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

135

Phase 2

Czech Republic;Slovakia;Belgium;United Kingdom

1084

EUCTR2006-002782-40-HU
(EUCTR)

18/04/2007

20/03/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Spain;Belgium;Austria;Denmark;Germany

1085

EUCTR2006-002781-20-IT
(EUCTR)

17/04/2007

07/03/2007

A multicenter,randomized, double-blind, placebo-controlled Study of Adalimumab for the Induction of clinical remission in subjects with moderately to severely active Ulcerative Colitis - ND

Moderately to severely active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Trade Name: HUMIRA

Abbott GmbH Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

250

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1086

EUCTR2006-002781-20-HU
(EUCTR)

26/03/2007

28/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Hungary;Germany;Czech Republic;Italy;Austria;Sweden

1087

EUCTR2006-002782-40-ES
(EUCTR)

23/03/2007

05/02/2007

A Multicenter, Randomized, Double-blind, Placebo controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis.Ensayo Multicéntrico, Aleatorizado, Doble ciego y controlado con Placebo del Anticuerpo Monoclonal Anti-TNF Adalimumab para la Induccción y el Mantenimiento de la Remisión Clínica en Sujetos con Colitis Ulcerosa Activa de Intensidad Moderada a Severa.

Moderately to severely active ulcerative colitis.Colitis Ulcerosa Activa de Intensidad Moderada a Severa
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

500

Portugal;France;Czech Republic;Hungary;Belgium;Spain;Austria;Denmark;Germany

1088

EUCTR2006-002781-20-SK
(EUCTR)

19/03/2007

01/02/2007

Moderately to severely active ulcerative colitis.
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Trade Name: Humira
INN or Proposed INN: Adalimumab

Abbott GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

575

Phase 3

Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany;Italy;Sweden

1089

EUCTR2006-003604-19-IT
(EUCTR)

09/03/2007

14/07/2008

ulcerative colitis, NOS
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Trade Name: Orencia
INN or Proposed INN: abatacept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

978

Phase 3

France;Czech Republic;Poland;Belgium;Ireland;Germany;United Kingdom;Italy

1090

EUCTR2006-004162-13-DE
(EUCTR)

27/02/2007

06/10/2006

Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients

Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.
MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease

Trade Name: Salofalk 4g/60ml Klysma
INN or Proposed INN: MESALAZINE

Charité Universitätsmedizin, Campus Charité Mitte

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1091

EUCTR2006-003604-19-FR
(EUCTR)

14/02/2007

29/12/2006

ULCERATIVE COLITIS,NOS
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

978

Phase 3

Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland

1092

EUCTR2005-003481-42-GR
(EUCTR)

30/01/2007

24/11/2006

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece

1093

EUCTR2005-005363-28-HU
(EUCTR)

25/01/2007

25/09/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria

1094

EUCTR2005-005363-28-AT
(EUCTR)

08/01/2007

10/01/2007

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria

1095

NCT00430898
(ClinicalTrials.gov)

January 2007

31/1/2007

Basiliximab in Moderate to Severe Ulcerative Colitis

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis

Ulcerative Colitis

Drug: Basiliximab

Cerimon Pharmaceuticals

NULL

Completed

18 Years

75 Years

Both

181

Phase 2

United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1096

NCT00502294
(ClinicalTrials.gov)

January 2007

13/7/2007

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous Steroid-Refractory Ulcerative Colitis

Drug: Visilizumab (HuM291; Nuvion®)

Facet Biotech

PDL BioPharma, Inc.

Withdrawn

18 Years

N/A

Both

150

Phase 3

NULL

1097

EUCTR2006-001782-42-HU
(EUCTR)

20/12/2006

16/08/2006

Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.

Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Product Name: CB-01-05-MMX
Product Code: CB-01-05-MMX
Other descriptive name: PARNAPARIN SODIUM

Cosmo Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;United Kingdom;Italy

1098

EUCTR2006-001846-15-SE
(EUCTR)

06/12/2006

20/10/2006

A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree

Active ulcerative colitis in steroid refractory or steroid dependent patients

Product Name: Kappaproct
Product Code: DIMS0150

InDex Pharmaceuticals AB

NULL

Not Recruiting

Female: yes
Male: yes

Sweden

1099

NCT00410410
(ClinicalTrials.gov)

December 2006

11/12/2006

A Study of Abatacept in Patients With Active Ulcerative Colitis

A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy

Ulcerative Colitis

Drug: abatacept (ABA);Drug: placebo;Drug: abatacept

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

591

Phase 3

United States;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;United Kingdom;Argentina;Spain

1100

EUCTR2006-001782-42-IT
(EUCTR)

03/11/2006

20/12/2006

Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - ND

Patients with mild to moderate active ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: CB-01-05-MMX

COSMO TECHNOLOGIES LTD

NULL

Not Recruiting

Female: yes
Male: yes

120

Hungary;United Kingdom;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1101

NCT00385736
(ClinicalTrials.gov)

November 2006

9/10/2006

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis

A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

18 Years

N/A

All

576

Phase 3

United States;Austria;Belgium;Canada;Czech Republic;Germany;Hungary;Italy;Netherlands;Poland;Puerto Rico;Slovakia;Sweden

1102

NCT00408629
(ClinicalTrials.gov)

November 2006

5/12/2006

Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

Ulcerative Colitis

Biological: adalimumab;Biological: placebo

Abbott

NULL

Completed

18 Years

N/A

All

518

Phase 3

United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;New Zealand;Norway;Poland;Portugal;Spain;Switzerland;Sweden

1103

EUCTR2006-001782-42-GB
(EUCTR)

17/10/2006

29/09/2006

Active left-sided, mild to moderate ulcerative colitis
MedDRA version: 8.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis

Cosmo Technologies Ltd

NULL

Not Recruiting

Female: yes
Male: yes

120

Phase 2

Hungary;Italy;United Kingdom

1104

NCT00951548
(ClinicalTrials.gov)

October 2006

2/8/2009

Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis

Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study

Ulcerative Colitis

Dietary Supplement: VSL#3;Dietary Supplement: Placebo

VSL Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

144

N/A

Italy

1105

NCT00643071
(ClinicalTrials.gov)

September 2006

20/3/2008

Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients

Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study

Ulcerative Colitis

Drug: Tacrolimus

Astellas Pharma Inc

NULL

Completed

16 Years

64 Years

Both

Phase 3

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1106

NCT00347048
(ClinicalTrials.gov)

September 2006

30/6/2006

Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients

Ulcerative Colitis

Drug: tacrolimus;Drug: Placebo

Astellas Pharma Inc

NULL

Completed

16 Years

64 Years

Both

Phase 3

Japan

1107

EUCTR2005-005363-28-BE
(EUCTR)

22/08/2006

27/04/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria

1108

NCT00279435
(ClinicalTrials.gov)

August 2006

17/1/2006

Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

Ulcerative Colitis

Drug: visilizumab

Facet Biotech

PDL BioPharma, Inc.

Terminated

18 Years

N/A

Both

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Ukraine

1109

EUCTR2005-005363-28-GB
(EUCTR)

11/07/2006

17/01/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 3

Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom

1110

EUCTR2005-003481-42-IT
(EUCTR)

08/06/2006

11/07/2007

A Randomized, Double-Blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intraveneous Steroid-Refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study - ND

subjects with IVSR-UC
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative

Product Name: visilizumab
INN or Proposed INN: visilizumab

PDL BioPharma, Inc;

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1111

EUCTR2005-003481-42-ES
(EUCTR)

26/05/2006

15/03/2006

A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab StudyEstudio aleatorizado, doble ciego y multicéntrico de Visilizumab frente a placebo en sujetos con colitis ulcerosa refractaria a esteroides intravenosos que hayan respondido previamente en un estudio con Visilizumab.

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)Colitis ulcerosa refractaria a esteróides intravenonsos
MedDRA version: 8.0;Level: LLT;Classification code 10045265

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Ireland;Spain;Italy;Greece

1112

EUCTR2005-005363-28-CZ
(EUCTR)

15/05/2006

18/04/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Germany;United Kingdom;Czech Republic;Belgium;Austria

1113

EUCTR2005-005363-28-DE
(EUCTR)

02/05/2006

02/06/2006

A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS

Trade Name: Kremezin
Product Name: AST-120
Product Code: AST-120
INN or Proposed INN: AST-120
Other descriptive name: Kremezin ®, Spherical Adsorptive Carbon

Ocera Therapeutics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Hungary;Czech Republic;United Kingdom;Germany;Belgium;Austria

1114

NCT01026857
(ClinicalTrials.gov)

May 2006

4/12/2009

Propionyl-L-Carnitine in Ulcerative Colitis

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomised, Multicenter Study to Investigate the Efficacy of Two Dosages of Propionyl-L-Carnitine Colon Release Tablets in Patients Affected by Ulcerative Colitis Under Oral Stable Treatment

Ulcerative Colitis

Drug: Propionyl-L-Carnitine;Drug: Placebo

sigma-tau i.f.r. S.p.A.

NULL

Completed

18 Years

75 Years

All

121

Phase 2

Italy;Lithuania;Poland;Russian Federation

1115

EUCTR2005-003481-42-SK
(EUCTR)

21/04/2006

25/11/2005

A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

Protein Design Labs, Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1116

EUCTR2005-003481-42-IE
(EUCTR)

04/04/2006

10/01/2006

A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany

1117

EUCTR2005-003481-42-HU
(EUCTR)

04/04/2006

28/11/2005

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Germany;Czech Republic;Slovakia;Spain;Ireland;Italy;Greece

1118

EUCTR2005-002063-87-HU
(EUCTR)

04/04/2006

02/05/2007

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Germany;Czech Republic;Belgium

1119

EUCTR2005-002063-87-DE
(EUCTR)

22/03/2006

29/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Czech Republic;Germany;Belgium

1120

EUCTR2005-003481-42-DE
(EUCTR)

22/03/2006

29/11/2005

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Hungary;Czech Republic;Slovakia;Germany;Spain;Ireland;Italy;Greece

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1121

EUCTR2005-002063-87-SK
(EUCTR)

16/03/2006

23/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Czech Republic;Slovakia;Belgium;Austria;Germany

1122

EUCTR2005-005414-20-IT
(EUCTR)

06/03/2006

31/01/2006

Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD

Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis
MedDRA version: 6.1;Level: PT;Classification code 10021972

Trade Name: Thalidomide Pharmion
INN or Proposed INN: Thalidomide

ISTITUTO PER L INFANZIA BURLO GAROFOLO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

124

Italy

1123

EUCTR2005-002063-87-CZ
(EUCTR)

16/02/2006

28/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Germany;Czech Republic;Belgium

1124

EUCTR2005-003481-42-CZ
(EUCTR)

16/02/2006

28/11/2005

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)
MedDRA version: 9.0;Level: LLT;Classification code 10045365

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

PDL BioPharma, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Hungary;Germany;Slovakia;Czech Republic;Spain;Ireland;Italy;Greece

1125

EUCTR2005-002063-87-BE
(EUCTR)

09/02/2006

24/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Germany;Czech Republic;Belgium

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1126

NCT00296556
(ClinicalTrials.gov)

February 2006

24/2/2006

Therapeutic Study of ONO-4819CD for Ulcerative Colitis

A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis.

Ulcerative Colitis

Drug: Rivenprost (drug)

Kyoto University, Graduate School of Medicine

National Institute of Biomedical Innovation

Terminated

20 Years

N/A

Both

Phase 2

Japan

1127

NCT00279422
(ClinicalTrials.gov)

February 2006

17/1/2006

A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Ulcerative Colitis

Drug: visilizumab

Facet Biotech

PDL BioPharma, Inc.

Terminated

18 Years

N/A

Both

127

Phase 2;Phase 3

United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;Norway;Slovakia;Ukraine

1128

EUCTR2005-003481-42-AT
(EUCTR)

04/01/2006

30/11/2005

A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: Visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

Protein Design Labs, Inc

NULL

Not Recruiting

Female: yes
Male: yes

Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany

1129

EUCTR2005-002063-87-AT
(EUCTR)

28/12/2005

23/11/2005

A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis

Intravenous steroid-refractory ulcerative colitis (IVSR-UC)

Product Name: Visilizumab (Nuvion)
Product Code: HuM291
INN or Proposed INN: visilizumab
Other descriptive name: anti-CD3 monoclonal antibody

Protein Design Labs, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

Hungary;Czech Republic;Belgium;Austria;Germany

1130

EUCTR2005-003471-20-IT
(EUCTR)

07/12/2005

17/01/2007

Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment

ULCERATIVE COLITIS
MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Propionyl-L-carnitine
Product Code: ST261
INN or Proposed INN: Levocarnitine

SIGMA-TAU

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Lithuania;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1131

JPRN-C000000288

2005/12/01

21/11/2005

Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase -

Patients with ulcerative colitis in active phase

Z-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.
Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets).
3 times a day (t.i.d.) after each meal for 8 weeks.

Zeria Pharmaceutical Co.,LTD.

NULL

Complete: follow-up complete

16years-old

64years-old

Male and Female

210

Phase 3

Japan

1132

JPRN-C000000289

2005/12/01

21/11/2005

Z-206 Phase III Clinical Trial- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase -

Patients with ulcerative colitis in remission phase.

Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.
Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets).
3 times a day (t.i.d.) after each meal for 48 weeks.

Zeria Pharmaceutical Co.,LTD.

NULL

Complete: follow-up complete

16years-old

64years-old

Male and Female

120

Phase 3

Japan

1133

EUCTR2005-003724-19-CZ
(EUCTR)

21/11/2005

05/10/2005

A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol

Active Ulcerative Colitis
MedDRA version: 8.0;Level: LLT;Classification code 10058816

Product Name: OPC-6535
Product Code: OPC-6535
INN or Proposed INN: Not applicable
Other descriptive name: OPC-6535

Otsuka Maryland Research Institute, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

375

Phase 3

Hungary;Czech Republic

1134

EUCTR2005-003724-19-HU
(EUCTR)

24/10/2005

07/09/2005

Active Ulcerative Colitis
MedDRA version: 8.0;Level: LLT;Classification code 10058816

Product Name: OPC-6535
Product Code: OPC-6535
INN or Proposed INN: Not applicable
Other descriptive name: OPC-6535

Otsuka Maryland Research Institute, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

375

Phase 3

Hungary

1135

NCT00928681
(ClinicalTrials.gov)

September 2005

22/6/2009

A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis

A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis.

Colitis, Ulcerative

Biological: Single dose-group A;Biological: Multiple dose- Group B;Biological: Multiple dose-Group B

Pfizer

NULL

Completed

18 Years

70 Years

Both

Phase 1

Belgium;Czech Republic;Denmark;Germany;Norway;Slovakia;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1136

EUCTR2004-001677-26-IT
(EUCTR)

06/06/2005

15/02/2006

Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study

Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis
MedDRA version: 6.1;Level: PT;Classification code 10009900

Product Name: Nolpitantium Besylate
Product Code: SR140333B

SANOFI-SYNTHELABO

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1137

NCT00232258
(ClinicalTrials.gov)

April 2005

3/10/2005

Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study

Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study

Ulcerative Colitis;Inflammatory Bowel Disease

Drug: Nolpitantium besylate

Sanofi

NULL

Completed

18 Years

N/A

Both

307

Phase 2

Argentina;Belgium;Brazil;Canada;Chile;Czech Republic;Estonia;Hungary;Italy;Russian Federation;Singapore;South Africa;Spain;Sweden;France;United States

1138

EUCTR2004-001677-26-EE
(EUCTR)

23/03/2005

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1139

EUCTR2004-001677-26-SE
(EUCTR)

07/02/2005

23/12/2004

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1140

EUCTR2004-001677-26-HU
(EUCTR)

25/01/2005

03/11/2004

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1141

EUCTR2004-001677-26-ES
(EUCTR)

14/01/2005

01/06/2005

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

Sanofi-Synthelabo Recherche

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1142

NCT00744016
(ClinicalTrials.gov)

December 2004

27/8/2008

Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Granulated mesalamine;Drug: Placebo

Bausch Health Americas, Inc.

NULL

Completed

18 Years

N/A

All

305

Phase 3

United States

1143

NCT00457171
(ClinicalTrials.gov)

December 2004

4/4/2007

GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis

A Double-Blind, Placebo-Controlled Phase I/II Study in Patients With Mild to Moderate Ulcerative Colitis Treated With GI-270384X, an Oral ICAM-1 and E-Selectin Inhibitor

Ulcerative Colitis

Drug: GI-270384

GlaxoSmithKline

NULL

Terminated

18 Years

55 Years

Both

Phase 1

Netherlands

1144

NCT00767728
(ClinicalTrials.gov)

December 2004

17/9/2008

Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: Granulated mesalamine;Drug: Placebo

Bausch Health Americas, Inc.

NULL

Completed

18 Years

N/A

All

256

Phase 3

United States

1145

NCT00207688
(ClinicalTrials.gov)

August 31, 2004

13/9/2005

A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients

A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Placebo

Janssen Research & Development, LLC

Janssen Biologics BV

Completed

N/A

All

505

New Zealand;Switzerland;United Kingdom;Argentina;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Israel;Netherlands;United States;Czech Republic

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1146

EUCTR2004-000733-12-CZ
(EUCTR)

14/07/2004

01/07/2004

A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.

Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.

Product Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)

Shire Pharmaceutical Development Inc

NULL

Not Recruiting

Female: yes
Male: yes

255

Phase 3

Czech Republic

1147

EUCTR2004-001677-26-CZ
(EUCTR)

09/03/2004

10/02/2005

Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE

Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis.
MedDRA version: 7.0;Level: LLT;Classification code 10045365

Product Name: Nolpitantium besylate
Product Code: SR140333B
INN or Proposed INN: Nolpitantium besylate

sanofi-aventis recherche & developpement

NULL

Not Recruiting

Female: yes
Male: yes

300

Hungary;Czech Republic;Estonia;Spain;Italy;Sweden

1148

NCT00548574
(ClinicalTrials.gov)

December 2003

23/10/2007

Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis

Ulcerative Colitis

Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: Mesalazine

Shire

NULL

Completed

18 Years

N/A

Both

343

Phase 3

Belgium

1149

JPRN-C000000078

2003/10/01

26/08/2005

Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study

Ulcerative Colitis

Patients in the treatment group receive an antibiotic combination consisting of amoxicillin 500mg tid, tetracycline 500mg tid, and metronidazole 250mg tid for two weeks.
patients in the control group recieve three kinds of placebo contained sugar.

Japan UC Antibiotics-therapy Study Group(JUCASG)

Nihon University,Iwate Medical University, Kyoto Central HospitalYamagata Central HospitalOita University, Tokyo Medical UniversityToyama Medical & Pharmaceutical University, Showa University

Complete: follow-up complete

15years-old

70years-old

Male and Female

210

Phase 2

Japan

1150

NCT00503243
(ClinicalTrials.gov)

September 2003

16/7/2007

Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis

Colitis, Ulcerative

Drug: Delayed and extended release mesalazine

Shire

NULL

Completed

18 Years

N/A

Both

280

Phase 3

United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1151

NCT00063830
(ClinicalTrials.gov)

June 2003

7/7/2003

ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.

ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis

Ulcerative Colitis

Drug: Alicaforsen

Isis Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

Phase 2

United States

1152

NCT00064454
(ClinicalTrials.gov)

May 2003

8/7/2003

FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis

FACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: OPC-6535 Tablets (drug)

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Completed

18 Years

80 Years

Both

375

Phase 3

United States

1153

NCT00064441
(ClinicalTrials.gov)

May 2003

8/7/2003

FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis

FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis

Ulcerative Colitis

Drug: OPC-6535 Tablets (drug)

Otsuka Pharmaceutical Development & Commercialization, Inc.

NULL

Completed

18 Years

80 Years

Both

375

Phase 3

United States

1154

NCT00073047
(ClinicalTrials.gov)

April 2003

14/11/2003

Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis

A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis

Ulcerative Colitis;Gastrointestinal Disease;Inflammatory Bowel Disease

Drug: Daclizumab

Facet Biotech

NULL

Completed

12 Years

N/A

Both

150

Phase 2

United States;Belgium;Canada

1155

NCT00374725
(ClinicalTrials.gov)

February 2003

7/9/2006

Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus.

Treatment of Ulcerative Colitis With a Combination of Lactobacillus Rhamnosus and Lactobacillus Acidophilus. A Randomised Placebo Controlled Trial

Ulcerative Colitis

Behavioral: Administration of probiotic (L. rhamnosus and L. acidophilus)

Odense University Hospital

University of Southern Denmark;Crohn's and Colitis Foundation

Completed

18 Years

N/A

Both

130

N/A

Denmark

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1156

NCT00065065
(ClinicalTrials.gov)

September 2002

16/7/2003

A Trial of Rosiglitazone for Ulcerative Colitis

A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis

Ulcerative Colitis;Inflammatory Bowel Disease

Drug: Rosiglitazone;Drug: Placebo

James Lewis

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);GlaxoSmithKline

Completed

18 Years

N/A

All

105

Phase 2

United States

1157

NCT00096655
(ClinicalTrials.gov)

May 2002

12/11/2004

A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

364

Phase 3

NULL

1158

NCT00036439
(ClinicalTrials.gov)

February 2002

10/5/2002

A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

Ulcerative Colitis

Drug: Infliximab

Centocor, Inc.

NULL

Completed

18 Years

N/A

Both

364

Phase 3

United States;Belgium

1159

NCT00510978
(ClinicalTrials.gov)

January 2002

2/8/2007

Probiotics in GastroIntestinal Disorders

One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis

Ulcerative Colitis;Crohn's Disease

Biological: Bifidobacterium infantis 35624;Biological: Lactobacillus salivarius UCC118;Biological: Placebo

University College Cork

European Commission

Active, not recruiting

N/A

75 Years

Both

360

Phase 2;Phase 3

Ireland

1160

NCT00303381
(ClinicalTrials.gov)

December 2001

14/3/2006

Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis

A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-finding Phase II Study of Subcutaneously Administered IFN-beta-1a in the Treatment of Patients With Moderately Active Ulcerative Colitis

Ulcerative Colitis

Drug: Interferon-beta -1a , 44 microgram;Drug: Placebo;Drug: Interferon-beta -1a , 66 microgram

EMD Serono

Merck Serono International SA

Completed

18 Years

N/A

Both

194

Phase 2

Germany;Israel;Netherlands;Singapore;Sweden;Switzerland;United Kingdom;Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1161

NCT00033943
(ClinicalTrials.gov)

January 2001

16/4/2002

Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis

Ulcerative Colitis

Drug: deligoparin

Incara Pharmaceuticals

NULL

Completed

18 Years

60 Years

Both

270

Phase 2;Phase 3

United States

1162

NCT00940576
(ClinicalTrials.gov)

July 2000

15/7/2009

Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases

Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study.

Ulcerative Colitis;Crohns Disease

Dietary Supplement: mare´s milk;Other: placebo drink

University of Jena

German Federal Ministry of Education and Research

Completed

10 Years

50 Years

All

N/A

Germany

1163

NCT00004810
(ClinicalTrials.gov)

June 1996

24/2/2000

Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis

Ulcerative Colitis

Drug: -aminosalicylic acid

National Center for Research Resources (NCRR)

University of Vermont

Completed

18 Years

80 Years

Both

Phase 2

NULL

1164

NCT00038922
(ClinicalTrials.gov)

September 1994

5/6/2002

Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis

Ulcerative Colitis;Inflammatory Bowel Disease

Drug: rhIL-11

Wyeth is now a wholly owned subsidiary of Pfizer

NULL

Terminated

18 Years

N/A

Both

Phase 1

United States

1165

EUCTR2014-004559-29-Outside-EU/EEA
(EUCTR)

12/11/2014

A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis

Trade Name: Humira 40 mg/0.8 ml solution for injection
Product Name: Adalimumab
Product Code: 331731-18-1
INN or Proposed INN: ADALIMUMAB

AbbVie Inc.

NULL

Female: yes
Male: yes

274

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1166

EUCTR2017-000573-37-BE
(EUCTR)

14/12/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody
Product Code: SHP647
INN or Proposed INN: Anti-MAdCAM antibody

Baxalta Innovations GmbH

NULL

Not Recruiting

Female: yes
Male: yes

772

Phase 3

1167

EUCTR2017-000573-37-PL
(EUCTR)

01/12/2017

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

772

Phase 3

United States;Serbia;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Lebanon;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan

1168

EUCTR2018-003986-33-PL
(EUCTR)

15/11/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany

1169

EUCTR2016-004677-40-GB
(EUCTR)

04/07/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis.

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1547

Phase 2;Phase 3

1170

EUCTR2018-003986-33-EE
(EUCTR)

19/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1171

JPRN-JapicCTI-111421

PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis.

Ulcerative Colitis

Intervention name : PS -SP
Dosage And administration of the intervention : PS -SP suppository 1g or placebo is administered rectally once a day.
Control intervention name : null

Kyorin Pharmaceutical Co.,LTD

NULL

BOTH

Phase 3

NULL

1172

EUCTR2018-003985-15-CZ
(EUCTR)

31/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

1173

EUCTR2018-003985-15-DE
(EUCTR)

01/07/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

1174

EUCTR2015-000319-41-PL
(EUCTR)

16/09/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

900

Phase 3

United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Slovenia;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand

1175

EUCTR2015-000319-41-BG
(EUCTR)

12/08/2015

The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC).

Celgene International II Sàrl (CIS II)

NULL

Not Recruiting

Female: yes
Male: yes

1050

Phase 3

Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Moldova, Republic of;Korea, Republic of;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1176

EUCTR2016-000641-31-DE
(EUCTR)

06/10/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1055

Phase 2;Phase 3

Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico;Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan

1177

JPRN-JapicCTI-184217

22/11/2018

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG)

Ulcerative Colitis

Intervention name : LY3074828
INN of the intervention : mirikizumab
Dosage And administration of the intervention : intravenous injection, Subcutaneous injection
Control intervention name : Placebo
INN of the control intervention : Placebo
Dosage And administration of the control intervention : intravenous injection, Subcutaneous injection

Eli Lilly Japan K.K.

NULL

pending

BOTH

Phase 3

NULL

1178

EUCTR2018-003985-15-BE
(EUCTR)

08/05/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

1179

JPRN-JapicCTI-184216

22/11/2018

Ulcerative Colitis

Intervention name : LY3074828
INN of the intervention : mirikizumab
Dosage And administration of the intervention : intravenous injection
Control intervention name : Placebo
INN of the control intervention : Placebo
Dosage And administration of the control intervention : intravenous injection

Eli Lilly Japan K.K.

NULL

recruiting

BOTH

Phase 3

NULL

1180

EUCTR2018-003985-15-PL
(EUCTR)

02/08/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 52

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals Inc.

NULL

Female: yes
Male: yes

372

Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Estonia;Slovakia;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Moldova, Republic of;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1181

EUCTR2017-000599-27-PL
(EUCTR)

04/12/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301)

Ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Female: yes
Male: yes

825

Phase 3

1182

EUCTR2016-004676-22-PL
(EUCTR)

15/06/2018

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-006
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

760

Phase 3

Lithuania;Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

1183

EUCTR2017-000572-28-IE
(EUCTR)

04/09/2017

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 302)

Product Code: SHP647
INN or Proposed INN: ontamalimab
Product Code: SHP647
INN or Proposed INN: ontamalimab

Shire Human Genetic Therapies, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

825

Phase 3

1184

EUCTR2016-004677-40-PL
(EUCTR)

20/06/2018

A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy

Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB
Product Name: Risankizumab
Product Code: ABBV-066
INN or Proposed INN: RISANKIZUMAB

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

720

Phase 2;Phase 3

United States;Serbia;Portugal;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Turkey;Lithuania;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden

1185

EUCTR2016-000641-31-NO
(EUCTR)

07/11/2016

Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis

AbbVie Deutschland GmbH & Co. KG

NULL

Female: yes
Male: yes

1055

Phase 2;Phase 3

Latvia;Korea, Republic of;Bosnia and Herzegovina;Czech Republic;Mexico;European Union;Canada;Brazil;Croatia;Sweden;Serbia;United States;Saudi Arabia;Estonia;Spain;Ireland;Russian Federation;Israel;Colombia;Switzerland;Malaysia;Australia;South Africa;Netherlands;China;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Argentina;Poland;Belgium;Singapore;Kazakhstan;Norway;Germany;New Zealand;Japan;Belarus;Portugal;Taiwan;Slovakia;Greece;Ukraine;Chile;France;Puerto Rico

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

1186

EUCTR2013-003032-77-FR
(EUCTR)

19/06/2015

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis.

Ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Abbvie Deutschland GmbH & Co. KG

NULL

Not Recruiting

Female: yes
Male: yes

225

Phase 3

United States;Slovakia;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;New Zealand

1187

EUCTR2018-003986-33-CZ
(EUCTR)

20/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856
MedDRA version: 20.1;Classification code 10045366;Term: Ulcerative colitis, unspecified;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3

1188

EUCTR2018-003986-33-DE
(EUCTR)

19/09/2019

A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with moderately to severely active Ulcerative Colitis

A Phase 3, Randomized, Double Blind, Placebo Controlled, 12 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects with Moderately to Severely Active Ulcerative Colitis - ELEVATE UC 12

Product Name: Etrasimod
Product Code: APD334
INN or Proposed INN: etrasimod L-arginine
Other descriptive name: AR401959 L-arginine

Arena Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

330

Phase 3