DDrare: Database of Drug Development for Rare Diseases

49. 全身性エリテマトーデス
［臨床試験数：827，薬物数：638（DrugBank：168），標的遺伝子数：108，標的パスウェイ数：191］

Searched query = "Systemic lupus erythematosus", "SLE"
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 = 0.15mg KPG-818 dose; 0.6mg KPG-818 dose; 1 mg/kg CNTO 136; 10 mg/kg CNTO 136; 2-deoxy-2 [F-18] fluoro-2-d-glucose; 2mg KPG-818 dose; 4 mg/kg CNTO 136; 81mg aspirin; A-623; ABATACEPT; ABBV-105; ABETIMUS SODIUM; ABR-215757; ABT-199; ABT-494; AC0058TA; ACM; ACT-334441; AGS-009; AIDSVAX® B/E; AKBM-3031; ALDESLEUCHINA; ALDESLEUKIN; ALITRETINOIN; ALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD; ALX-0061; ALX-0061 150 mg/mL; AMG 557; AMG 570; AMG 592; AMG 623; AMG 811; AMG592; AMG811; ANAKINRA; ANIFROLUMAB; ASF-1096 Cream 0.25%; ASF-1096 Cream 0.5%; ASF-1096 Cream 1.0%; ATACICEPT; Abatacept; Abetimus; Abetimus Sodium; Abetimus sodium; Abetimus sodium (LJP 394); Acetaminophen; Acetate; Acetylcysteine; Acido Micofenolico; Acido micofenolico; Acthar; Acthar Gel; Acthar high dose (80 U); Acthar low dose (40 U); Aldesleukin; Alfacalcidol; Alitretinoin; Allogeneic MSC (AlloMSC); Allogeneic Stem Cell Transplantation; Allogeneic bone marrow transplant; Alpha-tocopherol; Anakinra; Anifrolumab; Anifrolumab 1000 mg; Anifrolumab 300 mg; Anti BAFF (B cell activating factor); Anti LP40 antibody, subclass IgG4; Anti LP40 anticuerpo, subclase IgG4; Anti-CD19-CAR-T cells; Anti-CD20 B cell depletion with Truxima; Anti-CD28dAb; Anti-CD28dab; Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody; Anti-blood dendritic cell antigen 2; Anti-pandemic H1N1 influenza vaccine; Anti-thymocyte globulin; Aspirin; Aspirin and meloxicam; Atacicept; Atacicept 150 mg; Atacicept 75 mg; Atacicept 75 milligram (mg); Atorvastatin; Autologous EBV specific CTL infusion; Aviptadil; Azathioprine; BARICITINIB; BELIMUMAB; BENLYSTA; BENLYSTA? (belimumab); BENLYSTA™ (belimumab); BI 705564; BIIB059; BMS-188667; BMS-931699; BMS-986165; BMS-986165 Capsule; BMS-986165 Tablet; BMS-986195; BMS986195; BORTEZOMIB; BOS161721; BR-DIM; BT063; Baricitinib; Behavioral: heart health educational program; Behavioral: questionnaires; Belimumab; Belimumab 1 mg/kg; Belimumab 10 mg/kg; Belimumab 10 mg/kg plus standard therapy; Belimumab 100 mg SC; Belimumab 10mg/kg; Belimumab 200 mg SC; Belimumab 200 mg/mL; Belimumab 4 mg/kg; Belimumab Injection; Belimumab Injection [Benlysta]; Belimumab for IV; Belimumab for SC; Belimumab or benlysta; Belimumab plus Early Vaccination; Belimumab plus Late Vaccination; Benazepril; Benazepril Pill; Benlysta; Benlysta (Belimumab); Benlysta (belimumab); Benlysta 400 mg powder for concentrate for solution for infusion; Benlysta 400 mg powder for concentrate for solution for infusions; Benlysta®; Blisibimod; Blood sample; Bortezomib; Branebrutinib; Brentuximab; Brentuximab vedotin; Busulfan; CC; CC-220; CDP3194; CDP7657; CEP-33457; CFZ533; CICLOSPORIN; CICLOSPORINA; CNTO1275; CSM allogéniques issues de cordons ombilicaux ( MTI-PP); CTLA4-IgG4m (RG2077); CTLA4Ig; Calcitriol; Calcium; Campath; CellCept; Cellcept; Cenerimod; Cenerimod 0.5 mg; Cenerimod 1 mg; Cenerimod 2 mg; Cenerimod 4 mg; Cervarix; Cervarix suspensie voor injectie; Chloroquine; Cholecalciferol; Cholecalciferol and C. Xanthorrhiza; Ciclosporin; Ciclosporina; Clofarabine; Clopidogrel; Combination Product: Belimumab; Conjugated equine estrogens; Conjugated equine estrogens 0.625 mg/d + MPA 5 mg/d/10d; Continuation of azathioprine; Corn starch; Corticosteroids; Corticosteroids (prednisone or prednisolone); Creatine; Crestor; Csa; Cumulative corticosteroid exposure; Curcumin; Curcumin supplement; Cyclophosphamide; Cyclophosphamide-prednisone-azathioprine; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cymbalta; Cytarabine; D-glucose; DELTACORTENE*20CPR 5MG; DHA; DHEA; DZP; Dapagliflozin; Dapirolizumab pegol; Dapirolizumab pegol (DZP); Dehydroepiandrosterone; Dehydroepiandrosterone (DHEA); Device: Belimumab autoinjector; Device: Doppler ultrasound; Device: Flash glucose monitoring system; Device: bone densitometry; Device: fan beam CT scan; Device: flow-mediated dilation of the brachial artery; Dihydroartemisinin; Dihydroartemisinin tablet; Dimethylfumarat; Diphenhydramine; Dipyridamole; Docosahexaenoic acid; Drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom; ELSUBRUTINIB; EPA; EPA and DHA supplementation; EPRATUZUMAB; ERL080A; Edratide; Edratide Acetate; Eicosapentaenoic acid; Elsubrutinib; Enteric-Coated Mycophenolate Sodium; Epatuzumab; Epratuzumab; Epratuzumab 100 mg; Epratuzumab 1200 mg; Epratuzumab 400 mg; Epratuzumab 600 mg; Epratuzumab iv; Epratuzumab sc; Estradiol; Ethinyl estradiol; Ethylhydrogenfumarat, Calciumsalz; Ethylhydrogenfumarat, Magnesiumsalz; Ethylhydrogenfumarat, Zinksalz; Evobrutinib; Extended release dipyridamole 200mg/aspirin 25mg; Ezetimibe; Ezetimibe+Simvastatin Drug Combination; Faslodex; Filgrastim; Fish Oil; Fish oil; Fludarabine; Fludarabine phosphate; Fluzone; Focetria (Monovalent MF59-Adjuvanted vaccine); Folate; FolateScan (Technetium Tc 99mEC20); Folic acid; Forigerimod; Fostamatinib; Fostamatinib Disodium (R935788); Fumaderm®; Fumaderm® initial; G-CSF; GC+HCQ; GDC-0853; GDC-0853 RO7010939; GL701; GSK1550188; GSK1550188 1mg/kg or 10mg/kg; GSK1550188 IV; GSK1550188 SC; GSK2586184; GSK2586184 100 mg; GSK2586184 200 mg; GSK2586184 400 mg; GSK2586184 50 mg; GSK2586184 800mg single and repeat dose; GSK2586184 new formulation; GSK2586184 standard formulation; Gardasil; Genetic: Polymorphism Analysis; Glucose; Gold; Group A SLE prospective study; Growth colony stimulating factor (G-CSF); H.P. Acthar Gel; HCQ; HGS1006; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HLL2; HLL2 (Epratuzumab); HLL2 (trivial name or chemical description); HLL2,IMMU-103; HPV prophylactic vaccine Gardasil; HYDROXYCHLOROQUINE; Hematopoietic stem cell transplantation; High Dietary Sodium; High Dose Mesenchymal Stem Cells (MSCs); Hiomega-3 supplement of Naturalis® company -; HrIL-2 active; Human papillomavirus vaccination (Gardasil); Human umbilical cord derived MSC transplantation for SLE; Hydroxychloroquine; Hydroxychloroquine (Z0188); Hydroxychloroquine high; Hydroxychloroquine or Chloroquine; Hydroxychloroquine reduced; ICI 182,780 (Faslodex); ICP-022; IFN-K; IFN-Kinoid; IFN-Kinoid Drug Substance; IFN-a 2b Kinoid Drug Substance; IFN-a2b Kinoid; IFNa-Kinoid; IL-2; IL-6R nanobody; ILT-101; IMMU-103; IMMUNOGLOBULIN G; INFLUENZA VACCINE (SURFACE ANTIGEN, INACTIVATED); INTERLEUKIN 2; INTERLEUKIN-2; IPP - 201101; IPP-201101; IPP-201101, P140; Ianalumab; Ibandronate; Ibandronate+alfacalcidol+calcium; Immune ablation and hematopoietic stem cell support.; Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer; Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate); Individualized dose of rituximab; Infliximab; Influenz virus surface antigens; Influvac; Interleukin 2; Interleukin-2; Intravenous immunoglobulin; Iscalimab; Itolizumab; Itolizumab [Bmab 600]; JBT-101; JNJ-55920839; JNJ-56022473; KINERET; KPG-818; KZR-616; Kineret; L04AA26; LA294; LJP 394; LJP394; LY2127399; LY3009104; LY3361237; LY3471851; Laquinimod; Leflunomide; Lenalidomide; Levothyroxine; Lisinopril; Lisinopril Pills; Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 µg ethinyl estradiol); Low Dietary Sodium; Low Dose Mesenchymal Stem Cells (MSCs); Low-dose Aldesleukin (Proleukin®); Lulizumab Pegol; Lulizumab pegol; Lupuzor; LymphoStat-B; LymphoStat-B TM; LymphoStat-B®, monoclonal anti-BLyS, LSB, BENLYSTA®; M2951; M2951 (Other Name: Evobrutinib); M5049; MEDI 545; MEDI-545; MEDI-545 600; MEDI-546; MEDI-570 0.03 MG; MEDI-570 0.1 MG; MEDI-570 0.3 MG; MEDI-570 1 MG; MICOFENOLICO ACIDO; MMF; MONITOR; MPA; MRA 003 US; MSC treatment; MSC2364447C; MT-1303 High dose; MT-1303 Low dose; MTX; MYCOPHENOLIC ACID; MYFORTIC*50CPR RIV 360MG; MabThera; MabThera (Rituximab); Medi-546; Medroxyprogesterone; Melatonin; Meloxicam; Memantine; Mesenchymal Stromal Cells; Mesenchymal stem cells; Mesna; Metformin; Methotrexate; Methotrexate and folic acid; Methyl prednisolone; Methylprednisolone; Methylprednisolone sodium succinate; Micofenolico acido; Milatuzumab; Milnacipran; Mizoribine; Modafinil; Moxifloxacin; Multivitamin; Mycophenolate; Mycophenolate Mofetil; Mycophenolate mofetil; Mycophenolate mofetil (MMF); Mycophenolate motetil; Mycophenolic acid; Myfortic; N-(5-{4-[(3,3-dimethyl-1-azetidinyl)carbonyl]phenyl}[1,2,4]triazolo[1,5-a]pyridin-2-yl)cyclopropanecarboxamide; N-acetylcysteine; NNC 0151-0000-0000; NNC0114-0006; NOX-E36; Nelfinavir; Nicotinamide; Nivolumab; Norethindrone; Normal Saline; Null; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; Ocrelizumab; Olive; Olive Oil; Olive oil; Olumiant; Omacor; Omega-3; Oral Prednisone 5mg; Oral prednisolone; Orencia; Ortho-Novum 777; Ortho-novum; Other: Blood drawing only Group C; Other: Coaching Sessions; Other: Concomitant Medication; Other: Drug free; Other: Fitbit Activity Monitor; Other: GSK2586184 single dose taken with food; Other: GSK2586184 single dose taken without food; Other: Group B SLE one blood donation; Other: ISA 51 VG; Other: Pharmacokinetic analysis; Other: SLE treatment; Other: Smartphone Application; Other: Standard of Care; Other: Standard therapy; Other: Standard treatment according to the Clinical protocols; Other: Ultrasonography assessment; Other: corn starch; Other: immunologic technique; Other: laboratory biomarker analysis; Oxygen; Ozone; P 140; PAH; PF-04236921; PF-06700841; PF-06700841 15 mg; PF-06700841 25mg; PF-06700841 30 mg; PF-06700841 45 mg; PF-06700841 5mg; PF-06700841-15; PF-06835375; PREDNISONA; PREDNISONE; Paquinimod; Paquinimod (ABR-215757); Phosphate; Phosphate-buffered saline; Pioglitazone; Pitavastatin; Placebo; Plaquenil; Pneumovax; Pooled mesenchymal stem cell; Prasterone; Prasterone (GL701); Pravastatin; Prednisolone; Prednisolone/prednisone; Prednisona; Prednisone; Prednisone acetate; Prednisone discontinuation; Premarin and Provera; Prevenar® and Pneumo23®; Procedure: Autologous CD34+HPC transplantation (HSCT); Procedure: Autologous Peripheral Blood Stem Cell Transplantation; Procedure: CD34+ Peripheral Blood Stem Cell Reinfusion; Procedure: Computed Tomography; Procedure: Leukapheresis; Procedure: MRI, Venipuncture; Procedure: Non-myeloablative high dose immunosuppressive therapy conditioning (HDIT); Procedure: Plasmapheresis; Procedure: Positron Emission Tomography; Procedure: Reduced Intensity Allogeneic Transplant; Procedure: autologous hematopoietic stem cell transplantation; Proleukin; Quinipril; R-salbutamol; R-salbutamol sulphate; R932333; RANKL/OPG ratio; RAYOS; RC18 160 mg plus standard therapy; RC18 240 mg plus standard therapy; RC18 80 mg plus standard therapy; RECOMBINANT FACTOR FC FUSION PROTEIN; RIQUENT; RITUXIMAB; RO 496-4913; RO7010939/F13; ROSUVASTATIN CALCIUM; RSLV-132; Rabbit; Rabbit anti-thymocyte globulin; Rabbit antithymocyte globulin; Radiation: Fluorine F 18 Clofarabine; Radiation: Total body irradiation; Ramipril; Rapamycin; Raptiva; Recombinant zoster vaccine; Remicade; RhuMAb 2H7; RhuMAb IFNalpha; Rigerimod; Riquent; Rituxan (rituximab); Rituximab; Rivaroxaban; Ro 106-1443; Rontalizumab; Rosuvastatin; Royal jelly; SAR113244; SBI-087; SC belimumab 200 mg; SM101; SM934; SOLU-MEDROL; SQ Fludarabine; STELARA®; Salbutamol; Sifalimumab; Sifalimumab 1,200 mg; Sifalimumab 200 mg; Sifalimumab 600 mg; Simvastatin; Sirolimus; Solu-Medrol; Solu-medrol; Soluble Fc receptor; Soluble Fc-gamma receptor IIb; Standard dose of rituximab; Standard of Care; Standard therapy; Standard therapy (Excluding Immunosuppressants); Standard therapy (Including Immunosuppressants); Stelara; Steroid Drug; Steroid Taper; Subcuvia; Sugar pill; Sulfamethoxazole; Sulfate; Switch to Myfortic; TAB08; TACI-Fc5; TAK-079; TRU-015; TV-4710; Tabalumab; Tabalumab Auto-Injector; Tabalumab Prefilled Syringe; Tacrolimus; Thalidomide; The generic name is warfarin and many producers will be involved; Tocopherol; Tocopherol acetate; Toctino; Toctino®; Tofacitinib; Tofacitinib citrate; Trade Name Xarelto; Trade name Xarelto; Trimethoprim; Trimethoprim-Sulfamethoxazole; Triptorelin; Triptorelin pamoate; Truxima; UPADACITINIB; USTEKINUMAB; Upadacitinib; Urine sample; Ustekinumab; Ustekinumab (approximately 6 mg/kg); Ustekinumab 90 mg; Ustekinumab 90 milligram (mg); Ustekinumab IV; Ustekinumab SC; VAY736; VIB7734; VIP; Vaccination; Vaccine; Velcade; Velcade®; Versus hydroxychloroquine; Vitamin D; Vitamin D 25(OH)D; Vitamin D3; Vitamin D3 400 IU; Vitamin D3 6000 IU; Vitamins: B6, B12, and folate; Vobarilizumab; Warfarin; Warfarin Sodium; Warfarin sodium; Xarelto; XmAb5871; Zishenqing; Zostavax; Zostavax vaccine

No.	TrialID	Date_ enrollment	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	NCT04647708 (ClinicalTrials.gov)	December 2, 2020	23/11/2020	Study of M5049 in Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE) Participants	A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus Participants Treated With Standard of Care	Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus	Drug: M5049;Drug: Placebo	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not yet recruiting	18 Years	65 Years	All	40	Phase 1	Bulgaria;Germany;Moldova, Republic of;Ukraine
2	NCT04643067 (ClinicalTrials.gov)	December 1, 2020	12/11/2020	A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients	A Phase 1b/2a Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of KPG-818 in Patients With Mild to Moderate Systemic Lupus Erythematosus	SLE; Drug	Drug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: Placebo	Kangpu Biopharmaceuticals, Ltd.	NULL	Not yet recruiting	18 Years	N/A	All	64	Phase 1;Phase 2	NULL
3	EUCTR2019-000638-20-BG (EUCTR)	09/11/2020	14/08/2020	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: ELSUBRUTINIB Other descriptive name: ABBV-105 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	325	Phase 2	United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
4	EUCTR2019-003323-38-GB (EUCTR)	06/11/2020	13/10/2020	A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851	Eli Lilly & Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of
5	EUCTR2019-003323-38-HU (EUCTR)	04/11/2020	10/09/2020	A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY3471851 Product Code: LY3471851 INN or Proposed INN: Not applicable Other descriptive name: LY3471851	Eli Lilly & Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;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
6	NCT04515719 (ClinicalTrials.gov)	November 1, 2020	13/8/2020	Efficacy and Safety of Belimumab in SLE Patients	Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity	Systemic Lupus Erythematosus	Biological: Belimumab;Biological: Placebo	RenJi Hospital	NULL	Not yet recruiting	18 Years	70 Years	All	334	Phase 4	NULL
7	NCT04582136 (ClinicalTrials.gov)	November 2020	3/10/2020	Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus	Efficacy and Safety of Sirolimus in Patients With Active Systemic Lupus Erythematosus Despite Standard of Care: a Multi-center, Double Blinded, Randomized, Placebo-controlled, Phase 2 Trial	Systemic Lupus Erythematosus	Drug: Sirolimus;Drug: Placebo	Chinese SLE Treatment And Research Group	Beijing Municipal Science & Technology Commission;North China Pharmaceutical Group Corporation	Not yet recruiting	18 Years	65 Years	All	146	Phase 2	NULL
8	EUCTR2019-002205-22-FR (EUCTR)	01/10/2020	13/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
9	NCT04516408 (ClinicalTrials.gov)	October 1, 2020	13/8/2020	Recombinant Zoster Vaccine in Stable SLE Patients	Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)	Herpes Zoster;Recombinant Zoster Vaccine;Systemic Lupus Erythematosus	Biological: Recombinant zoster vaccine;Biological: Placebo	RenJi Hospital	NULL	Not yet recruiting	50 Years	N/A	All	464	N/A	NULL
10	NCT00775476 (ClinicalTrials.gov)	October 2020	17/10/2008	Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine	Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC)	Systemic Lupus Erythematosus	Drug: N-acetylcysteine;Drug: Placebo	State University of New York - Upstate Medical University	NULL	Not yet recruiting	18 Years	N/A	All	290	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
11	EUCTR2019-003406-27-DE (EUCTR)	17/09/2020	15/04/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United States;Serbia;Portugal;Philippines;Estonia;Taiwan;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
12	EUCTR2019-003406-27-AT (EUCTR)	11/09/2020	29/05/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
13	EUCTR2019-003406-27-GB (EUCTR)	09/09/2020	15/07/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
14	EUCTR2019-002205-22-DE (EUCTR)	12/08/2020	07/07/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
15	NCT04294667 (ClinicalTrials.gov)	August 12, 2020	27/2/2020	A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: DZP;Other: Placebo	UCB Biopharma SRL	NULL	Recruiting	16 Years	N/A	All	450	Phase 3	United States;Bulgaria;Canada;Chile;Hungary;Poland;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	NCT04433585 (ClinicalTrials.gov)	August 7, 2020	15/6/2020	A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)	A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: LY3471851;Drug: Placebo	Eli Lilly and Company	Nektar Therapeutics	Recruiting	18 Years	65 Years	All	280	Phase 2	United States;Argentina;Australia;Canada;Czechia;Germany;Hungary;India;Israel;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom
17	EUCTR2019-003406-27-GR (EUCTR)	30/07/2020	02/06/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
18	EUCTR2018-001808-11-GR (EUCTR)	29/07/2020	16/07/2020	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus	Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441	Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 2	United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Georgia;Bulgaria;Germany;China
19	EUCTR2019-003406-27-HU (EUCTR)	28/07/2020	20/05/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
20	NCT04451772 (ClinicalTrials.gov)	July 17, 2020	29/6/2020	A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State	A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)	Systemic Lupus Erythematosus (SLE)	Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for Upadacitinib	AbbVie	NULL	Enrolling by invitation	18 Years	65 Years	All	260	Phase 2	United States;Argentina;Bulgaria;China;Germany;Hungary;Japan;Mexico;Netherlands;Poland;Puerto Rico;Spain;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
21	NCT04060888 (ClinicalTrials.gov)	July 14, 2020	16/8/2019	A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: Placebo	Janssen Research & Development, LLC	NULL	Withdrawn	18 Years	75 Years	All	0	Phase 3	China
22	NCT04305197 (ClinicalTrials.gov)	June 29, 2020	10/3/2020	A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)	A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: ICP-022;Drug: Placebos	Beijing InnoCare Pharma Tech Co., Ltd.	NULL	Recruiting	18 Years	75 Years	All	60	Phase 1;Phase 2	China
23	EUCTR2019-003406-27-BG (EUCTR)	09/06/2020	21/04/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
24	EUCTR2019-003406-27-ES (EUCTR)	02/06/2020	28/05/2020	A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SRL	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	450	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden
25	EUCTR2019-002205-22-GB (EUCTR)	01/05/2020	07/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Poland;Belgium;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
26	EUCTR2019-002205-22-ES (EUCTR)	06/04/2020	23/01/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
27	EUCTR2019-002205-22-PL (EUCTR)	29/03/2020	07/02/2020	Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.	SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185	Phase 2	United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom
28	NCT04058028 (ClinicalTrials.gov)	February 19, 2020	30/7/2019	Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)	A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy	Systemic Lupus Erythematosus (SLE)	Drug: AMG 570;Drug: Placebo for AMG 570	Amgen	NULL	Recruiting	18 Years	75 Years	All	300	Phase 2	United States;Argentina;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation
29	EUCTR2019-000638-20-NL (EUCTR)	07/02/2020	09/12/2019	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: ABBV-105 INN or Proposed INN: N/A Other descriptive name: ABBV-105 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	325	Phase 2	United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
30	EUCTR2019-000638-20-DE (EUCTR)	22/01/2020	09/09/2019	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: Elsubrutinib Other descriptive name: ABBV-105 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	325	Phase 2	United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand;China;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
31	NCT04186871 (ClinicalTrials.gov)	January 7, 2020	28/11/2019	Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis	A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis	Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome	Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	65 Years	All	185	Phase 2	United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom
32	EUCTR2018-004175-12-GB (EUCTR)	30/12/2019	23/07/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 Product Code: PF-06700841 25mg 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	448	Phase 2	Hong Kong;Greece;Spain;Ukraine;Colombia;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of;United States;Serbia;Portugal;Taiwan
33	EUCTR2018-004175-12-PT (EUCTR)	25/11/2019	30/07/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	448	Phase 2	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
34	EUCTR2018-004175-12-ES (EUCTR)	12/11/2019	11/11/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Pfizer Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	448	Phase 2	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
35	EUCTR2017-005026-37-HR (EUCTR)	24/10/2019	20/01/2020	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;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
36	NCT04275193 (ClinicalTrials.gov)	October 22, 2019	12/2/2020	The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus	The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Zishenqing;Drug: Placebo	Shanghai University of Traditional Chinese Medicine	RenJi Hospital	Recruiting	18 Years	65 Years	All	118	Phase 2;Phase 3	China
37	EUCTR2018-004175-12-BG (EUCTR)	11/10/2019	30/07/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 Product Code: PF-06700841 25mg 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	448	Phase 2	Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
38	NCT04082416 (ClinicalTrials.gov)	October 10, 2019	1/9/2019	Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)	A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy	RemeGen	NULL	Recruiting	18 Years	65 Years	All	318	Phase 3	China
39	EUCTR2018-001808-11-DE (EUCTR)	04/10/2019	18/10/2018	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus	Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod	Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 2	United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
40	EUCTR2018-004175-12-HU (EUCTR)	23/09/2019	23/07/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 Product Code: PF-06700841 25mg 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	448	Phase 2	United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;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
41	EUCTR2019-000638-20-HU (EUCTR)	18/09/2019	02/10/2019	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Elsubrutinib Product Code: ABBV-105 INN or Proposed INN: ELSUBRUTINIB Other descriptive name: ABBV-105 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	325	Phase 2	United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of
42	NCT04077684 (ClinicalTrials.gov)	September 10, 2019	1/9/2019	Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial	Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial	Systemic Lupus Erythematosus	Drug: Interleukin-2	Peking University People's Hospital	NULL	Recruiting	18 Years	75 Years	All	500	Phase 2	China
43	EUCTR2019-000638-20-ES (EUCTR)	09/09/2019	27/09/2019	A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		AbbVie Deutschland GmbH & Co. KG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	325	Phase 2	United States;Taiwan;Spain;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Germany;New Zealand;Japan;China;Korea, Republic of
44	EUCTR2018-004175-12-PL (EUCTR)	03/09/2019	06/08/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 Product Code: PF-06700841 25mg 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	448	Phase 2	Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
45	ChiCTR1900025376	2019-09-01	2019-08-25	Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial	Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial	systemic lupus erythematosus	intervention group:lenalidomide 10mg qd;control group:placebo 10mg qd;	Chinese Academy of Medical Sciences Peking Union Medical College Hospital	NULL	Recruiting	18	70	Both	intervention group:15;control group:15;	Phase 4	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
46	EUCTR2018-004175-12-CZ (EUCTR)	21/08/2019	25/07/2019	A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: PF-06700841 Product Code: PF-06700841 5mg INN or Proposed INN: PF-06700841 Other descriptive name: PF-06700841 -15 Product Name: PF-06700841 Product Code: PF-06700841 25mg 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	448	Phase 2	Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan
47	EUCTR2017-005026-37-NL (EUCTR)	06/08/2019	13/05/2019	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China
48	EUCTR2017-005026-37-GR (EUCTR)	26/07/2019	03/05/2019	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China
49	NCT03978520 (ClinicalTrials.gov)	July 25, 2019	3/6/2019	A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)	A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for upadacitinib	AbbVie	NULL	Recruiting	18 Years	65 Years	All	310	Phase 2	United States;Argentina;Australia;Bulgaria;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom
50	NCT03951259 (ClinicalTrials.gov)	July 24, 2019	14/5/2019	Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus	A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: SM934;Drug: Placebos	RenJi Hospital	Jiangsu ZuoYou Medicine Co., Ltd.	Recruiting	18 Years	70 Years	All	48	Phase 2	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
51	EUCTR2017-001203-79-ES (EUCTR)	11/06/2019	30/04/2019	A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;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	360	Phase 2	United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of
52	NCT03804723 (ClinicalTrials.gov)	June 2019	11/1/2019	Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus	Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial	Systemic Lupus Erythematosus;Glucocorticoids;Therapy Withdrawal	Drug: oral Prednisone 5mg	University of Pisa	NULL	Not yet recruiting	18 Years	85 Years	All	321	N/A	NULL
53	NCT03933943 (ClinicalTrials.gov)	May 21, 2019	30/4/2019	A Study of LY3361237 in Participants With Systemic Lupus Erythematosus	A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: LY3361237;Drug: Placebo	Eli Lilly and Company	NULL	Recruiting	18 Years	70 Years	All	24	Phase 1	United States
54	EUCTR2018-001808-11-PL (EUCTR)	17/05/2019	15/05/2019	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus	Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod	Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 2	United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Turkey;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
55	NCT03949426 (ClinicalTrials.gov)	May 1, 2019	8/5/2019	Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects	A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818	Systemic Lupus Erythematosus	Drug: KPG-818	Kangpu Biopharmaceuticals, Ltd.	NULL	Completed	18 Years	55 Years	All	40	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
56	NCT03845517 (ClinicalTrials.gov)	April 18, 2019	15/2/2019	A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	Systemic Lupus Erythematosus	Drug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mg	Pfizer	NULL	Recruiting	18 Years	75 Years	All	448	Phase 2	United States;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Mexico;Poland;Portugal;Romania;Serbia;Spain;Taiwan;Ukraine;United Kingdom
57	NCT03917797 (ClinicalTrials.gov)	April 2, 2019	2/4/2019	Mesenchymal Stromal Cells (MSC´s) in Renal Lupus	Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic;Lupus Glomerulonephritis	Biological: MSC treatment;Drug: Standard of Care;Drug: Placebo	Universidad de los Andes, Chile	NULL	Recruiting	18 Years	75 Years	All	39	Phase 2	Chile
58	EUCTR2017-005026-37-GB (EUCTR)	27/03/2019	19/09/2018	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
59	EUCTR2018-001808-11-BG (EUCTR)	20/03/2019	06/12/2018	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus	Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 2	United States;Taiwan;Spain;Thailand;Ukraine;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
60	NCT03771885 (ClinicalTrials.gov)	March 16, 2019	10/12/2018	BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)	A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus.	Lupus Erythematosus, Systemic	Drug: BI 705564;Drug: Placebo	Boehringer Ingelheim	NULL	Withdrawn	18 Years	N/A	All	0	Phase 1	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
61	ChiCTR1900020803	2019-03-01	2019-01-19	Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial	Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial	systemic lupus erythematosus	intervention group:melatonin 6mg qn;control group:placebo qn;	Chinese Academy of Medical Sciences Peking Union Medical College Hospital	NULL	Pending	18	65	Both	intervention group:88;control group:88;	Phase 4	China
62	EUCTR2018-001808-11-HU (EUCTR)	08/02/2019	22/11/2018	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)	Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod	Idorsia Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 2	United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
63	EUCTR2018-001508-12-FR (EUCTR)	05/02/2019	13/11/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
64	EUCTR2017-001489-53-PT (EUCTR)	04/02/2019	08/11/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
65	EUCTR2018-001808-11-ES (EUCTR)	24/01/2019	16/11/2018	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)	Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 2	United States;Hong Kong;Taiwan;Spain;Thailand;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;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	EUCTR2018-001808-11-FR (EUCTR)	14/01/2019	31/08/2018	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE)	Moderate to severe systemic lupus erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod	Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 2	United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China
67	NCT03742037 (ClinicalTrials.gov)	December 21, 2018	12/11/2018	Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus	A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: Placebo	Idorsia Pharmaceuticals Ltd.	NULL	Recruiting	18 Years	75 Years	All	500	Phase 2	United States;Bulgaria;Czechia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Lithuania
68	NCT03656562 (ClinicalTrials.gov)	December 19, 2018	19/7/2018	Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients	A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE)	Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo	Novartis Pharmaceuticals	NULL	Recruiting	18 Years	75 Years	All	120	Phase 2	Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand
69	EUCTR2017-005026-37-AT (EUCTR)	18/12/2018	25/09/2018	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
70	EUCTR2018-001808-11-GB (EUCTR)	17/12/2018	17/09/2018	A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease	A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus	Moderate to severe systemic lupus erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441 Product Name: Cenerimod Product Code: ACT-334441 INN or Proposed INN: Cenerimod Other descriptive name: ACT-334441	Idorsia Pharmaceuticals Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	325	Phase 2	United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Poland;Romania;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
71	EUCTR2017-005026-37-BE (EUCTR)	17/12/2018	25/09/2018	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Brazil;Australia;Netherlands;Germany;China
72	NCT03817424 (ClinicalTrials.gov)	December 13, 2018	22/1/2019	A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis	A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis	Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis	Drug: VIB7734;Drug: Placebo	Viela Bio	NULL	Completed	18 Years	75 Years	All	31	Phase 1	United States;Poland;Spain
73	EUCTR2018-001508-12-ES (EUCTR)	12/12/2018	09/10/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	Systemic lupus erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Novartis Farmacéutica, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 2	Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
74	EUCTR2018-001508-12-DE (EUCTR)	05/12/2018	28/08/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE)	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 Product Code: CFZ533 INN or Proposed INN: iscalimab Other descriptive name: CFZ533	Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	135	Phase 2	Taiwan;Thailand;Spain;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
75	NCT03878303 (ClinicalTrials.gov)	November 28, 2018	5/3/2019	Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)	A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: AC0058TA;Drug: Placebo AC0058TA	ACEA Therapeutics, Inc.	Hangzhou ACEA Pharmaceutical Research Co., Ltd.	Recruiting	18 Years	75 Years	All	32	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
76	NCT03724916 (ClinicalTrials.gov)	November 26, 2018	18/10/2018	A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)	A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus	Systemic Lupus Erythematosus;Lupus Erythematosus, Systemic	Drug: TAK-079;Drug: TAK-079 Placebo	Millennium Pharmaceuticals, Inc.	NULL	Recruiting	18 Years	75 Years	All	24	Phase 1	United States
77	EUCTR2017-005026-37-HU (EUCTR)	19/11/2018	25/09/2018	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
78	EUCTR2017-005026-37-CZ (EUCTR)	12/11/2018	26/10/2018	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	825	Phase 3	United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
79	EUCTR2018-001508-12-CZ (EUCTR)	02/11/2018	28/08/2018	Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)	Systemic lupus erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Novartis Pharma AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	135	Phase 2	Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of
80	NCT02633163 (ClinicalTrials.gov)	October 26, 2018	15/12/2015	Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)	A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus	Systemic Lupus Erythematosus	Drug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo Infusion	Medical University of South Carolina	NULL	Recruiting	18 Years	65 Years	All	81	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
81	NCT03626311 (ClinicalTrials.gov)	October 23, 2018	6/6/2018	Omega-3 Replacement With Krill Oil in Disease Management of SLE	A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE)	Dietary Supplement: AKBM-3031;Other: Placebo	Aker Biomarine Antarctic AS	Ampel BioSolutions, LLC	Recruiting	18 Years	N/A	All	76	N/A	United States;Canada
82	EUCTR2017-001489-53-PL (EUCTR)	24/09/2018	23/07/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
83	EUCTR2017-005027-25-ES (EUCTR)	21/09/2018	24/09/2018	A study of Baricitinib in patients with Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Trade Name: Olumiant Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	750	Phase 3	Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France
84	NCT03527472 (ClinicalTrials.gov)	August 23, 2018	3/5/2018	Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus	A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Memantine;Drug: Placebo	Vanderbilt University Medical Center	Kleberg Foundation	Active, not recruiting	18 Years	60 Years	All	46	Phase 2	United States
85	JPRN-JapicCTI-183973	16/8/2018	29/05/2018	A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Intervention name : Ustekinumab INN of the intervention : Ustekinumab Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160 Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.	Janssen Pharmaceutical K.K.	NULL	complete	16	75	BOTH	500	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Africa
No.	TrialID	Date_ enrollment	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	NCT03616912 (ClinicalTrials.gov)	August 2, 2018	1/8/2018	A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Baricitinib;Drug: Placebo	Eli Lilly and Company	Incyte Corporation	Recruiting	18 Years	N/A	All	809	Phase 3	United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine
87	NCT03616964 (ClinicalTrials.gov)	August 2, 2018	1/8/2018	A Study of Baricitinib in Participants With Systemic Lupus Erythematosus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Baricitinib;Drug: Placebo	Eli Lilly and Company	Incyte Corporation	Active, not recruiting	18 Years	N/A	All	750	Phase 3	United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain
88	EUCTR2017-001489-53-BG (EUCTR)	27/06/2018	28/03/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
89	EUCTR2017-001489-53-HU (EUCTR)	14/06/2018	03/04/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
90	EUCTR2017-001489-53-ES (EUCTR)	12/06/2018	14/03/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;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
91	NCT03541564 (ClinicalTrials.gov)	May 30, 2018	17/5/2018	An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects	A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects	Systemic Lupus Erythematosus;Healthy Participants	Drug: BMS-986165;Drug: Moxifloxacin;Other: Placebo	Bristol-Myers Squibb	NULL	Completed	18 Years	50 Years	All	84	Phase 1	United States
92	EUCTR2016-000488-17-FR (EUCTR)	16/05/2018	19/03/2019	A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)	A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)	Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2	ILTOO PHARMA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Portugal;France;Mexico;Spain;Austria;Bulgaria;Italy
93	EUCTR2017-001489-53-DE (EUCTR)	08/05/2018	23/03/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
94	EUCTR2017-001489-53-LT (EUCTR)	07/05/2018	19/03/2018	Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB Trade Name: Stelara INN or Proposed INN: ustekinumab Other descriptive name: USTEKINUMAB	Janssen-Cilag International NV	NULL	Not Recruiting			Female: yes Male: yes	500	Phase 3	United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of
95	NCT03556007 (ClinicalTrials.gov)	May 1, 2018	7/5/2018	A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)	A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: LY3471851;Drug: Placebo	Eli Lilly and Company	Nektar Therapeutics	Completed	18 Years	70 Years	All	48	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
96	NCT03517722 (ClinicalTrials.gov)	April 16, 2018	13/4/2018	A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mg	Janssen Research & Development, LLC	NULL	Active, not recruiting	16 Years	75 Years	All	516	Phase 3	United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania
97	NCT03451422 (ClinicalTrials.gov)	April 10, 2018	1/2/2018	Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of AMG 592 in Participants With Systemic Lupus Erythematosus	A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of AMG 592 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: AMG 592;Drug: Placebo	Amgen	NULL	Recruiting	18 Years	70 Years	All	29	Phase 1	United States;France;Germany;Poland
98	NCT03312907 (ClinicalTrials.gov)	March 1, 2018	13/10/2017	A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper	GlaxoSmithKline	NULL	Active, not recruiting	18 Years	N/A	All	292	Phase 3	United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain
99	NCT03396393 (ClinicalTrials.gov)	March 2018	4/1/2018	Exploratory Study of DHA in Systemic Lupus Erythematosus Patients	A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Dihydroartemisinin tablet;Drug: Placebo tablet	Kunming Pharmaceuticals, Inc.	NULL	Not yet recruiting	18 Years	65 Years	All	120	Phase 2	NULL
100	EUCTR2016-003050-32-NL (EUCTR)	16/02/2018	24/10/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;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
101	NCT03371251 (ClinicalTrials.gov)	February 7, 2018	8/12/2017	Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care	A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care	Systemic Lupus Erythematosus	Drug: BOS161721;Drug: Placebo	Boston Pharmaceuticals	NULL	Completed	18 Years	70 Years	All	143	Phase 1;Phase 2	United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine
102	EUCTR2016-003050-32-DE (EUCTR)	09/01/2018	21/06/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of
103	EUCTR2017-001203-79-PL (EUCTR)	05/01/2018	03/11/2017	A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165	Bristol-Myers Squibb International Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	360	Phase 2	Taiwan;Russian Federation;Israel;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Spain;Colombia;Korea, Republic of;United States
104	NCT03030118 (ClinicalTrials.gov)	December 28, 2017	15/1/2017	Study of Anti-Malarials in Incomplete Lupus Erythematosus	Study of Anti-Malarials in Incomplete Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule	Milton S. Hershey Medical Center	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Recruiting	15 Years	49 Years	All	240	Phase 2	United States
105	NCT03093402 (ClinicalTrials.gov)	December 21, 2017	21/2/2017	JBT-101 in Systemic Lupus Erythematosus (SLE)	A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (ALE09)	Systemic Lupus Erythematosus;SLE;Lupus	Drug: JBT-101;Drug: Placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Corbus Pharmaceuticals Inc.;Autoimmunity Centers of Excellence	Recruiting	18 Years	70 Years	All	100	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
106	EUCTR2016-003050-32-ES (EUCTR)	05/12/2017	01/12/2017	A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus (SLE) or Lupus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	200	Phase 3	United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of
107	EUCTR2017-001203-79-HU (EUCTR)	04/12/2017	04/10/2017	A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000017968;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: BMS-986165 Product Code: BMS-986165 INN or Proposed INN: BMS-986165	Bristol-Myers Squibb international Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	400	Phase 2	United States;Taiwan;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of
108	EUCTR2016-004574-17-FR (EUCTR)	30/11/2017	28/11/2018	A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
109	NCT03334851 (ClinicalTrials.gov)	November 17, 2017	3/11/2017	Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis	A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS	Systemic Lupus Erythematosus;Rheumatoid Arthritis	Drug: PF-06835375;Drug: Placebo	Pfizer	NULL	Recruiting	18 Years	70 Years	All	112	Phase 1	United States;Puerto Rico
110	EUCTR2016-004574-17-BE (EUCTR)	14/11/2017	07/06/2017	A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;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
111	EUCTR2016-004574-17-DE (EUCTR)	27/09/2017	21/04/2017	A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220	Celgene Corporation	NULL	Not Recruiting			Female: yes Male: yes	280	Phase 2	Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
112	NCT03054259 (ClinicalTrials.gov)	September 21, 2017	17/1/2017	Rituximab Objective Outcome Measures Trial in SLE	A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus	Systemic Lupus Erythematosus Arthritis	Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline	University of Leeds	NULL	Recruiting	18 Years	99 Years	All	30	Phase 2	United Kingdom
113	NCT03161483 (ClinicalTrials.gov)	July 6, 2017	18/5/2017	A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	Lupus Erythematosus, Systemic	Drug: CC -220;Other: Placebo	Celgene	NULL	Active, not recruiting	18 Years	N/A	All	289	Phase 2	United States;Argentina;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;Spain
114	NCT03189017 (ClinicalTrials.gov)	July 3, 2017	12/6/2017	A Phase I Study of ICP-022 in Healthy Subjects	A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose	Systemic Lupus Erythematosus;Rheumatoid Arthritis	Drug: ICP-022;Drug: Placebos	Innocare Pharma Australia Pty Ltd	NULL	Completed	18 Years	55 Years	Male	64	Phase 1	Australia
115	NCT02920424 (ClinicalTrials.gov)	June 30, 2017	29/9/2016	A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus	A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: JNJ-56022473;Drug: Placebo	Janssen Research & Development, LLC	NULL	Withdrawn	18 Years	65 Years	All	0	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
116	EUCTR2016-002950-19-DE (EUCTR)	19/06/2017	12/04/2017	A Phase II Study of M2951 in SLE	A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A	Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	468	Phase 2	United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
117	EUCTR2016-004574-17-HU (EUCTR)	19/06/2017	13/04/2017	A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220	Celgene Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany
118	NCT03252587 (ClinicalTrials.gov)	June 13, 2017	15/8/2017	An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: BMS-986165;Other: Placebo	Bristol-Myers Squibb	NULL	Recruiting	18 Years	75 Years	All	360	Phase 2	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine
119	EUCTR2015-004359-32-PL (EUCTR)	10/06/2017	24/04/2017	Study to Evaluate BIIB059 in CLE with or without SLE	A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations.	Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of
120	EUCTR2016-004574-17-ES (EUCTR)	08/06/2017	07/04/2017	A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220 Product Code: CC -220 INN or Proposed INN: CC -220 Other descriptive name: CC -220	Celgene Corporation	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 2	Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;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
121	EUCTR2016-000625-39-BG (EUCTR)	17/05/2017	08/03/2017	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
122	EUCTR2016-002950-19-BG (EUCTR)	27/04/2017	27/03/2017	A Phase II Study of M2951 in SLE	A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A	Systemic Lupus Erythematosus (SLE) MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Evobrutinib Product Code: M2951 INN or Proposed INN: Evobrutinib Other descriptive name: M2951	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	468	Phase 2	United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;Bulgaria;South Africa;Germany;Japan;Korea, Republic of
123	JPRN-JapicCTI-173544	26/4/2017	23/03/2017	TULIP SLE LTE	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Intervention name : Anifrolumab INN of the intervention : anifrolumab Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses	AstraZeneca	NULL	complete	18		BOTH	50	Phase 3	Japan, Asia except Japan, North America, South America, Europe, Oceania
124	EUCTR2016-002950-19-PL (EUCTR)	25/04/2017	28/03/2017	A Phase II Study of M2951 in SLE	A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A	Systemic Lupus Erythematosus (SLE) MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Merck KGaA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	468	Phase 2	United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Malaysia;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of
125	EUCTR2015-001341-86-BG (EUCTR)	10/04/2017	16/02/2017	Phase IIb study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 19.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance	Neovacs S.A.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;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
126	NCT03355482 (ClinicalTrials.gov)	April 10, 2017	22/11/2017	MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE	MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE	Systemic Lupus Erythematosus Arthritis	Drug: Methylprednisolone;Drug: Placebos	Oklahoma Medical Research Foundation	Bristol-Myers Squibb	Recruiting	18 Years	70 Years	All	40	Phase 2	United States
127	EUCTR2016-001039-11-DE (EUCTR)	03/04/2017	22/12/2016	A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
128	EUCTR2016-000488-17-BG (EUCTR)	27/03/2017	13/02/2017	A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)	A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)	Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: Aldesleukin Other descriptive name: INTERLEUKIN-2	ILTOO PHARMA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Portugal;France;Mexico;Spain;Romania;Austria;Bulgaria;Germany;Italy
129	EUCTR2016-000488-17-IT (EUCTR)	02/03/2017	10/05/2019	A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)	A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) - A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage o	Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: ILT-101 Product Code: ILT-101 INN or Proposed INN: ALDESLEUCHINA Other descriptive name: ALDESLEUCHINA	ILTOO PHARMA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	France;Portugal;Spain;Austria;Bulgaria;Italy
130	NCT03042260 (ClinicalTrials.gov)	March 1, 2017	10/1/2017	Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous	Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial	Lupus Erythematosus, Systemic	Drug: Trimethoprim -Sulfamethoxazole;Drug: Placebo Oral Tablet	Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	National Council of Science and Technology, Mexico	Recruiting	18 Years	N/A	All	310	Phase 4	Mexico
No.	TrialID	Date_ enrollment	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	EUCTR2015-001341-86-ES (EUCTR)	01/03/2017	27/12/2016	Phase IIb study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance	Neovacs S.A.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
132	EUCTR2016-001039-11-BG (EUCTR)	20/02/2017	08/11/2016	A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITHMODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: GDC-0853 Product Code: RO7010939/F13 INN or Proposed INN: not available yet Other descriptive name: GDC-0853 RO7010939	Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
133	NCT02962960 (ClinicalTrials.gov)	February 14, 2017	23/9/2016	A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.	Systemic Lupus Erythematosus	Drug: Anifrolumab;Drug: Placebo	AstraZeneca	NULL	Completed	18 Years	70 Years	All	36	Phase 2	United States;Hungary;Korea, Republic of;Poland
134	EUCTR2016-001039-11-ES (EUCTR)	07/02/2017	26/10/2016	A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
135	EUCTR2015-004359-32-BG (EUCTR)	01/02/2017	03/11/2016	Study to Evaluate BIIB059 in CLE with or without SLE	A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations.	Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BIIB059 Product Code: BIIB059 INN or Proposed INN: Not Available Other descriptive name: anti-blood dendritic cell antigen 2	Biogen Idec Research Limited	NULL	Not Recruiting			Female: yes Male: yes	320	Phase 2	United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;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
136	EUCTR2016-001039-11-PT (EUCTR)	30/01/2017	23/09/2016	A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
137	EUCTR2016-003246-93-PL (EUCTR)	26/01/2017	13/12/2016	The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations	Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: ANIFROLUMAB Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer	Astrazeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	32	Phase 2	United States;Hungary;Poland;Korea, Republic of
138	JPRN-JapicCTI-183957	20/1/2017	14/05/2018	A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)	A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period. Intervention name : M2951 (Other Name: Evobrutinib) INN of the intervention : - Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period.	Merck Biopharma Co., Ltd	Merck KGaA	complete	18	75	BOTH	480	Phase 2	Japan, Asia except Japan, North America, South America, Europe, Africa
139	NCT02908100 (ClinicalTrials.gov)	January 19, 2017	14/9/2016	A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus	A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: GDC-0853;Drug: Placebo	Genentech, Inc.	NULL	Completed	18 Years	75 Years	All	260	Phase 2	United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;France;Portugal;Thailand
140	NCT02955615 (ClinicalTrials.gov)	January 18, 2017	17/10/2016	ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)	A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: ILT-101;Drug: Placebo	Iltoo Pharma	NULL	Completed	18 Years	N/A	All	100	Phase 2	Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;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
141	NCT02975336 (ClinicalTrials.gov)	January 4, 2017	23/11/2016	A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)	A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Placebo;Drug: M2951	EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany	Terminated	18 Years	75 Years	All	480	Phase 2	United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan
142	NCT02953821 (ClinicalTrials.gov)	December 16, 2016	1/11/2016	Acthar Gel for Active Systemic Lupus Erythematosus (SLE)	A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids	Lupus Erythematosus, Systemic	Drug: Acthar Gel;Drug: Placebo Gel	Mallinckrodt	NULL	Completed	18 Years	N/A	All	172	Phase 4	United States;Argentina;Chile;Mexico;Peru;Colombia
143	EUCTR2016-000625-39-DE (EUCTR)	13/12/2016	05/07/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
144	EUCTR2016-003246-93-HU (EUCTR)	06/12/2016	19/10/2016	The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.	A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations	Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Astrazeneca AB	NULL	Not Recruiting			Female: yes Male: yes	32	Phase 2	United States;Hungary;Poland;Korea, Republic of
145	EUCTR2016-000488-17-ES (EUCTR)	21/11/2016	18/11/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)	A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)	Systematic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		ILTOO PHARMA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	France;Portugal;Mexico;Spain;Austria;Bulgaria;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
146	EUCTR2016-001039-11-GB (EUCTR)	16/11/2016	24/08/2016	A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus	A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Genentech, Inc.	NULL	Not Recruiting			Female: yes Male: yes	240	Phase 2	United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of
147	EUCTR2015-004457-40-PL (EUCTR)	04/11/2016	02/09/2016	A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.	A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
148	EUCTR2016-000625-39-LT (EUCTR)	03/11/2016	17/08/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan
149	EUCTR2016-000488-17-PT (EUCTR)	24/10/2016	28/07/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)	A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)	Systematic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		ILTOO PHARMA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	France;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
150	NCT02847598 (ClinicalTrials.gov)	October 20, 2016	6/6/2016	Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)	A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations	Systemic Lupus Erythematosus;Active Cutaneous Lupus Erythematosus	Drug: BIIB059;Drug: Placebo	Biogen	NULL	Completed	18 Years	75 Years	All	264	Phase 2	United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand
No.	TrialID	Date_ enrollment	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	EUCTR2015-003341-25-GB (EUCTR)	17/10/2016	22/09/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.	A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		ImmuPharma SA	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Hungary;Germany;United Kingdom
152	EUCTR2015-004457-40-ES (EUCTR)	10/10/2016	05/08/2016	A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.	A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS.	SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS. MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657 Product Name: Dapirolizumab pegol (DZP) Product Code: CDP7657 INN or Proposed INN: Dapirolizumab pegol Other descriptive name: CDP7657	UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
153	EUCTR2015-004457-40-HU (EUCTR)	20/09/2016	13/07/2016	A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.	A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
154	EUCTR2015-004457-40-DE (EUCTR)	19/09/2016	22/06/2016	A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.	A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany
155	EUCTR2015-004457-40-BG (EUCTR)	13/09/2016	03/08/2016	A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.	A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS	SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]		UCB Biopharma SPRL	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 2	United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;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
156	EUCTR2016-000625-39-ES (EUCTR)	24/08/2016	15/07/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
157	EUCTR2016-000625-39-HU (EUCTR)	18/08/2016	23/06/2016	A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab Product Code: MEDI-546 INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	575	Phase 3	United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand
158	EUCTR2016-000488-17-AT (EUCTR)	08/08/2016	21/07/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)	A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE)	Systematic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		ILTOO PHARMA	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	Portugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy
159	EUCTR2015-003341-25-DE (EUCTR)	29/07/2016	17/03/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.	A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		ImmuPharma SA	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Hungary;Germany;United Kingdom
160	NCT02794285 (ClinicalTrials.gov)	June 30, 2016	6/6/2016	Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus.	Active Systemic Lupus Erythematosus	Biological: Anifrolumab;Drug: Placebo	AstraZeneca	PRA Health Sciences	Active, not recruiting	18 Years	70 Years	All	559	Phase 3	United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore
No.	TrialID	Date_ enrollment	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	NCT03155477 (ClinicalTrials.gov)	June 10, 2016	13/5/2017	Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D	Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) Serum	SLE	Dietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placebo	Saiful Anwar Hospital	NULL	Completed	18 Years	45 Years	Female	39	N/A	NULL
162	NCT02804763 (ClinicalTrials.gov)	June 2, 2016	14/6/2016	A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus	A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Drug: Placebo;Drug: Dapirolizumab pegol (DZP)	UCB Biopharma S.P.R.L.	NULL	Completed	18 Years	N/A	All	182	Phase 2	United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine
163	NCT02514967 (ClinicalTrials.gov)	June 2016	31/7/2015	CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis	Systemic Lupus Erythematosus	Drug: Blisibimod;Drug: Placebo	Anthera Pharmaceuticals	NULL	Terminated	18 Years	N/A	All	3	Phase 3	Georgia
164	NCT02741960 (ClinicalTrials.gov)	May 24, 2016	7/4/2016	The Effect of Metformin on Reducing Lupus Flares	A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: metformin;Drug: placebo	RenJi Hospital	NULL	Completed	18 Years	70 Years	All	180	Phase 4	China
165	EUCTR2015-003341-25-HU (EUCTR)	02/05/2016	07/03/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.	A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.	Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: IPP-201101 INN or Proposed INN: IPP-201101	ImmuPharma SA	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	France;United States;Hungary;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
166	EUCTR2015-004404-35-ES (EUCTR)	29/04/2016	04/04/2016	A study in Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)	Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Lilly S.A.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of
167	EUCTR2015-004404-35-FR (EUCTR)	12/04/2016	04/05/2016	A study in Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)	Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of
168	EUCTR2015-004404-35-PL (EUCTR)	12/04/2016	31/03/2016	A study in Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)	Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of
169	EUCTR2015-004404-35-AT (EUCTR)	06/04/2016	24/03/2016	A study in Lupus	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)	Patients with Systemic Lupus Erythematosus (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB Product Name: Baricitinib Product Code: LY3009104 INN or Proposed INN: Baricitinib Other descriptive name: BARICITINIB	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of
170	NCT02331810 (ClinicalTrials.gov)	April 2016	5/12/2014	Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients	A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient	Systemic Lupus Erythematosus	Drug: SAR113244;Drug: placebo	Sanofi	NULL	Withdrawn	18 Years	75 Years	Both	0	Phase 1	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
171	NCT02618967 (ClinicalTrials.gov)	March 28, 2016	13/10/2015	Single Ascending Dose Study of AMG 570 in Healthy Subjects	A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects	Systemic Lupus Erythematosus	Biological: AMG 570;Biological: AMG 570 Matching Placebo	Amgen	NULL	Completed	18 Years	65 Years	All	56	Phase 1	United States
172	NCT02708095 (ClinicalTrials.gov)	March 24, 2016	10/3/2016	A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)	A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Baricitinib;Drug: Placebo	Eli Lilly and Company	NULL	Completed	18 Years	N/A	All	314	Phase 2	United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan
173	JPRN-JapicCTI-163359	01/3/2016		A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH	A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH	Systemic Lupus Erythematosus (SLE)	Intervention name : Baricitinib INN of the intervention : Baricitinib Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks Control intervention name : Placebo Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks	Eli Lilly Japan K.K.	NULL		18		BOTH		Phase 2	NULL
174	NCT02711813 (ClinicalTrials.gov)	March 2016	14/3/2016	TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment	Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy	Lupus Erythematosus, Systemic	Drug: TAB08;Other: Placebo	Theramab LLC	NULL	Terminated	18 Years	60 Years	All	60	Phase 2	Russian Federation
175	EUCTR2015-003341-25-FR (EUCTR)	24/02/2016	20/04/2016	A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.	A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Code: IPP-201101 INN or Proposed INN: IPP-201101	ImmuPharma SA	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;France;Hungary;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
176	NCT02725515 (ClinicalTrials.gov)	February 16, 2016	8/1/2016	A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus	A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity	Systemic Lupus Erythematosus	Biological: XmAb5871;Biological: Placebo to match XmAb5871	Xencor, Inc.	PPD;ICON plc	Completed	18 Years	65 Years	All	105	Phase 2	United States
177	NCT02660944 (ClinicalTrials.gov)	January 3, 2016	16/1/2016	A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)	A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: RSLV-132;Drug: Placebo	Resolve Therapeutics	NULL	Completed	18 Years	70 Years	All	64	Phase 2	United States
178	NCT02483624 (ClinicalTrials.gov)	January 2016	23/6/2015	3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus	A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)	SLE	Drug: BR-DIM;Drug: Placebo	North Shore Long Island Jewish Health System	NULL	Terminated	18 Years	50 Years	Female	6	Phase 1	NULL
179	EUCTR2014-002184-14-NL (EUCTR)	22/12/2015	03/09/2015	Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
180	EUCTR2014-004632-19-BG (EUCTR)	11/12/2015	27/10/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;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
181	NCT02074020 (ClinicalTrials.gov)	December 2015	26/2/2014	CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis	Systemic Lupus Erythematosus	Drug: Blisibimod;Drug: Placebo	Anthera Pharmaceuticals	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 3	NULL
182	NCT02885610 (ClinicalTrials.gov)	December 2015	26/8/2016	Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)	A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy	RemeGen	NULL	Completed	18 Years	65 Years	All	249	Phase 2	China
183	NCT02609789 (ClinicalTrials.gov)	December 2015	18/11/2015	A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus	A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus	Systemic Lupus Erythematosus;Healthy	Drug: JNJ-55920839;Drug: Placebo	Janssen Research & Development, LLC	NULL	Completed	18 Years	55 Years	All	72	Phase 1	United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan
184	NCT02537028 (ClinicalTrials.gov)	November 30, 2015	28/8/2015	MSC2364447C Phase 1b in Systemic Lupus Erythematosus	A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: MSC2364447C;Drug: Placebo	EMD Serono Research & Development Institute, Inc.	Merck KGaA	Completed	18 Years	65 Years	All	24	Phase 1	United States;Bulgaria
185	EUCTR2014-004633-96-RO (EUCTR)	26/11/2015	08/10/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;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
186	EUCTR2015-001341-86-DE (EUCTR)	19/11/2015	01/09/2015	Phase IIb study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Neovacs S.A.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
187	EUCTR2014-004632-19-DE (EUCTR)	12/11/2015	06/08/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of
188	EUCTR2014-004633-96-DE (EUCTR)	12/11/2015	28/05/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
189	NCT02477150 (ClinicalTrials.gov)	November 2015	17/6/2015	Safety and Immunogenicity of a Zoster Vaccine in SLE	Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial	Systemic Lupus Erythematosus	Biological: Zostavax;Biological: placebo	Tuen Mun Hospital	NULL	Completed	18 Years	N/A	All	90	Phase 4	China
190	EUCTR2015-001341-86-HR (EUCTR)	23/10/2015	10/11/2015	Phase IIb study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance	Neovas S.A.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of;United States;Philippines;Taiwan;Spain;Thailand;Russian Federation;Chile;Colombia;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
191	JPRN-JapicCTI-153077	21/10/2015	20/11/2015	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus Erythematosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Intervention name : Lulizumab pegol INN of the intervention : - Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Bristol-Myers Squibb K.K.	NULL	complete	18	70	BOTH	350	Phase 2	Japan, Asia except Japan, North America, South America, Europe
192	NCT02349061 (ClinicalTrials.gov)	October 15, 2015	23/1/2015	A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant Medication	Janssen Research & Development, LLC	NULL	Completed	18 Years	75 Years	All	102	Phase 2	United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom
193	EUCTR2014-004633-96-PL (EUCTR)	14/10/2015	05/08/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of
194	EUCTR2015-000372-95-DE (EUCTR)	08/10/2015	17/06/2015	Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus	A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY	Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody	Ablynx N.V.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
195	NCT02429934 (ClinicalTrials.gov)	October 2015	24/4/2015	Abatacept for SLE Arthritis (IM101-330)	Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus Arthritis	Drug: abatacept;Drug: Placebo	University of California, Los Angeles	Bristol-Myers Squibb	Terminated	18 Years	N/A	All	28	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
196	NCT02554019 (ClinicalTrials.gov)	September 28, 2015	16/9/2015	Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Biological: BT063;Biological: Placebo	Biotest	NULL	Completed	18 Years	75 Years	All	36	Phase 2	Belarus;Georgia;Poland;Serbia
197	EUCTR2015-000372-95-HU (EUCTR)	24/09/2015	30/06/2015	Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus	A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY	Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody	Ablynx N.V.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
198	EUCTR2014-004632-19-CZ (EUCTR)	23/09/2015	28/07/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anifrolumab INN or Proposed INN: Anifrolumab	AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
199	NCT02665364 (ClinicalTrials.gov)	September 23, 2015	17/11/2015	Phase IIb Study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Biological: IFNa-Kinoid;Other: Placebo;Other: ISA 51 VG	Neovacs	NULL	Terminated	18 Years	65 Years	All	185	Phase 2	United States;Argentina;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Switzerland;Taiwan;Thailand;Tunisia
200	EUCTR2014-005000-19-PL (EUCTR)	22/09/2015	18/08/2015	A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab Product Name: Ustekinumab Product Code: CNTO1275 INN or Proposed INN: ustekinumab	Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	102	Phase 2	United States;Hungary;Taiwan;Mexico;Argentina;Spain;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
201	EUCTR2014-004632-19-ES (EUCTR)	21/09/2015	24/06/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
202	EUCTR2015-001341-86-IT (EUCTR)	19/09/2015	10/11/2020	Phase IIb study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Neutralization of the Interferon Gene Signature and theClinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic LupusErythematosus - IFN-K-002	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: IFN-Kinoid Product Code: IFN-K	NEOVACS	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	United States;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of
203	EUCTR2014-004633-96-IT (EUCTR)	16/09/2015	21/01/2020	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		ASTRAZENECA AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
204	EUCTR2014-005526-35-PL (EUCTR)	12/09/2015	10/08/2015	Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)	A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)	Systemic Lupus Erythematosus MedDRA version: 19.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: BT063 Product Code: BT063 INN or Proposed INN: BT063 Other descriptive name: BT063	Biotest AG	NULL	Not Recruiting			Female: yes Male: yes	36	Phase 2	Serbia;Belarus;Poland;Georgia
205	EUCTR2015-000372-95-PT (EUCTR)	11/09/2015	26/06/2015	Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus	A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY	Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Ablynx N.V.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;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
206	EUCTR2014-004632-19-BE (EUCTR)	07/09/2015	23/06/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of
207	EUCTR2015-001341-86-BE (EUCTR)	07/09/2015	03/09/2015	Phase IIb study of IFN-K in Systemic Lupus Erythematosus	A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: IFN-Kinoid Product Code: IFN-K INN or Proposed INN: Not yet assigned Other descriptive name: IFN-Kinoid Drug Substance	Neovacs S.A.	NULL	Not Recruiting			Female: yes Male: yes	178	Phase 2	Serbia;United States;Philippines;Taiwan;Spain;Thailand;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Georgia;Bulgaria;Germany
208	EUCTR2014-004633-96-HU (EUCTR)	02/09/2015	29/06/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
209	NCT02535689 (ClinicalTrials.gov)	August 28, 2015	28/8/2015	Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus	Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies	Systemic Lupus Erythematosus	Drug: Tofacitinib;Drug: Placebo	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NULL	Completed	18 Years	100 Years	All	34	Phase 1	United States
210	EUCTR2014-004632-19-LT (EUCTR)	20/08/2015	19/06/2015	A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	360	Phase 3	United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;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
211	EUCTR2015-000372-95-CZ (EUCTR)	20/08/2015	16/06/2015	Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus	A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY	Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 150 mg/mL INN or Proposed INN: vobarilizumab Other descriptive name: IL-6R nanobody	Ablynx N.V.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of
212	EUCTR2015-000372-95-ES (EUCTR)	07/08/2015	10/07/2015	Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus	A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY	Moderate to Severe Active Systemic Lupus Erythematosus MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 150 mg/mL INN or Proposed INN: N/A Other descriptive name: IL-6R nanobody	Ablynx N.V.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	Germany;Korea, Republic of;Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru
213	EUCTR2014-004633-96-GB (EUCTR)	16/07/2015	08/05/2015	A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		AstraZeneca AB	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of
214	NCT02446899 (ClinicalTrials.gov)	July 9, 2015	14/5/2015	Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Biological: Anifrolumab;Drug: Placebo	AstraZeneca	PRA Health Sciences	Completed	18 Years	70 Years	All	373	Phase 3	United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore
215	NCT02533570 (ClinicalTrials.gov)	July 2015	9/7/2015	Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus	A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Brentuximab vedotin;Drug: Placebo	Seagen Inc.	NULL	Terminated	18 Years	N/A	All	20	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
216	NCT02437890 (ClinicalTrials.gov)	July 2015	29/4/2015	A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus	A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Biological: ALX-0061;Biological: Placebo	Ablynx	NULL	Completed	18 Years	64 Years	All	312	Phase 2	United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic
217	EUCTR2014-005000-19-DE (EUCTR)	17/06/2015	12/02/2015	A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® 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 N.V.	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 2	United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany
218	NCT02446912 (ClinicalTrials.gov)	June 9, 2015	14/5/2015	Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus	A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus	Biological: Anifrolumab;Drug: Placebo	AstraZeneca	PRA Health Sciences	Completed	18 Years	70 Years	All	460	Phase 3	United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom
219	EUCTR2014-002984-14-BG (EUCTR)	05/06/2015	11/05/2015	International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupus	A multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. -	Systemic lupus erythematosus ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: ACT-334441 Other descriptive name: ACT-334441	ACTELION Pharmaceuticals Ltd	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 2	Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria
220	NCT02472795 (ClinicalTrials.gov)	June 1, 2015	14/5/2015	Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Matching placebo;Drug: Cenerimod	Idorsia Pharmaceuticals Ltd.	NULL	Completed	18 Years	65 Years	All	105	Phase 1;Phase 2	United States;Belarus;Bulgaria;Georgia;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
221	NCT02465580 (ClinicalTrials.gov)	June 2015	3/6/2015	A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus	A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: hrIL-2 active;Drug: hrIL-2 placebo	Peking University People's Hospital	Monash University;Beijing SL Pharmaceutical Company Ltd	Recruiting	18 Years	65 Years	Both	60	Phase 2	China
222	EUCTR2014-005000-19-ES (EUCTR)	11/05/2015	03/03/2015	A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: STELARA ® 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 N.V.	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany
223	EUCTR2014-005000-19-HU (EUCTR)	18/03/2015	03/02/2015	A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus	A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Janssen-Cilag International N.V.	NULL	Not Recruiting			Female: yes Male: yes	134	Phase 2	United States;Taiwan;Hungary;Mexico;Argentina;Poland;Spain;Australia;Germany
224	NCT02504645 (ClinicalTrials.gov)	March 2015	17/7/2015	A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus	A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Drug: IPP-201101;Drug: Placebo;Other: Standard of Care	ImmuPharma	NULL	Completed	18 Years	70 Years	All	202	Phase 3	United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy
225	EUCTR2014-002184-14-DE (EUCTR)	26/02/2015	23/12/2014	Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 01 - Site Specific- dated-20-Aug-2014	Active Systemic Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: lulizumab pegol Product Code: BMS-931699 INN or Proposed INN: lulizumab pegol Other descriptive name: Anti-CD28dAb	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;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
226	EUCTR2014-002184-14-IT (EUCTR)	24/02/2015	09/01/2015	Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Lulizumab Pegol Other descriptive name: Lulizumab Pegol	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
227	EUCTR2014-002184-14-HU (EUCTR)	16/02/2015	29/12/2014	Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus ErythematosusPharmacogenetics Blood Sample Amendment 1 - Site Specific - dated-20-Aug-2014	Active Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of
228	NCT01845740 (ClinicalTrials.gov)	January 2015	17/4/2013	Phase Ib Study of SC Milatuzumab in SLE	A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)	Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus Nephritis	Drug: milatuzumab;Drug: Placebo	Immunomedics, Inc.	Department of Defense	Recruiting	18 Years	N/A	Both	30	Phase 1;Phase 2	United States
229	EUCTR2014-002184-14-ES (EUCTR)	26/12/2014	22/12/2014	Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus	Active Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	350	Phase 2	Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy
230	NCT02265744 (ClinicalTrials.gov)	November 13, 2014	15/10/2014	Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus	A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus	Lupus	Drug: BMS-931699;Drug: Placebo matching BMS-931699	Bristol-Myers Squibb	NULL	Completed	18 Years	70 Years	All	730	Phase 2	United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar
No.	TrialID	Date_ enrollment	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	NCT02321709 (ClinicalTrials.gov)	November 2014	5/12/2014	Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients	A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patients	Systemic Lupus Erythematosus	Drug: SAR113244;Drug: placebo	Sanofi	NULL	Completed	18 Years	75 Years	Both	21	Phase 1	Germany
232	NCT02185040 (ClinicalTrials.gov)	September 16, 2014	7/7/2014	A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.	A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: CC -220;Drug: Placebo	Celgene	NULL	Completed	18 Years	N/A	All	42	Phase 2	United States
233	NCT02194400 (ClinicalTrials.gov)	July 2014	16/7/2014	Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus	A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Biological: RSLV-132	Resolve Therapeutics	NULL	Completed	18 Years	70 Years	Both	32	Phase 1	United States
234	EUCTR2011-005667-25-PL (EUCTR)	22/05/2014	07/06/2013	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	4000	Phase 4	Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Norway;New Zealand
235	NCT01956188 (ClinicalTrials.gov)	May 2014	25/9/2013	Omega 3 in LES and APS	Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome	Systemic Lupus Erythematosus;Primary Antiphospholipid Syndrome	Dietary Supplement: EPA and DHA supplementation;Dietary Supplement: Placebo	University of Sao Paulo	NULL	Active, not recruiting	20 Years	45 Years	Female	22	N/A	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
236	NCT02106897 (ClinicalTrials.gov)	April 30, 2014	4/4/2014	Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus	A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus;Healthy Volunteers	Drug: BIIB059;Drug: Placebo	Biogen	NULL	Completed	18 Years	N/A	All	109	Phase 1	United States
237	EUCTR2013-002773-21-IT (EUCTR)	25/03/2014	03/02/2014	Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)	A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) - ADDRESS II	Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	279	Phase 2	United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
238	EUCTR2013-002773-21-GB (EUCTR)	03/03/2014	15/01/2014	Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)	A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	279	Phase 2	United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
239	EUCTR2013-002773-21-CZ (EUCTR)	20/02/2014	11/12/2013	Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)	A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	279	Phase 2	United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
240	EUCTR2013-002773-21-ES (EUCTR)	20/02/2014	22/01/2014	Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)	A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	279	Phase 2	United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;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
241	EUCTR2013-002773-21-DE (EUCTR)	17/02/2014	07/01/2014	Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)	A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT Product Name: Atacicept INN or Proposed INN: Atacicept Other descriptive name: ATACICEPT	Merck KGaA	NULL	Not Recruiting			Female: yes Male: yes	279	Phase 2	United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of
242	NCT02270957 (ClinicalTrials.gov)	January 2014	13/10/2014	Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches	Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study)	Systemic Lupus Erythematosus	Biological: Abatacept;Other: Placebo	Oklahoma Medical Research Foundation	Bristol-Myers Squibb	Active, not recruiting	18 Years	70 Years	All	66	Phase 2	United States
243	NCT01972568 (ClinicalTrials.gov)	December 2013	24/10/2013	Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus	A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)	Lupus Erythematosus, Systemic	Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo	EMD Serono	NULL	Completed	18 Years	N/A	All	306	Phase 2	United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine
244	EUCTR2011-005667-25-RO (EUCTR)	21/06/2013	21/07/2014	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5000		Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
245	EUCTR2011-005672-42-GB (EUCTR)	11/06/2013	27/03/2013	Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)	A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE	Systemic Lupus Erythematosus (SLE) MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	501	Phase 3;Phase 4	United States;France;Martinique;Brazil;South Africa;Colombia;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
246	EUCTR2011-005667-25-LT (EUCTR)	10/05/2013	29/11/2012	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	4000	Phase 4	Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
247	EUCTR2011-005667-25-BG (EUCTR)	24/04/2013	31/01/2013	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	4000	Phase 4	United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
248	EUCTR2011-005667-25-PT (EUCTR)	05/04/2013	17/01/2013	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	4000	Phase 4	Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand;United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada
249	NCT01863641 (ClinicalTrials.gov)	April 2013	17/5/2013	The Effect of Calcitriol on Progress and Activity of Lupus Nephritis	The Effect of Calcitriol on Progress and Activity of Lupus Nephritis	Systemic Lupus Erythematosus	Drug: calcitriol;Drug: placebo	Guilan University of Medical Sciences	NULL	Recruiting	18 Years	65 Years	Both	50	Phase 2	Iran, Islamic Republic of
250	EUCTR2011-005667-25-SK (EUCTR)	27/03/2013	05/02/2013	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	4000	Phase 4	Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;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
251	EUCTR2011-005667-25-IT (EUCTR)	21/03/2013	14/01/2013	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 15.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion INN or Proposed INN: BELIMUMAB	HUMAN GENOME SCIENCES INC	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5000		Portugal;United States;Philippines;Estonia;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Croatia;Bulgaria;New Zealand
252	NCT01777256 (ClinicalTrials.gov)	March 1, 2013	24/1/2013	An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184	An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: Placebo	GlaxoSmithKline	NULL	Terminated	18 Years	75 Years	All	51	Phase 2	Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic
253	NCT01632241 (ClinicalTrials.gov)	February 19, 2013	28/6/2012	Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)	A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	503	Phase 4	United States;Brazil;Colombia;France;South Africa;United Kingdom
254	EUCTR2011-005667-25-ES (EUCTR)	14/02/2013	21/12/2012	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5000		Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Norway;New Zealand
255	EUCTR2011-000368-88-IT (EUCTR)	04/02/2013	11/12/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age.	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE	Systemic lupus erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta (belimumab) INN or Proposed INN: BELIMUMAB	GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.	NULL	Not Recruiting			Female: yes Male: yes	100		United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;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
256	NCT01395745 (ClinicalTrials.gov)	February 2013	14/7/2011	CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus	A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: blisibimod;Drug: Placebo	Anthera Pharmaceuticals	NULL	Completed	18 Years	N/A	All	442	Phase 3	Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand
257	EUCTR2011-005667-25-CZ (EUCTR)	30/01/2013	04/12/2012	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5000	Phase 4	Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
258	EUCTR2011-005667-25-HU (EUCTR)	22/01/2013	22/11/2012	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion Product Name: Belimumab Product Code: L04AA26 INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	5000		Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
259	EUCTR2011-005667-25-EE (EUCTR)	08/01/2013	12/12/2012	Belimumab Assessment of Safety in SLE (BASE)	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Lupus Erythematosus MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	4000	Phase 4	Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
260	NCT01764594 (ClinicalTrials.gov)	January 2013	2/1/2013	Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus	A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus	Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease	Biological: CDP7657;Other: Placebo	UCB Pharma	Biogen	Completed	18 Years	75 Years	Both	24	Phase 1	Belgium;Bulgaria;Germany;Poland;Romania;Russian Federation;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
261	NCT01753401 (ClinicalTrials.gov)	January 2013	17/12/2012	Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease	A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease	Systemic Lupus Erythematosus (SLE)	Drug: Acthar;Drug: Placebo;Drug: Steroid Drug	Mallinckrodt	NULL	Completed	18 Years	N/A	All	38	Phase 4	United States
262	EUCTR2011-000368-88-NL (EUCTR)	03/12/2012	02/07/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom
263	NCT01705977 (ClinicalTrials.gov)	November 27, 2012	10/10/2012	Belimumab Assessment of Safety in SLE	A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab	Systemic Lupus Erythematosus	Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapy	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Active, not recruiting	18 Years	N/A	All	4019	Phase 4	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway
264	NCT01686555 (ClinicalTrials.gov)	November 2012	13/9/2012	A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)	Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)	Lupus Erythematosus	Drug: ABT-199;Other: Placebo	AbbVie (prior sponsor, Abbott)	NULL	Completed	18 Years	65 Years	Female	97	Phase 1	United States;Germany;Mexico;Puerto Rico
265	NCT01649765 (ClinicalTrials.gov)	September 7, 2012	23/7/2012	Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: belimumab 10mg/kg;Other: placebo	GlaxoSmithKline	Human Genome Sciences Inc., a GSK Company	Active, not recruiting	5 Years	17 Years	All	93	Phase 2	United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;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
266	NCT01689025 (ClinicalTrials.gov)	September 2012	14/9/2012	An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)	A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus	Inflammation;Systemic Lupus Erythematosus	Drug: NNC0114-0006;Drug: placebo	Novo Nordisk A/S	NULL	Terminated	18 Years	64 Years	Both	10	Phase 1	United States;Hungary;Poland;Serbia
267	EUCTR2011-004296-36-CZ (EUCTR)	29/08/2012	28/06/2012	A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus Erythematosus	A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus	Systemic Lupus Erythematosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: MEDI-546 Product Code: MEDI-546 INN or Proposed INN: MEDI-546	MedImmune, LLC	,NULL	Not Recruiting			Female: yes Male: yes	300	Phase 2	United States;Taiwan;Hong Kong;Ukraine;Israel;Colombia;India;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of
268	NCT01597050 (ClinicalTrials.gov)	August 2012	9/5/2012	Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions	A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions	Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic	Drug: R932333;Drug: Placebo	Rigel Pharmaceuticals	NULL	Completed	18 Years	75 Years	All	54	Phase 2	United States;Canada
269	EUCTR2011-000368-88-ES (EUCTR)	27/07/2012	21/05/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age.	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA? (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline, S.A.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100		Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland
270	NCT01892748 (ClinicalTrials.gov)	July 2012	17/6/2013	Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.	Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.	Systemic Lupus Erythematosus	Drug: Cholecalciferol;Drug: Placebo	ROSA MARIA RODRIGUES PEREIRA	NULL	Completed	10 Years	25 Years	Female	60	N/A	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
271	EUCTR2011-000420-15-DE (EUCTR)	21/06/2012	06/12/2011	STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly	SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: PF-04236921 INN or Proposed INN: Not applicable	Pfizer Inc.235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180		United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of
272	EUCTR2011-000368-88-GB (EUCTR)	13/06/2012	18/04/2012	A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age	A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE) - Belimumab in pediatric patients with SLE	Systemic Lupus Erythematosus MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: BENLYSTA™ (belimumab) Product Name: Benlysta (belimumab) Product Code: GSK1550188 INN or Proposed INN: belimumab	GlaxoSmithKline Research & Development Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	100	Phase 2	United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom
273	EUCTR2011-003814-18-PL (EUCTR)	06/06/2012	19/06/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
274	EUCTR2011-003814-18-PT (EUCTR)	01/06/2012	21/02/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
275	NCT01683695 (ClinicalTrials.gov)	June 2012	14/3/2012	Safety Study of AMG 557 in Subjects With Lupus Arthritis	A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis	Lupus Arthritis, Systemic Lupus Erythematosus	Drug: AMG 557;Drug: Matching Placebo	Amgen	NULL	Completed	18 Years	65 Years	All	20	Phase 1	United States;Australia;Denmark;France;Germany;Malaysia;Taiwan;United Kingdom;Singapore
No.	TrialID	Date_ enrollment	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	EUCTR2010-023396-25-PL (EUCTR)	30/05/2012	23/09/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE	Systemic lupus erythematosus (SLE) MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2a	France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
277	EUCTR2011-003814-18-BE (EUCTR)	29/05/2012	01/02/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
278	EUCTR2011-003814-18-BG (EUCTR)	22/05/2012	21/05/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
279	EUCTR2011-003814-18-IT (EUCTR)	15/05/2012	08/06/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab Product Code: NA INN or Proposed INN: BELIMUMAB Other descriptive name: Benlysta	HUMAN GENOME SCIENCES INC	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden
280	EUCTR2011-003814-18-DE (EUCTR)	03/05/2012	16/12/2011	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;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
281	EUCTR2011-003814-18-ES (EUCTR)	03/05/2012	29/02/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
282	NCT01687309 (ClinicalTrials.gov)	April 30, 2012	10/5/2012	A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender	A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects	Systemic Lupus Erythematosus	Drug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without food	GlaxoSmithKline	NULL	Completed	18 Years	65 Years	All	19	Phase 1	Belgium
283	EUCTR2011-003814-18-GB (EUCTR)	12/04/2012	19/04/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
284	EUCTR2010-018563-41-EE (EUCTR)	09/04/2012	09/03/2012	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
285	EUCTR2011-003814-18-SE (EUCTR)	28/03/2012	31/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;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
286	EUCTR2011-003814-18-CZ (EUCTR)	27/03/2012	25/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
287	EUCTR2010-018563-41-LT (EUCTR)	14/03/2012	14/02/2012	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
288	EUCTR2011-003814-18-DK (EUCTR)	08/03/2012	08/03/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
289	EUCTR2011-003814-18-HU (EUCTR)	08/03/2012	18/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
290	NCT01551069 (ClinicalTrials.gov)	March 2012	8/3/2012	Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion	A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion	Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus	Drug: hydroxychloroquine (Z0188);Drug: Placebo	Sanofi	NULL	Completed	18 Years	N/A	Both	103	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
291	EUCTR2010-023396-25-NL (EUCTR)	16/02/2012	24/10/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2a	France;Czech Republic;Belgium;Spain;Poland;Australia;Germany;Netherlands;Italy;United Kingdom
292	EUCTR2011-000420-15-HU (EUCTR)	08/02/2012	15/12/2011	STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)	A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly	SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Not applicable Product Code: PF-04236921 INN or Proposed INN: Not applicable	Pfizer Inc.235 East 42nd Street, New York, NY 10017	NULL	Not Recruiting			Female: yes Male: yes	180		United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of
293	EUCTR2011-003814-18-AT (EUCTR)	01/02/2012	23/01/2012	A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC	Systemic lupus erythematosis (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Belimumab INN or Proposed INN: Belimumab Other descriptive name: Benlysta	Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)	NULL	Not Recruiting			Female: yes Male: yes	816	Phase 3	United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
294	NCT01440231 (ClinicalTrials.gov)	February 2012	22/9/2011	Atacicept Demonstrating Dose RESponSe	A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: Placebo;Drug: Atacicept	EMD Serono	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 2	United States
295	NCT01488708 (ClinicalTrials.gov)	January 2012	6/12/2011	On Open-Label Study in Participants With Systemic Lupus Erythematosus	A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)	Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease	Drug: LY2127399;Drug: Placebo	Eli Lilly and Company	NULL	Terminated	18 Years	N/A	All	1518	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
296	NCT01438489 (ClinicalTrials.gov)	January 2012	9/9/2011	A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus	A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo	MedImmune LLC	NULL	Completed	18 Years	65 Years	All	626	Phase 2	United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong
297	NCT01405196 (ClinicalTrials.gov)	December 2011	27/7/2011	Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus	A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)	Lupus Erythematosus, Systemic	Biological: PF-04236921	Pfizer	NULL	Completed	18 Years	75 Years	All	183	Phase 2	United States;Argentina;Chile;Colombia;Germany;Hungary;Korea, Republic of;Moldova, Republic of;Peru;Poland;Puerto Rico;Romania;Taiwan;Mexico
298	NCT01484496 (ClinicalTrials.gov)	November 16, 2011	28/11/2011	A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	All	839	Phase 3	United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic
299	EUCTR2010-023396-25-DE (EUCTR)	09/11/2011	14/06/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2a	France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
300	EUCTR2010-023396-25-CZ (EUCTR)	13/10/2011	01/08/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2a	France;Czech Republic;Belgium;Spain;Poland;Australia;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
301	NCT01449071 (ClinicalTrials.gov)	October 2011	3/10/2011	Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)	A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease	Systemic Lupus Erythematosus	Biological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mg	UCB Pharma	NULL	Completed	18 Years	64 Years	Both	20	Phase 1;Phase 2	Japan
302	EUCTR2010-023396-25-GB (EUCTR)	22/09/2011	11/04/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE	Systemic lupus erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 INN or Proposed INN: . Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom
303	EUCTR2010-023396-25-ES (EUCTR)	20/09/2011	11/11/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Ensayo clínico multicéntrico, de grupos paralelos, controlado por placebo, doble ciego, randomizado 2:2:1, de fase IIa, para investigar la seguridad, eficacia y farmacocinética del receptor Fc-gamma IIb recombinante, humano, soluble (SM101) para su aplicación intravenosa en el tratamiento de pacientes con lupus eritematoso sistémico (LES) con o sin un historial de nefritis lúpica - SMILE	lupus eritematoso sistémico (LES) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50		Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Poland;Australia
304	EUCTR2010-018565-26-IT (EUCTR)	15/09/2011	05/01/2012	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2	Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India
305	EUCTR2010-018563-41-BG (EUCTR)	02/09/2011	25/07/2011	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;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
306	EUCTR2010-023396-25-BE (EUCTR)	13/07/2011	20/04/2011	A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)	Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE	Systemic lupus erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: soluble Fc-gamma receptor IIb Product Code: SM101 Other descriptive name: soluble Fc receptor	SuppreMol GmbH	NULL	Not Recruiting			Female: yes Male: yes	50	Phase 2	France;Czech Republic;Spain;Poland;Belgium;Australia;Netherlands;Germany;Italy;United Kingdom
307	EUCTR2010-022099-29-DE (EUCTR)	04/07/2011	14/12/2010	Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1	Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Canada;Macedonia, the former Yugoslav Republic of;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
308	EUCTR2010-018563-41-IT (EUCTR)	23/06/2011	20/03/2012	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: EPRATUZUMAB	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
309	EUCTR2010-018565-26-DE (EUCTR)	21/06/2011	21/01/2011	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2	Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
310	EUCTR2010-018563-41-DE (EUCTR)	21/06/2011	21/01/2011	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;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
311	EUCTR2010-022099-29-BG (EUCTR)	16/06/2011	24/02/2011	Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1	Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	United States;Belarus;Philippines;Thailand;Guatemala;Ukraine;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
312	EUCTR2010-018563-41-BE (EUCTR)	25/05/2011	19/11/2010	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Belgium;Brazil;Australia;Bulgaria;Germany;Korea, Republic of
313	NCT01345253 (ClinicalTrials.gov)	May 23, 2011	28/4/2011	GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia	GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia	Systemic Lupus Erythematosus	Drug: Belimumab;Drug: Placebo	GlaxoSmithKline	Human Genome Sciences Inc.	Completed	18 Years	N/A	All	709	Phase 3	China;Japan;Korea, Republic of
314	EUCTR2010-018565-26-GB (EUCTR)	13/05/2011	09/02/2011	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2	Systemic Lupus Erythmatosus MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;Italy;United Kingdom;India
315	EUCTR2010-018563-41-GB (EUCTR)	13/05/2011	09/02/2011	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;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
316	NCT01858792 (ClinicalTrials.gov)	May 2011	19/12/2012	A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies	Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies	Lupus Erythematosus, Discoid	Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo	Human Genome Sciences Inc., a GSK Company	GlaxoSmithKline	Completed	18 Years	N/A	Both	1	N/A	NULL
317	EUCTR2010-022100-42-GB (EUCTR)	28/04/2011	19/01/2011	Not available	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - (ILLUMINATE-2)	Systemic Lupus Erythematosus (SLE) MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	United States;Serbia;Taiwan;Ecuador;Spain;Russian Federation;Israel;United Kingdom;India;France;Hungary;Mexico;Canada;Brazil;Malaysia;Romania;Australia;South Africa;Tunisia;Latvia;New Zealand
318	EUCTR2010-022100-42-ES (EUCTR)	20/04/2011	15/02/2011	Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE)	Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE)	Lupus Eritematoso Sistémico (LES) //Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: Anti LP40 anticuerpo, subclase IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	Hungary;Spain;Latvia;United Kingdom
319	EUCTR2010-022100-42-LV (EUCTR)	08/04/2011	13/01/2011	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2	Systemic Lupus Erythematosus (SLE) MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand
320	NCT01283139 (ClinicalTrials.gov)	March 31, 2011	20/1/2011	A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus	A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Biological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: Placebo	MedImmune LLC	NULL	Completed	18 Years	75 Years	All	834	Phase 2	United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;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
321	EUCTR2010-018563-41-CZ (EUCTR)	25/02/2011	26/01/2011	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1	Systemic Lupus Erythmatosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of
322	EUCTR2010-022100-42-HU (EUCTR)	23/02/2011	13/01/2011	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2	Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand
323	EUCTR2010-018565-26-ES (EUCTR)	22/02/2011	23/12/2010	Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2	Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2	Lupus Sistémico Eritematoso MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780		Hungary;Spain;Germany;Italy;United Kingdom
324	EUCTR2010-018563-41-ES (EUCTR)	21/02/2011	22/12/2010	Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1	Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1	Lupus eritematoso sistémico MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Estonia;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
325	EUCTR2010-022099-29-AT (EUCTR)	27/01/2011	28/12/2010	Study investigating a new medicine, LY2127399, in patients diagnosedwith Systemic Lupus Erythematosus (SLE).	A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1	Systemic Lupus Erythematosus (SLE) MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: LY2127399 Product Code: LY2127399 Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4	Eli Lilly and Company	NULL	Not Recruiting			Female: yes Male: yes	1140	Phase 3	United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;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
326	EUCTR2010-018565-26-HU (EUCTR)	16/01/2011	22/11/2010	Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)	A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 2) - EMBODY 2	Systemic Lupus Erythmatosus MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Product Name: Epratuzumab Product Code: CDP3194 INN or Proposed INN: Epratuzumab	UCB Inc.	NULL	Not Recruiting			Female: yes Male: yes	780	Phase 3	Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India
327	NCT01217320 (ClinicalTrials.gov)	January 2011	6/10/2010	Creatine Supplementation in Pediatric Rheumatology	Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis	Juvenile Systemic Lupus Erythematosus;Juvenile Dermatomyositis	Dietary Supplement: creatine;Dietary Supplement: placebo (dextrose)	University of Sao Paulo	NULL	Recruiting	6 Years	18 Years	Both	40	N/A	Brazil
328	NCT01205438 (ClinicalTrials.gov)	January 2011	17/9/2010	A Study of LY2127399 in Participants With Systemic Lupus Erythematosus	A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease	Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks	Eli Lilly and Company	NULL	Completed	18 Years	N/A	All	1124	Phase 3	United States;Australia;Brazil;Canada;Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom
329	NCT01276782 (ClinicalTrials.gov)	January 2011	12/1/2011	Levothyroxine in Pregnant SLE Patients	Pilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid Disease	Systemic Lupus Erythematosus	Drug: Levothyroxine	Johns Hopkins University	New York University School of Medicine;Duke University;University of Chicago;Stanford University	Withdrawn	18 Years	45 Years	Female	0	Phase 4	United States
330	NCT01262365 (ClinicalTrials.gov)	December 2010	14/12/2010	Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease	Systemic Lupus Erythematosus	Drug: Epratuzumab;Drug: Placebo	UCB Pharma	NULL	Completed	18 Years	N/A	All	793	Phase 3	United States;Australia;Belgium;Brazil;Bulgaria;Czechia;Estonia;France;Germany;India;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;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
331	NCT01261793 (ClinicalTrials.gov)	December 2010	14/12/2010	Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)	A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease	Systemic Lupus Erythematosus	Drug: Placebo;Drug: Epratuzumab	UCB Pharma	NULL	Completed	18 Years	N/A	All	791	Phase 3	United States;Brazil;Canada;France;Germany;Hungary;India;Italy;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Netherlands
332	NCT01196091 (ClinicalTrials.gov)	December 2010	3/9/2010	A Study of LY2127399 in Participants With Systemic Lupus Erythematosus	A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease	Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks;Drug: Standard of Care	Eli Lilly and Company	NULL	Completed	18 Years	N/A	All	1164	Phase 3	United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey
333	EUCTR2010-018383-16-BE (EUCTR)	10/11/2010	19/07/2010	A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany
334	EUCTR2010-018383-16-PT (EUCTR)	01/10/2010	23/07/2010	A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220		France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
335	EUCTR2010-018383-16-DE (EUCTR)	17/09/2010	16/07/2010	A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220		United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;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
336	EUCTR2010-018383-16-HU (EUCTR)	16/08/2010	20/07/2010	A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220		Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland
337	EUCTR2010-018383-16-CZ (EUCTR)	13/08/2010	22/07/2010	A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: Forigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Not Recruiting			Female: yes Male: yes	220		France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany
338	EUCTR2009-012059-47-DE (EUCTR)	12/08/2010	21/01/2010	A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 12.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 1;Phase 2	France;Belgium;Bulgaria;Germany
339	EUCTR2010-018383-16-ES (EUCTR)	10/08/2010	20/07/2010	Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220		Portugal;Hungary;Czech Republic;Germany;France;Spain
340	EUCTR2010-018383-16-FR (EUCTR)	05/08/2010	29/07/2010	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47	Patients With Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Lupuzor Product Code: CEP-33457 INN or Proposed INN: rigerimod Other descriptive name: IPP-201101, P140	Cephalon, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220		Portugal;Hungary;Czech Republic;Germany;France;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
341	NCT01164917 (ClinicalTrials.gov)	August 2010	15/7/2010	Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus	A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus	Cutaneous Lupus;Discoid Lupus;Lupus;Systemic Lupus Erythematosus	Drug: AMG811;Drug: AMG811 Placebo	Amgen	NULL	Terminated	18 Years	70 Years	Both	16	Phase 1	United States
342	NCT01381536 (ClinicalTrials.gov)	July 20, 2010	21/4/2011	Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)	GSK1550188, A Randomised, Single-blind, Placebo Controlled, Dose Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus	Drug: GSK1550188 1mg/kg or 10mg/kg	GlaxoSmithKline	NULL	Completed	20 Years	N/A	All	12	Phase 1	Japan
343	NCT01085084 (ClinicalTrials.gov)	July 2010	9/3/2010	Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis	A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis	Lupus Arthritis	Drug: Laquinimod;Other: Placebo	Teva Pharmaceutical Industries	NULL	Completed	18 Years	75 Years	Both	82	Phase 2	United States;Canada
344	NCT01162681 (ClinicalTrials.gov)	July 2010	13/7/2010	PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus	A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: A-623;Other: Placebo Comparator	Anthera Pharmaceuticals	NULL	Completed	18 Years	N/A	Both	547	Phase 2	United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan
345	NCT01085097 (ClinicalTrials.gov)	July 2010	4/3/2010	Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Nephritis	A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)	Lupus Nephritis	Drug: laquinimod;Drug: Mycophenolate Mofetil;Drug: prednisolone /prednisone;Drug: Placebo	Teva Pharmaceutical Industries	NULL	Completed	18 Years	75 Years	Both	47	Phase 2	United States;Canada;France;Russian Federation;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
346	NCT01170585 (ClinicalTrials.gov)	July 2010	26/7/2010	A Trial of Rosuvastatin in Systemic Lupus Erythematosus	A Randomised Placebo Controlled Trial of Rosuvastatin in Systemic Lupus Erythematosus	Atherosclerosis;Systemic Lupus Erythematosus	Drug: Rosuvastatin;Drug: Placebo	Imperial College London	NULL	Completed	18 Years	80 Years	Both	33	Phase 2	United Kingdom
347	NCT01135459 (ClinicalTrials.gov)	June 2010	1/6/2010	A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus Erythematosus	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Lupuzor;Drug: Placebo	Cephalon	NULL	Completed	18 Years	70 Years	Both	183	Phase 2	United States;Belgium;Czech Republic;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom
348	EUCTR2009-012059-47-FR (EUCTR)	07/05/2010	02/02/2010	A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 12.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus		Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 1;Phase 2	France;Belgium;Bulgaria;Germany
349	NCT01127321 (ClinicalTrials.gov)	May 2010	14/4/2010	A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus	A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE	Lupus Erythematosus, Systemic	Other: Placebo;Biological: MEDI-570 0.03 MG;Biological: MEDI-570 0.1 MG;Biological: MEDI-570 0.3 MG;Biological: MEDI-570 1 MG	MedImmune LLC	AstraZeneca	Terminated	18 Years	N/A	All	44	Phase 1	United States;Canada;Mexico;Peru;South Africa
350	EUCTR2009-012059-47-BG (EUCTR)	23/04/2010	15/04/2010	A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus.	A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 1;Phase 2	France;Belgium;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
351	NCT01425775 (ClinicalTrials.gov)	April 2010	18/8/2011	The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)		Systemic Lupus Erythematosus	Drug: vitamin D 25(OH)D;Other: Placebo	Faculty of Medicine, University of Alexandria	NULL	Completed	18 Years	60 Years	Both	248	N/A	Egypt
352	NCT01058343 (ClinicalTrials.gov)	March 2010	27/1/2010	Safety of IFNa Kinoid in Systemic Lupus Erythematosus	A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.	Systemic Lupus Erythematosus	Biological: IFN-K	Neovacs	NULL	Completed	18 Years	50 Years	All	28	Phase 1;Phase 2	Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain
353	NCT01093911 (ClinicalTrials.gov)	March 2010	12/3/2010	Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)	A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.	Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease	Biological: CDP7657;Other: Placebo	UCB Pharma	NULL	Completed	18 Years	60 Years	Both	44	Phase 1	Belgium;Bulgaria;Germany
354	EUCTR2006-006214-16-GB (EUCTR)	23/02/2010	29/02/2008	A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE	A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE	Systemic lupus erythematosus. MedDRA version: 13.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders		Imperial College	NULL	Not Recruiting			Female: yes Male: yes	64	Phase 4	United Kingdom
355	EUCTR2009-012059-47-BE (EUCTR)	28/01/2010	05/01/2010	A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE) MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: IFN-a2b Kinoid Product Code: IFN-K INN or Proposed INN: Not assigned yet Other descriptive name: IFN-a 2b Kinoid Drug Substance	Neovacs SA	NULL	Not Recruiting			Female: yes Male: yes	28	Phase 1;Phase 2	France;Belgium;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
356	NCT01018238 (ClinicalTrials.gov)	November 2009	16/11/2009	An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)	A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)	Inflammation;Systemic Lupus Erythematosus	Drug: NNC 0151-0000-0000;Drug: placebo	Novo Nordisk A/S	NULL	Withdrawn	18 Years	65 Years	Both	0	Phase 1	United States
357	NCT00962832 (ClinicalTrials.gov)	September 2009	19/8/2009	A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Placebo;Drug: Rontalizumab	Genentech, Inc.	NULL	Completed	18 Years	65 Years	Both	238	Phase 2	United States;Argentina;Colombia;Mexico;Poland;Russian Federation;United Kingdom
358	NCT01914770 (ClinicalTrials.gov)	July 2009	3/4/2012	Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76	Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76	Systemic Lupus Erythematosus	Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: Placebo	GlaxoSmithKline	Human Genome Sciences Inc.	Completed	18 Years	N/A	Both	1016	N/A	NULL
359	NCT00960362 (ClinicalTrials.gov)	July 2009	14/8/2009	An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)	A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus	Inflammation;Systemic Lupus Erythematosus (SLE)	Drug: AGS-009;Drug: placebo	Argos Therapeutics	NULL	Completed	18 Years	65 Years	Both	13	Phase 1	United States;Sweden
360	NCT00976729 (ClinicalTrials.gov)	May 2009	11/9/2009	NOX-E36 First-in-Human (FIH) Study	NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects	Chronic Inflammatory Diseases;Type 2 Diabetes Mellitus;Systemic Lupus Erythematosus	Drug: NOX-E36;Drug: Placebo	NOXXON Pharma AG	NULL	Completed	18 Years	60 Years	Both	72	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
361	EUCTR2007-003621-24-AT (EUCTR)	30/03/2009	23/04/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
362	NCT00818948 (ClinicalTrials.gov)	March 2009	18/12/2008	Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis	A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis	Nephritis;Systemic Lupus Erythematosus	Drug: AMG 811	Amgen	NULL	Completed	18 Years	70 Years	Both	56	Phase 1	United States;France;Hong Kong;Malaysia;Mexico;Singapore
363	NCT00828178 (ClinicalTrials.gov)	February 2009	22/1/2009	Efficacy of Fish Oil in Lupus Patients	A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.	Systemic Lupus Erythematosus	Drug: Omega-3;Device: flow-mediated dilation of the brachial artery;Other: corn starch	Michelle Petri M.D.,MPH	NULL	Completed	18 Years	N/A	All	106	Phase 4	United States
364	EUCTR2007-003621-24-GB (EUCTR)	02/12/2008	14/07/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension		MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 2	France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
365	NCT00774943 (ClinicalTrials.gov)	December 2008	16/10/2008	A Study of AMG 557 in Adults With Systemic Lupus Erythematosus	A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: AMG 557	Amgen	NULL	Completed	18 Years	70 Years	Both	58	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
366	NCT00752999 (ClinicalTrials.gov)	November 2008	15/9/2008	Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus	A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease	Systemic Lupus Erythematosus	Drug: Fostamatinib Disodium (R935788);Drug: Placebo	Rigel Pharmaceuticals	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 2	NULL
367	NCT00710021 (ClinicalTrials.gov)	November 2008	1/7/2008	Vitamin D3 in Systemic Lupus Erythematosus	Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)	Systemic Lupus Erythematosus;SLE;Lupus	Drug: Vitamin D3;Drug: Vitamin D3 placebo	National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence	Completed	18 Years	N/A	All	57	Phase 2	United States
368	EUCTR2007-003698-13-BG (EUCTR)	29/09/2008	07/08/2008	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5 Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono International	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
369	EUCTR2007-003698-13-LV (EUCTR)	15/09/2008	19/06/2008	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania
370	EUCTR2007-003698-13-GR (EUCTR)	09/09/2008	29/10/2009	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;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
371	EUCTR2006-000674-73-BG (EUCTR)	14/08/2008	14/08/2008	A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease	A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease	Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Abetimus Sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium Other descriptive name: RIQUENT	La Jolla Pharmaceutical Company	NULL	Not Recruiting			Female: yes Male: yes	730		Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
372	EUCTR2007-003621-24-NL (EUCTR)	23/07/2008	13/03/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
373	EUCTR2007-003621-24-IT (EUCTR)	15/07/2008	17/11/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil	MONDOGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
374	NCT00657189 (ClinicalTrials.gov)	July 2008	9/4/2008	A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus	A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic;Lupus	Drug: MEDI-545;Drug: Placebo	MedImmune LLC	NULL	Completed	18 Years	N/A	Both	87	Phase 2	United States
375	EUCTR2007-003621-24-BE (EUCTR)	20/06/2008	08/01/2008	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		France;Spain;Belgium;Austria;Germany;Netherlands;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
376	EUCTR2006-005357-29-BG (EUCTR)	18/06/2008	17/04/2008	Clinical trial to study a drug in people with kidney disease related to lupus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG	Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis MedDRA version: 15.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	369		Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
377	EUCTR2007-002566-35-HU (EUCTR)	09/06/2008	28/01/2008	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2b	Hungary;United Kingdom;Belgium;Spain;Lithuania
378	NCT02151409 (ClinicalTrials.gov)	June 2008	28/5/2014	Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects	A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.	Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy	Drug: NNC 0151-0000-0000;Drug: placebo	Novo Nordisk A/S	NULL	Completed	18 Years	55 Years	Male	60	Phase 1	Netherlands
379	EUCTR2007-003621-24-FR (EUCTR)	29/05/2008	27/12/2007	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	48		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
380	EUCTR2007-003698-13-LT (EUCTR)	14/05/2008	13/03/2008	Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;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
381	EUCTR2006-000674-73-IT (EUCTR)	12/05/2008	20/03/2008	A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND	A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND	Systemic lupus erithematosus (SLE) patients with a history of renal disease. MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus	LA JOLLA PHARMACEUTICAL COMPANY	NULL	Not Recruiting			Female: yes Male: yes	730		Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
382	EUCTR2007-003698-13-ES (EUCTR)	09/05/2008	12/02/2008	Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Lupus Eritematoso Sistémico Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	510	Phase 2;Phase 3	Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania
383	EUCTR2006-005355-16-GB (EUCTR)	07/05/2008	16/08/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	423		Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
384	EUCTR2006-005357-29-GB (EUCTR)	07/05/2008	16/08/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	Lupus Nephritis		F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	369	Phase 3	Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
385	NCT00611663 (ClinicalTrials.gov)	May 2008	28/1/2008	Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus	VACCILUP A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus	Lupus Erythematosus, Systemic	Biological: Prevenar® and Pneumo23®;Biological: Placebo, Pneumo23®	Assistance Publique - Hôpitaux de Paris	NULL	Completed	18 Years	65 Years	Both	47	Phase 2;Phase 3	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
386	EUCTR2007-003698-13-AT (EUCTR)	30/04/2008	10/03/2008	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono SA - Geneva	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom
387	EUCTR2007-004892-21-BG (EUCTR)	16/04/2008	15/04/2008	A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE)	A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE)	Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes)	Product Code: IPP-201101 INN or Proposed INN: IPP - 201101 Other descriptive name: P 140	IMMUPHARMA SA	NULL	Not Recruiting			Female: yes Male: yes	296	Phase 2b	Bulgaria;Spain
388	EUCTR2006-005355-16-SE (EUCTR)	10/04/2008	21/12/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	423		Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
389	EUCTR2007-003698-13-CZ (EUCTR)	09/04/2008	06/02/2008	Atacicept phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;India;France;Malaysia;Australia;Peru;Netherlands;Latvia;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
390	EUCTR2006-005355-16-PL (EUCTR)	04/04/2008	03/01/2008	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	423		Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;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
391	EUCTR2007-003698-13-NL (EUCTR)	01/04/2008	08/01/2008	Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
392	EUCTR2006-005355-16-DE (EUCTR)	25/03/2008	01/10/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	423		Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Poland;Sweden
393	EUCTR2007-003621-24-DE (EUCTR)	20/03/2008	13/02/2009	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.	Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension	Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP	MondoGEN AG	NULL	Not Recruiting			Female: yes Male: yes	48		United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria
394	EUCTR2007-002566-35-GB (EUCTR)	19/03/2008	29/11/2007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2b	Hungary;United Kingdom;Belgium;Spain;Lithuania
395	EUCTR2005-004575-37-GB (EUCTR)	14/03/2008	08/10/2008	A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).	A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).	IMMUNOSUPPRESSION FOR DISEASE, NOS MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic	Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Trade Name: CellCept Product Name: mycophenolate mofetil INN or Proposed INN: mycophenolate mofetil Other descriptive name: CellCept	Bristol-Myers Squibb International Corporation	NULL	Not Recruiting			Female: yes Male: yes	460	Phase 2;Phase 3	France;Belgium;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
396	EUCTR2006-005355-16-PT (EUCTR)	07/03/2008	23/11/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	423		Hungary;Portugal;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
397	EUCTR2006-005357-29-PT (EUCTR)	07/03/2008	23/11/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	Lupus Nephritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	369		Hungary;Portugal;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden
398	EUCTR2007-003698-13-GB (EUCTR)	06/03/2008	13/12/2007	Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Not Recruiting			Female: yes Male: yes	510	Phase 2;Phase 3	United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany
399	EUCTR2007-003698-13-FR (EUCTR)	04/03/2008	28/01/2008	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III	Systemic Lupus Erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Atacicept Product Code: TACI-Fc5 INN or Proposed INN: Atacicept Other descriptive name: TACI-Fc5	Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	510	Phase 2;Phase 3	Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania
400	EUCTR2007-002566-35-BE (EUCTR)	25/02/2008	03/12/2007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2b	Hungary;United Kingdom;Belgium;Spain;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
401	EUCTR2006-005355-16-NL (EUCTR)	22/02/2008	22/11/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus (SLE)	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	423		Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden
402	EUCTR2006-005357-29-NL (EUCTR)	22/02/2008	22/11/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	Lupus Nephritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	369		Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden
403	EUCTR2006-000674-73-ES (EUCTR)	21/02/2008	03/12/2007	ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA	ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA	Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium	La Jolla Pharmaceutical Company	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	730		Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
404	EUCTR2007-002566-35-ES (EUCTR)	14/02/2008	20/12/2007	Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	Lupus eritematoso sistémicosystemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2	UCB Inc	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	210	Phase 2b	Hungary;United Kingdom;Belgium;Spain;Lithuania
405	EUCTR2007-002566-35-LT (EUCTR)	11/02/2008	04/12/2007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007	systemic lupus erythematosus MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: epratuzumab Product Code: CDP3194 INN or Proposed INN: epratuzumab Other descriptive name: hLL2	UCB Inc	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 2b	Hungary;United Kingdom;Belgium;Spain;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
406	NCT00626197 (ClinicalTrials.gov)	February 2008	20/2/2008	A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus	Lupus Nephritis;Systemic Lupus Erythematosus	Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo	Genentech, Inc.	Roche Pharma AG	Completed	16 Years	N/A	All	381	Phase 3	United States
407	EUCTR2006-005357-29-DE (EUCTR)	31/01/2008	01/10/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG	Lupus Nephritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	369		Portugal;Hungary;United Kingdom;Germany;Netherlands;Bulgaria;France;Spain;Sweden
408	EUCTR2006-005357-29-SE (EUCTR)	30/01/2008	21/12/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	Lupus Nephritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	369		Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden
409	EUCTR2006-000674-73-DE (EUCTR)	23/01/2008	16/10/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE	Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium	La Jolla Pharmaceutical Company	NULL	Not Recruiting			Female: yes Male: yes	850		Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy
410	EUCTR2006-000674-73-PT (EUCTR)	11/01/2008	17/09/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE	Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium	La Jolla Pharmaceutical Company	NULL	Not Recruiting			Female: yes Male: yes	730		Portugal;Czech Republic;Hungary;Spain;Bulgaria;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
411	EUCTR2006-000674-73-CZ (EUCTR)	07/01/2008	25/10/2007	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE	Systemic lupus erythematosus patients with a history of renal disease MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: Abetimus sodium Product Code: LJP 394 INN or Proposed INN: Abetimus Sodium	La Jolla Pharmaceutical Company	NULL	Not Recruiting			Female: yes Male: yes	730		Portugal;Hungary;Germany;Czech Republic;Bulgaria;Spain;Italy
412	NCT00624338 (ClinicalTrials.gov)	January 2008	15/2/2008	Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)	A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)	Lupus Erythematosus, Systemic	Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo Comparator	EMD Serono	Merck KGaA	Completed	16 Years	N/A	All	461	Phase 2;Phase 3	United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom
413	NCT00624351 (ClinicalTrials.gov)	January 2008	15/2/2008	Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease	A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease	Systemic Lupus Erythematosus	Biological: Epratuzumab;Other: Placebo	UCB Pharma	NULL	Completed	18 Years	N/A	Both	227	Phase 2	United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom
414	NCT00539838 (ClinicalTrials.gov)	December 19, 2007	3/10/2007	A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo	Genentech, Inc.	Roche Pharma AG	Terminated	16 Years	N/A	All	33	Phase 3	United States
415	EUCTR2006-005177-21-AT (EUCTR)	06/12/2007	26/02/2007	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-76	Systemic Lupus Erythematosus (SLE) MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus	Product Name: belimumab Product Code: HGS1006 INN or Proposed INN: belimumab Other descriptive name: LymphoStat-B TM	Human Genome Sciences, Inc.	NULL	Not Recruiting			Female: yes Male: yes	810	Phase 3	Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;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
416	NCT02291588 (ClinicalTrials.gov)	December 2007	3/11/2014	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus	A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: AMG 811;Drug: Placebo	Amgen	NULL	Completed	18 Years	65 Years	Both	26	Phase 1	NULL
417	EUCTR2006-005357-29-HU (EUCTR)	21/11/2007	18/10/2007	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus	Lupus Nephritis	Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	369		Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;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

NCT04647708
(ClinicalTrials.gov)

December 2, 2020

23/11/2020

Study of M5049 in Cutaneous Lupus Erythematosus (CLE) and Systemic Lupus Erythematosus (SLE) Participants

A Phase Ib, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Multiple Ascending Doses of M5049 Administered Orally in Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus Participants Treated With Standard of Care

Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus

Drug: M5049;Drug: Placebo

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not yet recruiting

18 Years

65 Years

All

Phase 1

Bulgaria;Germany;Moldova, Republic of;Ukraine

NCT04643067
(ClinicalTrials.gov)

December 1, 2020

12/11/2020

A Study to Assess the Safety and Tolerability, PK and Efficacy of KPG-818 in Mild to Moderate SLE Patients

A Phase 1b/2a Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of KPG-818 in Patients With Mild to Moderate Systemic Lupus Erythematosus

SLE; Drug

Drug: 0.15mg KPG-818 dose;Drug: 0.6mg KPG-818 dose;Drug: 2mg KPG-818 dose;Drug: Placebo

Kangpu Biopharmaceuticals, Ltd.

NULL

Not yet recruiting

18 Years

N/A

All

Phase 1;Phase 2

NULL

EUCTR2019-000638-20-BG
(EUCTR)

09/11/2020

14/08/2020

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: ELSUBRUTINIB
Other descriptive name: ABBV-105
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

325

Phase 2

United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Bulgaria;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of

EUCTR2019-003323-38-GB
(EUCTR)

06/11/2020

13/10/2020

A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE

Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not applicable
Other descriptive name: LY3471851

Eli Lilly & Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Australia;Germany;Japan;Korea, Republic of

EUCTR2019-003323-38-HU
(EUCTR)

04/11/2020

10/09/2020

A study to determinate the safety and efficacy of LY3471851 in Adult Patients with Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults with Systemic Lupus Erythematosus - ISLAND-SLE

Product Name: LY3471851
Product Code: LY3471851
INN or Proposed INN: Not applicable
Other descriptive name: LY3471851

Eli Lilly & Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

United States;Taiwan;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;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

NCT04515719
(ClinicalTrials.gov)

November 1, 2020

13/8/2020

Efficacy and Safety of Belimumab in SLE Patients

Efficacy and Safety of Belimumab for Prevention of Disease Flares in SLE Patients With Low Disease Activity

Systemic Lupus Erythematosus

Biological: Belimumab;Biological: Placebo

RenJi Hospital

NULL

Not yet recruiting

18 Years

70 Years

All

334

Phase 4

NULL

NCT04582136
(ClinicalTrials.gov)

November 2020

3/10/2020

Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus

Efficacy and Safety of Sirolimus in Patients With Active Systemic Lupus Erythematosus Despite Standard of Care: a Multi-center, Double Blinded, Randomized, Placebo-controlled, Phase 2 Trial

Systemic Lupus Erythematosus

Drug: Sirolimus;Drug: Placebo

Chinese SLE Treatment And Research Group

Beijing Municipal Science & Technology Commission;North China Pharmaceutical Group Corporation

Not yet recruiting

18 Years

65 Years

All

146

Phase 2

NULL

EUCTR2019-002205-22-FR
(EUCTR)

01/10/2020

13/01/2020

Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis.

SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

NCT04516408
(ClinicalTrials.gov)

October 1, 2020

13/8/2020

Recombinant Zoster Vaccine in Stable SLE Patients

Efficacy and Safety of Recombinant Zoster Vaccine in Stable SLE Patients(Vtrial)

Herpes Zoster;Recombinant Zoster Vaccine;Systemic Lupus Erythematosus

Biological: Recombinant zoster vaccine;Biological: Placebo

RenJi Hospital

NULL

Not yet recruiting

50 Years

N/A

All

464

N/A

NULL

NCT00775476
(ClinicalTrials.gov)

October 2020

17/10/2008

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine

Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine (NAC) (SNAC)

Systemic Lupus Erythematosus

Drug: N-acetylcysteine;Drug: Placebo

State University of New York - Upstate Medical University

NULL

Not yet recruiting

18 Years

N/A

All

290

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

EUCTR2019-003406-27-DE
(EUCTR)

17/09/2020

15/04/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus - PHOENYCS GO

Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

United States;Serbia;Portugal;Philippines;Estonia;Taiwan;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden

EUCTR2019-003406-27-AT
(EUCTR)

11/09/2020

29/05/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden

EUCTR2019-003406-27-GB
(EUCTR)

09/09/2020

15/07/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

EUCTR2019-002205-22-DE
(EUCTR)

12/08/2020

07/07/2020

SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;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

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom

NCT04294667
(ClinicalTrials.gov)

August 12, 2020

27/2/2020

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: DZP;Other: Placebo

UCB Biopharma SRL

NULL

Recruiting

16 Years

N/A

All

450

Phase 3

United States;Bulgaria;Canada;Chile;Hungary;Poland;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

NCT04433585
(ClinicalTrials.gov)

August 7, 2020

15/6/2020

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of LY3471851 (NKTR-358) in Adults With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: LY3471851;Drug: Placebo

Eli Lilly and Company

Nektar Therapeutics

Recruiting

18 Years

65 Years

All

280

Phase 2

United States;Argentina;Australia;Canada;Czechia;Germany;Hungary;India;Israel;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom

EUCTR2019-003406-27-GR
(EUCTR)

30/07/2020

02/06/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Australia;Peru;Canada;Argentina;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden

EUCTR2018-001808-11-GR
(EUCTR)

29/07/2020

16/07/2020

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of cenerimod in subjects with moderate to severe systemic lupus erythematosus (SLE) - CARE: Cenerimod Assessing S1P1 Receptor modulation in Systemic Lupus Erythematosus

Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Other descriptive name: ACT-334441

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2

United States;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Georgia;Bulgaria;Germany;China

EUCTR2019-003406-27-HU
(EUCTR)

28/07/2020

20/05/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden

NCT04451772
(ClinicalTrials.gov)

July 17, 2020

29/6/2020

A Study of the Safety of Oral Elsubrutinib Capsules and Oral Upadacitinib Tablets Given Alone or in Combination (ABBV-599) for Adult Participants With Moderately to Severely Active Systemic Lupus Erythematosus to Assess Change in Disease State

A Phase 2, Long-Term Extension (LTE) Study With Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

Systemic Lupus Erythematosus (SLE)

Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for Upadacitinib

AbbVie

NULL

Enrolling by invitation

18 Years

65 Years

All

260

Phase 2

United States;Argentina;Bulgaria;China;Germany;Hungary;Japan;Mexico;Netherlands;Poland;Puerto Rico;Spain;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

NCT04060888
(ClinicalTrials.gov)

July 14, 2020

16/8/2019

A Study of Ustekinumab in Chinese Participants With Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Chinese Subjects With Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 milligram (mg);Drug: Placebo

Janssen Research & Development, LLC

NULL

Withdrawn

18 Years

75 Years

All

Phase 3

China

NCT04305197
(ClinicalTrials.gov)

June 29, 2020

10/3/2020

A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: ICP-022;Drug: Placebos

Beijing InnoCare Pharma Tech Co., Ltd.

NULL

Recruiting

18 Years

75 Years

All

Phase 1;Phase 2

China

EUCTR2019-003406-27-BG
(EUCTR)

09/06/2020

21/04/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

EUCTR2019-003406-27-ES
(EUCTR)

02/06/2020

28/05/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

450

Phase 3

EUCTR2019-002205-22-GB
(EUCTR)

01/05/2020

07/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Poland;Belgium;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

EUCTR2019-002205-22-ES
(EUCTR)

06/04/2020

23/01/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom

EUCTR2019-002205-22-PL
(EUCTR)

29/03/2020

07/02/2020

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

185

Phase 2

United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom

NCT04058028
(ClinicalTrials.gov)

February 19, 2020

30/7/2019

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

A Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE) With Inadequate Response to Standard of Care (SOC) Therapy

Systemic Lupus Erythematosus (SLE)

Drug: AMG 570;Drug: Placebo for AMG 570

Amgen

NULL

Recruiting

18 Years

75 Years

All

300

Phase 2

United States;Argentina;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation

EUCTR2019-000638-20-NL
(EUCTR)

07/02/2020

09/12/2019

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

Product Code: ABBV-105
INN or Proposed INN: N/A
Other descriptive name: ABBV-105
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

325

Phase 2

United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of

EUCTR2019-000638-20-DE
(EUCTR)

22/01/2020

09/09/2019

Product Name: Elsubrutinib
Product Code: ABBV-105
INN or Proposed INN: Elsubrutinib
Other descriptive name: ABBV-105
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

325

Phase 2

United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Australia;Bulgaria;Germany;Netherlands;New Zealand;China;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

NCT04186871
(ClinicalTrials.gov)

January 7, 2020

28/11/2019

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome

Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo

Bristol-Myers Squibb

NULL

Recruiting

18 Years

65 Years

All

185

Phase 2

United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom

EUCTR2018-004175-12-GB
(EUCTR)

30/12/2019

23/07/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Product Name: PF-06700841
Product Code: PF-06700841 5mg
INN or Proposed INN: PF-06700841
Other descriptive name: PF-06700841 -15
Product Name: PF-06700841
Product Code: PF-06700841 25mg
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

448

Phase 2

Hong Kong;Greece;Spain;Ukraine;Colombia;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Japan;China;Korea, Republic of;United States;Serbia;Portugal;Taiwan

EUCTR2018-004175-12-PT
(EUCTR)

25/11/2019

30/07/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

Phase 2

United States;Portugal;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan

EUCTR2018-004175-12-ES
(EUCTR)

12/11/2019

11/11/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

Phase 2

EUCTR2017-005026-37-HR
(EUCTR)

24/10/2019

20/01/2020

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;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

NCT04275193
(ClinicalTrials.gov)

October 22, 2019

12/2/2020

The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus

The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Zishenqing;Drug: Placebo

Shanghai University of Traditional Chinese Medicine

RenJi Hospital

Recruiting

18 Years

65 Years

All

118

Phase 2;Phase 3

China

EUCTR2018-004175-12-BG
(EUCTR)

11/10/2019

30/07/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

Phase 2

Portugal;Serbia;United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Colombia;France;Australia;Netherlands;China;Korea, Republic of;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Japan

NCT04082416
(ClinicalTrials.gov)

October 10, 2019

1/9/2019

Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

A Phase III, Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-exploring Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: RC18 160 mg plus standard therapy

RemeGen

NULL

Recruiting

18 Years

65 Years

All

318

Phase 3

China

EUCTR2018-001808-11-DE
(EUCTR)

04/10/2019

18/10/2018

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod
Product Name: Cenerimod
Product Code: ACT-334441
INN or Proposed INN: Cenerimod

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2

United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China

EUCTR2018-004175-12-HU
(EUCTR)

23/09/2019

23/07/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

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

EUCTR2019-000638-20-HU
(EUCTR)

18/09/2019

02/10/2019

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

325

Phase 2

United States;Taiwan;Spain;Colombia;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Netherlands;Germany;New Zealand;China;Japan;Korea, Republic of

NCT04077684
(ClinicalTrials.gov)

September 10, 2019

1/9/2019

Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial

Systemic Lupus Erythematosus

Drug: Interleukin-2

Peking University People's Hospital

NULL

Recruiting

18 Years

75 Years

All

500

Phase 2

China

EUCTR2019-000638-20-ES
(EUCTR)

09/09/2019

27/09/2019

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

AbbVie Deutschland GmbH & Co. KG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

325

Phase 2

United States;Taiwan;Spain;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Romania;Australia;Germany;New Zealand;Japan;China;Korea, Republic of

EUCTR2018-004175-12-PL
(EUCTR)

03/09/2019

06/08/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

Phase 2

ChiCTR1900025376

2019-09-01

2019-08-25

Lenalidomide in Treatment-Refractory Lupus-Associated Skin Lesions in Systemic Lupus Erythematosus: A Single-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

systemic lupus erythematosus

intervention group:lenalidomide 10mg qd;control group:placebo 10mg qd;

Chinese Academy of Medical Sciences Peking Union Medical College Hospital

NULL

Recruiting

Both

intervention group:15;control group:15;

Phase 4

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

EUCTR2018-004175-12-CZ
(EUCTR)

21/08/2019

25/07/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

Phase 2

EUCTR2017-005026-37-NL
(EUCTR)

06/08/2019

13/05/2019

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China

EUCTR2017-005026-37-GR
(EUCTR)

26/07/2019

03/05/2019

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China

NCT03978520
(ClinicalTrials.gov)

July 25, 2019

3/6/2019

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Drug: Elsubrutinib;Drug: Placebo for Elsubrutinib;Drug: Upadacitinib;Drug: Placebo for upadacitinib

AbbVie

NULL

Recruiting

18 Years

65 Years

All

310

Phase 2

United States;Argentina;Australia;Bulgaria;Canada;China;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Puerto Rico;Spain;Taiwan;United Kingdom

NCT03951259
(ClinicalTrials.gov)

July 24, 2019

14/5/2019

Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of SM934 in Adult Subjects With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: SM934;Drug: Placebos

RenJi Hospital

Jiangsu ZuoYou Medicine Co., Ltd.

Recruiting

18 Years

70 Years

All

Phase 2

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

EUCTR2017-001203-79-ES
(EUCTR)

11/06/2019

30/04/2019

A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859 ;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

360

Phase 2

United States;Taiwan;Spain;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Korea, Republic of

NCT03804723
(ClinicalTrials.gov)

June 2019

11/1/2019

Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus

Glucocorticoids Withdrawal in Early Systemic Lupus Erythematosus: a Randomized Placebo-controlled Equivalence Trial

Systemic Lupus Erythematosus;Glucocorticoids;Therapy Withdrawal

Drug: oral Prednisone 5mg

University of Pisa

NULL

Not yet recruiting

18 Years

85 Years

All

321

N/A

NULL

NCT03933943
(ClinicalTrials.gov)

May 21, 2019

30/4/2019

A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: LY3361237;Drug: Placebo

Eli Lilly and Company

NULL

Recruiting

18 Years

70 Years

All

Phase 1

United States

EUCTR2018-001808-11-PL
(EUCTR)

17/05/2019

15/05/2019

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2

United States;Philippines;Taiwan;Greece;Thailand;Spain;Ukraine;Turkey;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China

NCT03949426
(ClinicalTrials.gov)

May 1, 2019

8/5/2019

Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects

A First-in-Human, Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Dose Study in Healthy Participants to Evaluate the Safety, Tolerability and Pharmacokinetics of KPG-818

Systemic Lupus Erythematosus

Drug: KPG-818

Kangpu Biopharmaceuticals, Ltd.

NULL

Completed

18 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

NCT03845517
(ClinicalTrials.gov)

April 18, 2019

15/2/2019

A DOSE-RANGING STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-06700841 IN SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: PF-06700841 15 mg;Drug: PF-06700841 30 mg;Drug: PF-06700841 45 mg

Pfizer

NULL

Recruiting

18 Years

75 Years

All

448

Phase 2

United States;Australia;Belgium;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Mexico;Poland;Portugal;Romania;Serbia;Spain;Taiwan;Ukraine;United Kingdom

NCT03917797
(ClinicalTrials.gov)

April 2, 2019

2/4/2019

Mesenchymal Stromal Cells (MSC´s) in Renal Lupus

Dose-response and Efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells in Renal Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic;Lupus Glomerulonephritis

Biological: MSC treatment;Drug: Standard of Care;Drug: Placebo

Universidad de los Andes, Chile

NULL

Recruiting

18 Years

75 Years

All

Phase 2

Chile

EUCTR2017-005026-37-GB
(EUCTR)

27/03/2019

19/09/2018

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China

EUCTR2018-001808-11-BG
(EUCTR)

20/03/2019

06/12/2018

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Moderate to severe systemic lupus erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2

United States;Taiwan;Spain;Thailand;Ukraine;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China

NCT03771885
(ClinicalTrials.gov)

March 16, 2019

10/12/2018

BI 705564 in Patients With Systemic Lupus Erythematosus (SLE)

A Phase Ib, Multicentre, Randomised, Double-blind, Placebo Controlled, 8 Week Crossover Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered BI 705564 in Patients With Systemic Lupus Erythematosus.

Lupus Erythematosus, Systemic

Drug: BI 705564;Drug: Placebo

Boehringer Ingelheim

NULL

Withdrawn

18 Years

N/A

All

Phase 1

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

ChiCTR1900020803

2019-03-01

2019-01-19

Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial

systemic lupus erythematosus

intervention group:melatonin 6mg qn;control group:placebo qn;

Chinese Academy of Medical Sciences Peking Union Medical College Hospital

NULL

Pending

Both

intervention group:88;control group:88;

Phase 4

China

EUCTR2018-001808-11-HU
(EUCTR)

08/02/2019

22/11/2018

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Idorsia Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 2

United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China

EUCTR2018-001508-12-FR
(EUCTR)

05/02/2019

13/11/2018

Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)

A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)

Systemic lupus erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of

EUCTR2017-001489-53-PT
(EUCTR)

04/02/2019

08/11/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

United States;Serbia;Portugal;Taiwan;Ecuador;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of

EUCTR2018-001808-11-ES
(EUCTR)

24/01/2019

16/11/2018

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Moderate to severe systemic lupus erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2

United States;Hong Kong;Taiwan;Spain;Thailand;Ukraine;Lithuania;Turkey;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;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

EUCTR2018-001808-11-FR
(EUCTR)

14/01/2019

31/08/2018

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 2

United States;Taiwan;Thailand;Spain;Ukraine;Turkey;Lithuania;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Poland;Romania;Bulgaria;Georgia;Germany;China

NCT03742037
(ClinicalTrials.gov)

December 21, 2018

12/11/2018

Efficacy and Safety of Four Doses of Cenerimod Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Subjects With Moderate to Severe Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Cenerimod 0.5 mg;Drug: Cenerimod 1 mg;Drug: Cenerimod 2 mg;Drug: Cenerimod 4 mg;Drug: Placebo

Idorsia Pharmaceuticals Ltd.

NULL

Recruiting

18 Years

75 Years

All

500

Phase 2

United States;Bulgaria;Czechia;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Mexico;Philippines;Poland;Romania;Russian Federation;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Lithuania

NCT03656562
(ClinicalTrials.gov)

December 19, 2018

19/7/2018

Study the Efficacy and Safety of VAY736 and CFZ533 in SLE Patients

A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE)

Drug: VAY736;Drug: VAY736 Placebo;Drug: CFZ533;Drug: CFZ533 Placebo

Novartis Pharmaceuticals

NULL

Recruiting

18 Years

75 Years

All

120

Phase 2

Argentina;Australia;China;Czechia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Thailand

EUCTR2017-005026-37-AT
(EUCTR)

18/12/2018

25/09/2018

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China

EUCTR2018-001808-11-GB
(EUCTR)

17/12/2018

17/09/2018

A research study to evaluate the effects of a new oral drug called cenerimod in adults with Systemic Lupus Erythematosus disease

Idorsia Pharmaceuticals Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

325

Phase 2

United States;Czechia;Philippines;Taiwan;Greece;Spain;Thailand;Ukraine;Turkey;Chile;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Mexico;Poland;Romania;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

EUCTR2017-005026-37-BE
(EUCTR)

17/12/2018

25/09/2018

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Brazil;Australia;Netherlands;Germany;China

NCT03817424
(ClinicalTrials.gov)

December 13, 2018

22/1/2019

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis

Drug: VIB7734;Drug: Placebo

Viela Bio

NULL

Completed

18 Years

75 Years

All

Phase 1

United States;Poland;Spain

EUCTR2018-001508-12-ES
(EUCTR)

12/12/2018

09/10/2018

Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)

Novartis Farmacéutica, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

120

Phase 2

Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of

EUCTR2018-001508-12-DE
(EUCTR)

05/12/2018

28/08/2018

Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)

A placebo-controlled, patient and investigator blinded, randomized parallelcohort study to assess pharmacodynamics, pharmacokinetics, safety,tolerability and preliminary clinical efficacy of VAY736 and CFZ533 inpatients with systemic lupus erythematosus (SLE)

Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736
Product Code: CFZ533
INN or Proposed INN: iscalimab
Other descriptive name: CFZ533

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

135

Phase 2

Taiwan;Thailand;Spain;Israel;Russian Federation;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of

NCT03878303
(ClinicalTrials.gov)

November 28, 2018

5/3/2019

Study of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)

A Phase 1b Double-Blind, Randomized, Placebo-Controlled Study of the Safety, Pharmacokinetics and Pharmacodynamics of AC0058TA in Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: AC0058TA;Drug: Placebo AC0058TA

ACEA Therapeutics, Inc.

Hangzhou ACEA Pharmaceutical Research Co., Ltd.

Recruiting

18 Years

75 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

NCT03724916
(ClinicalTrials.gov)

November 26, 2018

18/10/2018

A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-079 in Combination With Standard Background Therapy in Participants With Moderate to Severe Systemic Lupus Erythematosus (SLE)

A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TAK-079 in Combination With Standard Background Therapy in Patients With Moderate to Severe Systemic Lupus Erythematosus

Systemic Lupus Erythematosus;Lupus Erythematosus, Systemic

Drug: TAK-079;Drug: TAK-079 Placebo

Millennium Pharmaceuticals, Inc.

NULL

Recruiting

18 Years

75 Years

All

Phase 1

United States

EUCTR2017-005026-37-HU
(EUCTR)

19/11/2018

25/09/2018

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China

EUCTR2017-005026-37-CZ
(EUCTR)

12/11/2018

26/10/2018

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

825

Phase 3

United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China

EUCTR2018-001508-12-CZ
(EUCTR)

02/11/2018

28/08/2018

Study the efficacy and safety of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)

Systemic lupus erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Novartis Pharma AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

135

Phase 2

Taiwan;Spain;Thailand;Russian Federation;Israel;France;Czech Republic;Hungary;Argentina;Poland;Australia;Germany;China;Japan;Korea, Republic of

NCT02633163
(ClinicalTrials.gov)

October 26, 2018

15/12/2015

Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus

Systemic Lupus Erythematosus

Drug: Low Dose Mesenchymal Stem Cells (MSCs);Drug: High Dose Mesenchymal Stem Cells (MSCs);Drug: Placebo Infusion

Medical University of South Carolina

NULL

Recruiting

18 Years

65 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

NCT03626311
(ClinicalTrials.gov)

October 23, 2018

6/6/2018

Omega-3 Replacement With Krill Oil in Disease Management of SLE

A Double-Blind, Placebo-Controlled Randomized, Multicenter Study to Assess Changes in Omega-3 Index in Erythrocytes and Health Benefit After 24 Weeks of Daily Consumption of AKBM-3031 (Omega-3 Phospholipids From Krill), Followed by a 24 Week Open-Label Extension, in Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE)

Dietary Supplement: AKBM-3031;Other: Placebo

Aker Biomarine Antarctic AS

Ampel BioSolutions, LLC

Recruiting

18 Years

N/A

All

N/A

United States;Canada

EUCTR2017-001489-53-PL
(EUCTR)

24/09/2018

23/07/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of

EUCTR2017-005027-25-ES
(EUCTR)

21/09/2018

24/09/2018

A study of Baricitinib in patients with Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Eli Lilly and Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

750

Phase 3

Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France

NCT03527472
(ClinicalTrials.gov)

August 23, 2018

3/5/2018

Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

A Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Memantine for the Treatment of Cognitive Impairment in Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: Memantine;Drug: Placebo

Vanderbilt University Medical Center

Kleberg Foundation

Active, not recruiting

18 Years

60 Years

All

Phase 2

United States

JPRN-JapicCTI-183973

16/8/2018

29/05/2018

A Study of Ustekinumab in Participants with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Intervention name : Ustekinumab
INN of the intervention : Ustekinumab
Dosage And administration of the intervention : Participants will receive ustekinumab approximately 6 milligram per kilogram (mg/kg) intravenously (IV) based on body weight-range at Week 0 followed by 90 mg ustekinumab subcutaneously (SC) at Week 8 and every 8 weeks (q8w) thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will continue to receive 90 mg ustekinumab SC q8w through Week 160
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Participants will receive matching placebo to ustekinumab IV at Week 0, followed by matching placebo to ustekinumab SC at Week 8 and q8w thereafter through Week 48 during double-blind period. Eligible participants who will enter the extension period will cross-over to receive 90 mg ustekinumab SC q8w through Week 160.

Janssen Pharmaceutical K.K.

NULL

complete

BOTH

500

Phase 3

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

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03616912
(ClinicalTrials.gov)

August 2, 2018

1/8/2018

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Baricitinib;Drug: Placebo

Eli Lilly and Company

Incyte Corporation

Recruiting

18 Years

N/A

All

809

Phase 3

United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine

NCT03616964
(ClinicalTrials.gov)

August 2, 2018

1/8/2018

A Study of Baricitinib in Participants With Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Baricitinib;Drug: Placebo

Eli Lilly and Company

Incyte Corporation

Active, not recruiting

18 Years

N/A

All

750

Phase 3

United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain

EUCTR2017-001489-53-BG
(EUCTR)

27/06/2018

28/03/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of

EUCTR2017-001489-53-HU
(EUCTR)

14/06/2018

03/04/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

Portugal;United States;Serbia;Philippines;Taiwan;Ecuador;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Argentina;Poland;Romania;Australia;Peru;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of

EUCTR2017-001489-53-ES
(EUCTR)

12/06/2018

14/03/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

500

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

NCT03541564
(ClinicalTrials.gov)

May 30, 2018

17/5/2018

An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects

A Randomized, Double-Blind, Positive-Controlled, Placebo-Controlled, 4-Period Crossover Study to Investigate the Electrocardiographic Effects of BMS-986165 in Healthy Subjects

Systemic Lupus Erythematosus;Healthy Participants

Drug: BMS-986165;Drug: Moxifloxacin;Other: Placebo

Bristol-Myers Squibb

NULL

Completed

18 Years

50 Years

All

Phase 1

United States

EUCTR2016-000488-17-FR
(EUCTR)

16/05/2018

19/03/2019

A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)

Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2

ILTOO PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Portugal;France;Mexico;Spain;Austria;Bulgaria;Italy

EUCTR2017-001489-53-DE
(EUCTR)

08/05/2018

23/03/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

500

Phase 3

United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of

EUCTR2017-001489-53-LT
(EUCTR)

07/05/2018

19/03/2018

Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus - LOTUS

Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB
Trade Name: Stelara
INN or Proposed INN: ustekinumab
Other descriptive name: USTEKINUMAB

Janssen-Cilag International NV

NULL

Not Recruiting

Female: yes
Male: yes

500

Phase 3

United States;Serbia;Portugal;Taiwan;Thailand;Spain;Ukraine;Lithuania;Russian Federation;Colombia;Hungary;Canada;Argentina;Poland;South Africa;Bulgaria;Germany;China;Japan;Korea, Republic of

NCT03556007
(ClinicalTrials.gov)

May 1, 2018

7/5/2018

A Study of NKTR-358 (LY3471851) in Participants With Systemic Lupus Erythematosus (SLE)

A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous NKTR-358 in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: LY3471851;Drug: Placebo

Eli Lilly and Company

Nektar Therapeutics

Completed

18 Years

70 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

NCT03517722
(ClinicalTrials.gov)

April 16, 2018

13/4/2018

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: Placebo;Drug: Ustekinumab (approximately 6 mg/kg);Drug: Ustekinumab 90 mg

Janssen Research & Development, LLC

NULL

Active, not recruiting

16 Years

75 Years

All

516

Phase 3

United States;Argentina;Bulgaria;Canada;China;Colombia;Germany;Hungary;Japan;Korea, Republic of;Lithuania;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Ukraine;Australia;Ecuador;France;Peru;Philippines;Romania

NCT03451422
(ClinicalTrials.gov)

April 10, 2018

1/2/2018

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of AMG 592 in Participants With Systemic Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Multiple Ascending Subcutaneous Doses of AMG 592 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: AMG 592;Drug: Placebo

Amgen

NULL

Recruiting

18 Years

70 Years

All

Phase 1

United States;France;Germany;Poland

NCT03312907
(ClinicalTrials.gov)

March 1, 2018

13/10/2017

A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Belimumab;Drug: Rituximab;Drug: Rituximab-placebo;Drug: Standard therapy (Including Immunosuppressants);Drug: Standard therapy (Excluding Immunosuppressants);Drug: Steroid Taper

GlaxoSmithKline

NULL

Active, not recruiting

18 Years

N/A

All

292

Phase 3

United States;Argentina;Brazil;Canada;France;Germany;Korea, Republic of;Mexico;Netherlands;Russian Federation;Spain

NCT03396393
(ClinicalTrials.gov)

March 2018

4/1/2018

Exploratory Study of DHA in Systemic Lupus Erythematosus Patients

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Dihydroartemisinin tablet;Drug: Placebo tablet

Kunming Pharmaceuticals, Inc.

NULL

Not yet recruiting

18 Years

65 Years

All

120

Phase 2

NULL

100

EUCTR2016-003050-32-NL
(EUCTR)

16/02/2018

24/10/2017

A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Germany;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

101

NCT03371251
(ClinicalTrials.gov)

February 7, 2018

8/12/2017

Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care

Systemic Lupus Erythematosus

Drug: BOS161721;Drug: Placebo

Boston Pharmaceuticals

NULL

Completed

18 Years

70 Years

All

143

Phase 1;Phase 2

United States;Argentina;Bulgaria;Colombia;Georgia;Hungary;Mexico;Peru;Philippines;Poland;Romania;Ukraine

102

EUCTR2016-003050-32-DE
(EUCTR)

09/01/2018

21/06/2017

A Phase 3 Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

United States;Mexico;Canada;Argentina;Spain;Brazil;Russian Federation;Netherlands;Germany;Korea, Republic of

103

EUCTR2017-001203-79-PL
(EUCTR)

05/01/2018

03/11/2017

A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

360

Phase 2

Taiwan;Russian Federation;Israel;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Australia;Germany;Japan;Spain;Colombia;Korea, Republic of;United States

104

NCT03030118
(ClinicalTrials.gov)

December 28, 2017

15/1/2017

Study of Anti-Malarials in Incomplete Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Hydroxychloroquine;Drug: Placebo Oral Capsule

Milton S. Hershey Medical Center

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruiting

15 Years

49 Years

All

240

Phase 2

United States

105

NCT03093402
(ClinicalTrials.gov)

December 21, 2017

21/2/2017

JBT-101 in Systemic Lupus Erythematosus (SLE)

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (ALE09)

Systemic Lupus Erythematosus;SLE;Lupus

Drug: JBT-101;Drug: Placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Corbus Pharmaceuticals Inc.;Autoimmunity Centers of Excellence

Recruiting

18 Years

70 Years

All

100

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

106

EUCTR2016-003050-32-ES
(EUCTR)

05/12/2017

01/12/2017

A Phase 3 Study to Evaluate the Efficacy and Safety of BelimumabAdministered in Combination with Rituximab to Adult Subjects with Systemic Lupus Erythematosus (SLE) – BLISS-BELIEVE

Systemic Lupus Erythematosus (SLE) or Lupus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA

GlaxoSmithKline, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

200

Phase 3

United States;Mexico;Canada;Argentina;Brazil;Spain;Russian Federation;South Africa;Netherlands;Korea, Republic of

107

EUCTR2017-001203-79-HU
(EUCTR)

04/12/2017

04/10/2017

A clinical study to test the efficacy and safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000017968;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: BMS-986165
Product Code: BMS-986165
INN or Proposed INN: BMS-986165

Bristol-Myers Squibb international Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

400

Phase 2

United States;Taiwan;Ukraine;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Peru;Bulgaria;Germany;Japan;Korea, Republic of

108

EUCTR2016-004574-17-FR
(EUCTR)

30/11/2017

28/11/2018

A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany

109

NCT03334851
(ClinicalTrials.gov)

November 17, 2017

3/11/2017

Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis

A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS

Systemic Lupus Erythematosus;Rheumatoid Arthritis

Drug: PF-06835375;Drug: Placebo

Pfizer

NULL

Recruiting

18 Years

70 Years

All

112

Phase 1

United States;Puerto Rico

110

EUCTR2016-004574-17-BE
(EUCTR)

14/11/2017

07/06/2017

A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: CC -220
INN or Proposed INN: CC -220
Other descriptive name: CC -220
Product Code: CC -220
INN or Proposed INN: CC -220
Other descriptive name: CC -220
Product Code: CC -220
INN or Proposed INN: CC -220
Other descriptive name: CC -220

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

United States;Serbia;Spain;Russian Federation;Colombia;Italy;France;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;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

111

EUCTR2016-004574-17-DE
(EUCTR)

27/09/2017

21/04/2017

A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Not Recruiting

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany

112

NCT03054259
(ClinicalTrials.gov)

September 21, 2017

17/1/2017

Rituximab Objective Outcome Measures Trial in SLE

A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Arthritis

Drug: Rituximab;Drug: Methylprednisolone;Drug: Normal Saline

University of Leeds

NULL

Recruiting

18 Years

99 Years

All

Phase 2

United Kingdom

113

NCT03161483
(ClinicalTrials.gov)

July 6, 2017

18/5/2017

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Lupus Erythematosus, Systemic

Drug: CC -220;Other: Placebo

Celgene

NULL

Active, not recruiting

18 Years

N/A

All

289

Phase 2

United States;Argentina;Belgium;Brazil;Canada;Colombia;France;Germany;Hungary;Italy;Mexico;Poland;Russian Federation;Serbia;Spain

114

NCT03189017
(ClinicalTrials.gov)

July 3, 2017

12/6/2017

A Phase I Study of ICP-022 in Healthy Subjects

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ICP-022 Following Single and Multiple Escalating Dose

Systemic Lupus Erythematosus;Rheumatoid Arthritis

Drug: ICP-022;Drug: Placebos

Innocare Pharma Australia Pty Ltd

NULL

Completed

18 Years

55 Years

Male

Phase 1

Australia

115

NCT02920424
(ClinicalTrials.gov)

June 30, 2017

29/9/2016

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-56022473 in Subjects With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: JNJ-56022473;Drug: Placebo

Janssen Research & Development, LLC

NULL

Withdrawn

18 Years

65 Years

All

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

116

EUCTR2016-002950-19-DE
(EUCTR)

19/06/2017

12/04/2017

A Phase II Study of M2951 in SLE

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A

Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

468

Phase 2

United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of

117

EUCTR2016-004574-17-HU
(EUCTR)

19/06/2017

13/04/2017

A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany

118

NCT03252587
(ClinicalTrials.gov)

June 13, 2017

15/8/2017

An Investigational Study to Evaluate BMS-986165 in Patients With Systemic Lupus Erythematosus

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: BMS-986165;Other: Placebo

Bristol-Myers Squibb

NULL

Recruiting

18 Years

75 Years

All

360

Phase 2

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine

119

EUCTR2015-004359-32-PL
(EUCTR)

10/06/2017

24/04/2017

Study to Evaluate BIIB059 in CLE with or without SLE

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects with Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects with Active Cutaneous Lupus Erythematosus with or without Systemic Manifestations.

Systemic Lupus Erythematosus (SLE) with Active Skin Manifestations and Active Cutaneous Lupus Erythematosus (CLE) with or without Systemic Manifestations
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BIIB059
Product Code: BIIB059
INN or Proposed INN: Not Available
Other descriptive name: anti-blood dendritic cell antigen 2

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;Korea, Republic of

120

EUCTR2016-004574-17-ES
(EUCTR)

08/06/2017

07/04/2017

A study to measure how safe CC-220 is and how well CC-220 works in people with lupus.

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLEBLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-220 IN SUBJECTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Celgene Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 2

Serbia;United States;Spain;Russian Federation;Colombia;Italy;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;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

121

EUCTR2016-000625-39-BG
(EUCTR)

17/05/2017

08/03/2017

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - Tulip SLE LTE

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand

122

EUCTR2016-002950-19-BG
(EUCTR)

27/04/2017

27/03/2017

A Phase II Study of M2951 in SLE

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A

Product Name: Evobrutinib
Product Code: M2951
INN or Proposed INN: Evobrutinib
Other descriptive name: M2951

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

468

Phase 2

United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Poland;Brazil;Malaysia;Romania;Peru;Bulgaria;South Africa;Germany;Japan;Korea, Republic of

123

JPRN-JapicCTI-173544

26/4/2017

23/03/2017

TULIP SLE LTE

Active Systemic Lupus Erythematosus

Intervention name : Anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses

AstraZeneca

NULL

complete

BOTH

Phase 3

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

124

EUCTR2016-002950-19-PL
(EUCTR)

25/04/2017

28/03/2017

A Phase II Study of M2951 in SLE

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects with Systemic Lupus Erythematosus (SLE) - N/A

Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck KGaA

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

468

Phase 2

United States;Philippines;Taiwan;Russian Federation;Chile;Colombia;Italy;Mexico;Mauritius;Argentina;Malaysia;Poland;Brazil;Romania;Peru;South Africa;Bulgaria;Germany;Japan;Korea, Republic of

125

EUCTR2015-001341-86-BG
(EUCTR)

10/04/2017

16/02/2017

Phase IIb study of IFN-K in Systemic Lupus Erythematosus

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Neutralization of the Interferon Gene Signature and the Clinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic Lupus Erythematosus - Phase IIb study of IFN-K in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 19.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance

Neovacs S.A.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2

United States;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;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

126

NCT03355482
(ClinicalTrials.gov)

April 10, 2017

22/11/2017

MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE

Systemic Lupus Erythematosus Arthritis

Drug: Methylprednisolone;Drug: Placebos

Oklahoma Medical Research Foundation

Bristol-Myers Squibb

Recruiting

18 Years

70 Years

All

Phase 2

United States

127

EUCTR2016-001039-11-DE
(EUCTR)

03/04/2017

22/12/2016

A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of

128

EUCTR2016-000488-17-BG
(EUCTR)

27/03/2017

13/02/2017

A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)

Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: Aldesleukin
Other descriptive name: INTERLEUKIN-2

ILTOO PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Portugal;France;Mexico;Spain;Romania;Austria;Bulgaria;Germany;Italy

129

EUCTR2016-000488-17-IT
(EUCTR)

02/03/2017

10/05/2019

A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)

A Phase II, multi-centre, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety and pharmacokinetics of ILT-101 in patients with active moderate to severe systemic lupus erythematosus (SLE) - A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage o

Product Name: ILT-101
Product Code: ILT-101
INN or Proposed INN: ALDESLEUCHINA
Other descriptive name: ALDESLEUCHINA

ILTOO PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

France;Portugal;Spain;Austria;Bulgaria;Italy

130

NCT03042260
(ClinicalTrials.gov)

March 1, 2017

10/1/2017

Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

Prophylactic Trimethoprim-Sulfamethoxazole for the Prevention of Serious Infections in Patients With Systemic Lupus Erythematosus: a Randomized Placebo Controlled Trial

Lupus Erythematosus, Systemic

Drug: Trimethoprim -Sulfamethoxazole;Drug: Placebo Oral Tablet

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

National Council of Science and Technology, Mexico

Recruiting

18 Years

N/A

All

310

Phase 4

Mexico

No.

TrialID

Date_
enrollment

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

EUCTR2015-001341-86-ES
(EUCTR)

01/03/2017

27/12/2016

Phase IIb study of IFN-K in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance

Neovacs S.A.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2

132

EUCTR2016-001039-11-BG
(EUCTR)

20/02/2017

08/11/2016

A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITHMODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Product Name: GDC-0853
Product Code: RO7010939/F13
INN or Proposed INN: not available yet
Other descriptive name: GDC-0853 RO7010939

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of

133

NCT02962960
(ClinicalTrials.gov)

February 14, 2017

23/9/2016

A Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab in Adult Type I Interferon Test High Systemic Lupus Erythematosus Subject With Active Skin Manifestations

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab Following Subcutaneous Administration in Adult Systemic Lupus Erythematosus Subjects With Type I Interferon Test High Result and Active Skin Manifestations.

Systemic Lupus Erythematosus

Drug: Anifrolumab;Drug: Placebo

AstraZeneca

NULL

Completed

18 Years

70 Years

All

Phase 2

United States;Hungary;Korea, Republic of;Poland

134

EUCTR2016-001039-11-ES
(EUCTR)

07/02/2017

26/10/2016

A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of

135

EUCTR2015-004359-32-BG
(EUCTR)

01/02/2017

03/11/2016

Study to Evaluate BIIB059 in CLE with or without SLE

Product Name: BIIB059
Product Code: BIIB059
INN or Proposed INN: Not Available
Other descriptive name: anti-blood dendritic cell antigen 2

Biogen Idec Research Limited

NULL

Not Recruiting

Female: yes
Male: yes

320

Phase 2

United States;Serbia;Philippines;Taiwan;Mexico;Argentina;Thailand;Poland;Israel;Bulgaria;Colombia;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

136

EUCTR2016-001039-11-PT
(EUCTR)

30/01/2017

23/09/2016

A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

Portugal;United States;Taiwan;Spain;Chile;Colombia;United Kingdom;France;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of

137

EUCTR2016-003246-93-PL
(EUCTR)

26/01/2017

13/12/2016

The purpose of this study is to investigate how a new experimental medication called anifrolumab is distributed in the body when given as subcutaneous (under the skin) injections to subjects with the autoimmune disease called Systemic Lupus Erythematosus (SLE), also known as Lupus. The study will also explore if anifrolumab may improve Lupus skin symptoms.

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Characterizing the Pharmacokinetics, Pharmacodynamics, and Safety of Anifrolumab following subcutaneous administration in Adult Systemic Lupus Erythematosus Subjects with Type I Interferon test high result and active skin manifestations

Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: ANIFROLUMAB
Other descriptive name: Immunoglobulin G1, anti-(human type I interferon receptor) (human monoclonal MEDI-546 heavy chain), disulfide with human monoclonal MEDI-546-chain, dimer

Astrazeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

United States;Hungary;Poland;Korea, Republic of

138

JPRN-JapicCTI-183957

20/1/2017

14/05/2018

A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 low dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 mid dose will be administered for 52 weeks in double-blind treatment period.

Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 high dose will be administered for 52 weeks in double-blind treatment period.
Intervention name : M2951 (Other Name: Evobrutinib)
INN of the intervention : -
Dosage And administration of the intervention : M2951 will be administered for 104 weeks in open-lable extension period at a dose of 50 milligrams twice a day.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo matched to M2951 will be administered for 52 weeks in double-blind treatment period.

Merck Biopharma Co., Ltd

Merck KGaA

complete

BOTH

480

Phase 2

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

139

NCT02908100
(ClinicalTrials.gov)

January 19, 2017

14/9/2016

A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus

A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: GDC-0853;Drug: Placebo

Genentech, Inc.

NULL

Completed

18 Years

75 Years

All

260

Phase 2

United States;Argentina;Brazil;Bulgaria;Chile;Colombia;Germany;Korea, Republic of;Mexico;Spain;Taiwan;United Kingdom;France;Portugal;Thailand

140

NCT02955615
(ClinicalTrials.gov)

January 18, 2017

17/10/2016

ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

A Phase II, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ILT-101 in Patients With Active Moderate to Severe Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: ILT-101;Drug: Placebo

Iltoo Pharma

NULL

Completed

18 Years

N/A

All

100

Phase 2

Austria;Bulgaria;France;Germany;Italy;Mauritius;Mexico;Portugal;Romania;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

141

NCT02975336
(ClinicalTrials.gov)

January 4, 2017

23/11/2016

A Phase II Study of M2951 in Systemic Lupus Erythematosus (SLE)

A Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study To Evaluate the Safety and Efficacy of M2951 in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: M2951

EMD Serono Research & Development Institute, Inc.

Merck KGaA, Darmstadt, Germany

Terminated

18 Years

75 Years

All

480

Phase 2

United States;Argentina;Bulgaria;Chile;Colombia;Germany;Italy;Japan;Korea, Republic of;Malaysia;Mauritius;Mexico;Peru;Philippines;Poland;Romania;Russian Federation;South Africa;Taiwan

142

NCT02953821
(ClinicalTrials.gov)

December 16, 2016

1/11/2016

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Acthar Gel in Subjects With Persistently Active Systemic Lupus Erythematosus Despite Moderate Dose Corticosteroids

Lupus Erythematosus, Systemic

Drug: Acthar Gel;Drug: Placebo Gel

Mallinckrodt

NULL

Completed

18 Years

N/A

All

172

Phase 4

United States;Argentina;Chile;Mexico;Peru;Colombia

143

EUCTR2016-000625-39-DE
(EUCTR)

13/12/2016

05/07/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

144

EUCTR2016-003246-93-HU
(EUCTR)

06/12/2016

19/10/2016

Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Astrazeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

United States;Hungary;Poland;Korea, Republic of

145

EUCTR2016-000488-17-ES
(EUCTR)

21/11/2016

18/11/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)

Systematic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

ILTOO PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

France;Portugal;Mexico;Spain;Austria;Bulgaria;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

146

EUCTR2016-001039-11-GB
(EUCTR)

16/11/2016

24/08/2016

A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus

A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Genentech, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

240

Phase 2

United States;Portugal;Taiwan;Spain;Chile;Colombia;United Kingdom;Mexico;Argentina;Brazil;Bulgaria;Germany;Korea, Republic of

147

EUCTR2015-004457-40-PL
(EUCTR)

04/11/2016

02/09/2016

A clinical trial undertaken around the world in adult patients with lupus erythematosus currently havingsymptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or aninactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctornor the patient will know which additional treatment is given.

A MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY FOLLOWED BY AN OBSERVATIONAL PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF DAPIROLIZUMAB PEGOL IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

SUBJECTSWITH MODERATELY TO SEVERELY ACTIVE SYSTEMICLUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany

148

EUCTR2016-000625-39-LT
(EUCTR)

03/11/2016

17/08/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;France;Australia;Peru;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;Japan

149

EUCTR2016-000488-17-PT
(EUCTR)

24/10/2016

28/07/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)

Systematic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

ILTOO PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

France;Portugal;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy

150

NCT02847598
(ClinicalTrials.gov)

October 20, 2016

6/6/2016

Study to Evaluate BIIB059 in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)

A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations

Systemic Lupus Erythematosus;Active Cutaneous Lupus Erythematosus

Drug: BIIB059;Drug: Placebo

Biogen

NULL

Completed

18 Years

75 Years

All

264

Phase 2

United States;Argentina;Bulgaria;Colombia;Israel;Korea, Republic of;Mexico;Philippines;Poland;Serbia;Taiwan;Thailand

No.

TrialID

Date_
enrollment

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

EUCTR2015-003341-25-GB
(EUCTR)

17/10/2016

22/09/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.

A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus - A study to evaluate the effectiveness and safety of the study drug for patients with SLE.

Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

ImmuPharma SA

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

France;United States;Hungary;Germany;United Kingdom

152

EUCTR2015-004457-40-ES
(EUCTR)

10/10/2016

05/08/2016

SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS.
MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657
Product Name: Dapirolizumab pegol (DZP)
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany

153

EUCTR2015-004457-40-HU
(EUCTR)

20/09/2016

13/07/2016

A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.

SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany

154

EUCTR2015-004457-40-DE
(EUCTR)

19/09/2016

22/06/2016

A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.

SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 20.0;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;Bulgaria;Germany

155

EUCTR2015-004457-40-BG
(EUCTR)

13/09/2016

03/08/2016

A clinical trial undertaken around the world in adult patients with lupus erythematosus currently having symptoms. These patients are randomly (like flipping a coin) given a drug (at 3 different doses) or an inactive drug in addition to their usual medication given for lupus. Neither the sponsor nor the doctor nor the patient will know which additional treatment is given.

SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
MedDRA version: 19.1;Level: LLT;Classification code 10040967;Term: SLE;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]

UCB Biopharma SPRL

NULL

Not Recruiting

Female: yes
Male: yes

160

Phase 2

United States;Spain;Ukraine;Chile;Russian Federation;Colombia;Hungary;Mexico;Poland;Romania;Peru;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

156

EUCTR2016-000625-39-ES
(EUCTR)

24/08/2016

15/07/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

157

EUCTR2016-000625-39-HU
(EUCTR)

18/08/2016

23/06/2016

A study to characterize the safety and tolerability of Anifrolumab in adult patients with Systemic Lupus Erythematosus

Product Name: Anifrolumab
Product Code: MEDI-546
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

575

Phase 3

United States;Taiwan;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Australia;South Africa;Korea, Republic of;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Germany;Japan;New Zealand

158

EUCTR2016-000488-17-AT
(EUCTR)

08/08/2016

21/07/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given dosage of ILT-101 with active moderate to severe systemic lupus erythematosus(SLE)

Systematic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

ILTOO PHARMA

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

Portugal;France;Mexico;Mauritius;Spain;Romania;Austria;Bulgaria;Germany;Italy

159

EUCTR2015-003341-25-DE
(EUCTR)

29/07/2016

17/03/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.

Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

ImmuPharma SA

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

France;United States;Hungary;Germany;United Kingdom

160

NCT02794285
(ClinicalTrials.gov)

June 30, 2016

6/6/2016

Long Term Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Biological: Anifrolumab;Drug: Placebo

AstraZeneca

PRA Health Sciences

Active, not recruiting

18 Years

70 Years

All

559

Phase 3

United States;Argentina;Australia;Bulgaria;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Lithuania;Mexico;Peru;Poland;Romania;Russian Federation;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Belgium;Brazil;Czech Republic;Czechia;Italy;New Zealand;Singapore

No.

TrialID

Date_
enrollment

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

NCT03155477
(ClinicalTrials.gov)

June 10, 2016

13/5/2017

Effect Of Curcuma Xanthorrhiza and Vitamin D3 Supplementation in SLE Patients With Hypovitamin D

Effect Of Curcuma Xanthorrhiza Supplementation In Systemic Lupus Erythematosus Patients (SLE) With Hypovitamin D Which Were Given Vitamin D3 Towards Disease Activity (SLEDAI), Interleukin-6 (IL-6) And Tumor Growth Factor-ß1 (TGF-ß1) Serum

SLE

Dietary Supplement: Cholecalciferol and C. Xanthorrhiza;Dietary Supplement: Cholecalciferol and placebo

Saiful Anwar Hospital

NULL

Completed

18 Years

45 Years

Female

N/A

NULL

162

NCT02804763
(ClinicalTrials.gov)

June 2, 2016

14/6/2016

A Phase 2 Efficacy and Safety Study of Dapirolizumab Pegol (DZP) in Systemic Lupus Erythematosus

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Followed by an Observational Period to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Drug: Placebo;Drug: Dapirolizumab pegol (DZP)

UCB Biopharma S.P.R.L.

NULL

Completed

18 Years

N/A

All

182

Phase 2

United States;Bulgaria;Chile;Colombia;Germany;Hungary;Mexico;Peru;Poland;Romania;Russian Federation;Spain;Ukraine

163

NCT02514967
(ClinicalTrials.gov)

June 2016

31/7/2015

CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Systemic Lupus Erythematosus

Drug: Blisibimod;Drug: Placebo

Anthera Pharmaceuticals

NULL

Terminated

18 Years

N/A

All

Phase 3

Georgia

164

NCT02741960
(ClinicalTrials.gov)

May 24, 2016

7/4/2016

The Effect of Metformin on Reducing Lupus Flares

A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: metformin;Drug: placebo

RenJi Hospital

NULL

Completed

18 Years

70 Years

All

180

Phase 4

China

165

EUCTR2015-003341-25-HU
(EUCTR)

02/05/2016

07/03/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.

Systemic Lupus Erythematosus
MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Code: IPP-201101
INN or Proposed INN: IPP-201101

ImmuPharma SA

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

France;United States;Hungary;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

166

EUCTR2015-004404-35-ES
(EUCTR)

29/04/2016

04/04/2016

A study in Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB

Lilly S.A.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of

167

EUCTR2015-004404-35-FR
(EUCTR)

12/04/2016

04/05/2016

A study in Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of

168

EUCTR2015-004404-35-PL
(EUCTR)

12/04/2016

31/03/2016

A study in Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of

169

EUCTR2015-004404-35-AT
(EUCTR)

06/04/2016

24/03/2016

A study in Lupus

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of

170

NCT02331810
(ClinicalTrials.gov)

April 2016

5/12/2014

Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients

A Randomized, Double-blind, Placebo-controlled Study Of Safety, Tolerability, And Pharmacokinetics Of Repeated Ascending Subcutaneous Doses Of SAR113244 And Pharmacodynamics Of Single Dose Of SAR113244 In Male And Female Lupus Patient

Systemic Lupus Erythematosus

Drug: SAR113244;Drug: placebo

Sanofi

NULL

Withdrawn

18 Years

75 Years

Both

Phase 1

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

171

NCT02618967
(ClinicalTrials.gov)

March 28, 2016

13/10/2015

Single Ascending Dose Study of AMG 570 in Healthy Subjects

A Randomized, Double Blind Placebo Controlled, First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of AMG 570 in Healthy Subjects

Systemic Lupus Erythematosus

Biological: AMG 570;Biological: AMG 570 Matching Placebo

Amgen

NULL

Completed

18 Years

65 Years

All

Phase 1

United States

172

NCT02708095
(ClinicalTrials.gov)

March 24, 2016

10/3/2016

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Baricitinib;Drug: Placebo

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

314

Phase 2

United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan

173

JPRN-JapicCTI-163359

01/3/2016

A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH

Systemic Lupus Erythematosus (SLE)

Intervention name : Baricitinib
INN of the intervention : Baricitinib
Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks

Eli Lilly Japan K.K.

NULL

BOTH

Phase 2

NULL

174

NCT02711813
(ClinicalTrials.gov)

March 2016

14/3/2016

TAB08 in Patients With Systemic Lupus Erythematosus (SLE), Not Adequately Controlled With Current Treatment

Study to Assess Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of TAB08 in Patients With Systemic Lupus Erythematosus, Not Adequately Controlled With Current Concomitant Therapy

Lupus Erythematosus, Systemic

Drug: TAB08;Other: Placebo

Theramab LLC

NULL

Terminated

18 Years

60 Years

All

Phase 2

Russian Federation

175

EUCTR2015-003341-25-FR
(EUCTR)

24/02/2016

20/04/2016

A study to evaluate the effectiveness and safety of the study drug, when patients are given a 200-mcg dosage of IPP-201101 plus standard of care in patients with systemic lupus erythematosus.

Product Code: IPP-201101
INN or Proposed INN: IPP-201101

ImmuPharma SA

NULL

Not Recruiting

Female: yes
Male: yes

200

Phase 3

United States;France;Hungary;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

176

NCT02725515
(ClinicalTrials.gov)

February 16, 2016

8/1/2016

A Study of the Effect of XmAb®5871 in Patients With Systemic Lupus Erythematosus

A Randomized, Double-Blinded, Placebo-Controlled Study of the Effect of XmAb®5871 on Systemic Lupus Erythematosus Disease Activity

Systemic Lupus Erythematosus

Biological: XmAb5871;Biological: Placebo to match XmAb5871

Xencor, Inc.

PPD;ICON plc

Completed

18 Years

65 Years

All

105

Phase 2

United States

177

NCT02660944
(ClinicalTrials.gov)

January 3, 2016

16/1/2016

A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: RSLV-132;Drug: Placebo

Resolve Therapeutics

NULL

Completed

18 Years

70 Years

All

Phase 2

United States

178

NCT02483624
(ClinicalTrials.gov)

January 2016

23/6/2015

3,3'-Diindolylmethane in Patients With Systemic Lupus Erythematosus

A Single-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of 3,3'-Diindolylmethane (BR-DIM) in Patients With Systemic Lupus Erythematosus (SLE)

SLE

Drug: BR-DIM;Drug: Placebo

North Shore Long Island Jewish Health System

NULL

Terminated

18 Years

50 Years

Female

Phase 1

NULL

179

EUCTR2014-002184-14-NL
(EUCTR)

22/12/2015

03/09/2015

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: lulizumab pegol
Product Code: BMS-931699
INN or Proposed INN: lulizumab pegol
Other descriptive name: Anti-CD28dAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of

180

EUCTR2014-004632-19-BG
(EUCTR)

11/12/2015

27/10/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;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

181

NCT02074020
(ClinicalTrials.gov)

December 2015

26/2/2014

CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Systemic Lupus Erythematosus

Drug: Blisibimod;Drug: Placebo

Anthera Pharmaceuticals

NULL

Withdrawn

18 Years

N/A

Both

Phase 3

NULL

182

NCT02885610
(ClinicalTrials.gov)

December 2015

26/8/2016

Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)

A Phase IIb , Placebo-Controlled ,Multi-Center, Randomized, Double-Blind, Dose-explorating Trial of RC18,a Recombinant Human B Lymphocyte Stimulating Factor Receptor-Antibody Fusion Protein in Subjects With Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: RC18 80 mg plus standard therapy;Biological: RC18 160 mg plus standard therapy;Biological: RC18 240 mg plus standard therapy

RemeGen

NULL

Completed

18 Years

65 Years

All

249

Phase 2

China

183

NCT02609789
(ClinicalTrials.gov)

December 2015

18/11/2015

A Single Ascending Dose Study in Healthy Participants and Multiple Dose Study of JNJ-55920839 in Participants With Mild to Moderate Systemic Lupus Erythematosus

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Dose Study of JNJ-55920839 in Subjects With Mild to Moderate Systemic Lupus Erythematosus

Systemic Lupus Erythematosus;Healthy

Drug: JNJ-55920839;Drug: Placebo

Janssen Research & Development, LLC

NULL

Completed

18 Years

55 Years

All

Phase 1

United States;Belgium;Moldova, Republic of;Poland;Romania;Spain;Taiwan

184

NCT02537028
(ClinicalTrials.gov)

November 30, 2015

28/8/2015

MSC2364447C Phase 1b in Systemic Lupus Erythematosus

A Phase Ib Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biological Effect of MSC2364447C in Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: MSC2364447C;Drug: Placebo

EMD Serono Research & Development Institute, Inc.

Merck KGaA

Completed

18 Years

65 Years

All

Phase 1

United States;Bulgaria

185

EUCTR2014-004633-96-RO
(EUCTR)

26/11/2015

08/10/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;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

186

EUCTR2015-001341-86-DE
(EUCTR)

19/11/2015

01/09/2015

Phase IIb study of IFN-K in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Neovacs S.A.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2

187

EUCTR2014-004632-19-DE
(EUCTR)

12/11/2015

06/08/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;South Africa;Germany;Korea, Republic of

188

EUCTR2014-004633-96-DE
(EUCTR)

12/11/2015

28/05/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab
Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Brazil;Poland;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of

189

NCT02477150
(ClinicalTrials.gov)

November 2015

17/6/2015

Safety and Immunogenicity of a Zoster Vaccine in SLE

Immunogenicity and Safety of a Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus: a Randomized Controlled Trial

Systemic Lupus Erythematosus

Biological: Zostavax;Biological: placebo

Tuen Mun Hospital

NULL

Completed

18 Years

N/A

All

Phase 4

China

190

EUCTR2015-001341-86-HR
(EUCTR)

23/10/2015

10/11/2015

Phase IIb study of IFN-K in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance

Neovas S.A.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2

Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of;United States;Philippines;Taiwan;Spain;Thailand;Russian Federation;Chile;Colombia;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

191

JPRN-JapicCTI-153077

21/10/2015

20/11/2015

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of lulizumab pegol of Subjects with Active Systemic Lupus Erythematosus

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of lulizumab pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Intervention name : Lulizumab pegol
INN of the intervention : -
Dosage And administration of the intervention : Four treatments of lulizumab pegol will be administered along with placebo treatment:12.5 mg weekly, 12.5 mg every other week (EOW), 5 mg EOW and 1.25mg EOW, on a background of limited standard of care medications. The dose levels may be modified based on the interim analysis results.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -

Bristol-Myers Squibb K.K.

NULL

complete

BOTH

350

Phase 2

Japan, Asia except Japan, North America, South America, Europe

192

NCT02349061
(ClinicalTrials.gov)

October 15, 2015

23/1/2015

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: Ustekinumab IV;Drug: Placebo Infusion;Drug: Placebo SC;Drug: Ustekinumab SC;Other: Concomitant Medication

Janssen Research & Development, LLC

NULL

Completed

18 Years

75 Years

All

102

Phase 2

United States;Argentina;Australia;Germany;Hungary;Mexico;Poland;Spain;Taiwan;United Kingdom

193

EUCTR2014-004633-96-PL
(EUCTR)

14/10/2015

05/08/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Australia;Peru;Germany;New Zealand;Korea, Republic of

194

EUCTR2015-000372-95-DE
(EUCTR)

08/10/2015

17/06/2015

Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

A Phase II Multicenter, Randomized, Double-blind, Placebo controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX 0061 Administered Subcutaneously in Subjects with Moderate to Severe Active Systemic Lupus Erythematosus - STEADY

Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody

Ablynx N.V.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of

195

NCT02429934
(ClinicalTrials.gov)

October 2015

24/4/2015

Abatacept for SLE Arthritis (IM101-330)

Efficacy of Abatacept in Inflammatory Polyarthritis of Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus Arthritis

Drug: abatacept;Drug: Placebo

University of California, Los Angeles

Bristol-Myers Squibb

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

196

NCT02554019
(ClinicalTrials.gov)

September 28, 2015

16/9/2015

Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated Dose, Multicentre Phase IIa Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: BT063;Biological: Placebo

Biotest

NULL

Completed

18 Years

75 Years

All

Phase 2

Belarus;Georgia;Poland;Serbia

197

EUCTR2015-000372-95-HU
(EUCTR)

24/09/2015

30/06/2015

Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody

Ablynx N.V.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Hungary;Czech Republic;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of

198

EUCTR2014-004632-19-CZ
(EUCTR)

23/09/2015

28/07/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anifrolumab
INN or Proposed INN: Anifrolumab

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

199

NCT02665364
(ClinicalTrials.gov)

September 23, 2015

17/11/2015

Phase IIb Study of IFN-K in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: IFNa-Kinoid;Other: Placebo;Other: ISA 51 VG

Neovacs

NULL

Terminated

18 Years

65 Years

All

185

Phase 2

United States;Argentina;Belgium;Chile;Colombia;Croatia;France;Georgia;Germany;Italy;Korea, Republic of;Mexico;Moldova, Republic of;Peru;Philippines;Poland;Russian Federation;Switzerland;Taiwan;Thailand;Tunisia

200

EUCTR2014-005000-19-PL
(EUCTR)

22/09/2015

18/08/2015

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Trade Name: STELARA ®
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab
Product Name: Ustekinumab
Product Code: CNTO1275
INN or Proposed INN: ustekinumab

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

102

Phase 2

United States;Hungary;Taiwan;Mexico;Argentina;Spain;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

201

EUCTR2014-004632-19-ES
(EUCTR)

21/09/2015

24/06/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

202

EUCTR2015-001341-86-IT
(EUCTR)

19/09/2015

10/11/2020

Phase IIb study of IFN-K in Systemic Lupus Erythematosus

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Neutralization of the Interferon Gene Signature and theClinical Efficacy of IFNa-Kinoid in Adult Subjects with Systemic LupusErythematosus - IFN-K-002

Product Name: IFN-Kinoid
Product Code: IFN-K

NEOVACS

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2

United States;Philippines;Taiwan;Spain;Thailand;Korea, Democratic People's Republic of;Russian Federation;Chile;Colombia;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Peru;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Korea, Republic of

203

EUCTR2014-004633-96-IT
(EUCTR)

16/09/2015

21/01/2020

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus - NA

Systemic Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

ASTRAZENECA AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;Italy;United Kingdom;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

204

EUCTR2014-005526-35-PL
(EUCTR)

12/09/2015

10/08/2015

Clinical study to evaluate the safety and tolerability of treatment with BT063 versus Placebo in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)

A Prospective, Double-blind, Randomized, Placebo-controlled, Repeated dose, Multicentre Phase IIa Proof-of-Concept Study with BT063 in Subjects with Systemic Lupus Erythematosus (BT063 in SLE)

Systemic Lupus Erythematosus
MedDRA version: 19.1;Level: LLT;Classification code 10042947;Term: Systemic lupus erythematosus synd;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: BT063
Product Code: BT063
INN or Proposed INN: BT063
Other descriptive name: BT063

Biotest AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;Belarus;Poland;Georgia

205

EUCTR2015-000372-95-PT
(EUCTR)

11/09/2015

26/06/2015

Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Ablynx N.V.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;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

206

EUCTR2014-004632-19-BE
(EUCTR)

07/09/2015

23/06/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;Germany;Korea, Republic of

207

EUCTR2015-001341-86-BE
(EUCTR)

07/09/2015

03/09/2015

Phase IIb study of IFN-K in Systemic Lupus Erythematosus

Product Name: IFN-Kinoid
Product Code: IFN-K
INN or Proposed INN: Not yet assigned
Other descriptive name: IFN-Kinoid Drug Substance

Neovacs S.A.

NULL

Not Recruiting

Female: yes
Male: yes

178

Phase 2

Serbia;United States;Philippines;Taiwan;Spain;Thailand;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;France;Peru;Tunisia;Moldova, Republic of;Korea, Republic of;Mexico;Argentina;Belgium;Poland;Croatia;Georgia;Bulgaria;Germany

208

EUCTR2014-004633-96-HU
(EUCTR)

02/09/2015

29/06/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

209

NCT02535689
(ClinicalTrials.gov)

August 28, 2015

28/8/2015

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Systemic Lupus Erythematosus; a Phase Ib Clinical Trial and Associated Mechanistic Studies

Systemic Lupus Erythematosus

Drug: Tofacitinib;Drug: Placebo

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NULL

Completed

18 Years

100 Years

All

Phase 1

United States

210

EUCTR2014-004632-19-LT
(EUCTR)

20/08/2015

19/06/2015

A study to evaluate the efficacy and safety of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

360

Phase 3

United States;Spain;Lithuania;Russian Federation;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;South Africa;Bulgaria;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

211

EUCTR2015-000372-95-CZ
(EUCTR)

20/08/2015

16/06/2015

Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000017968;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: vobarilizumab
Other descriptive name: IL-6R nanobody

Ablynx N.V.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru;Germany;Korea, Republic of

212

EUCTR2015-000372-95-ES
(EUCTR)

07/08/2015

10/07/2015

Study Evaluating ALX-0061 Administered Subcutaneously in Patients with Systemic Lupus Erythematosus

Moderate to Severe Active Systemic Lupus Erythematosus
MedDRA version: 18.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ALX-0061 150 mg/mL
INN or Proposed INN: N/A
Other descriptive name: IL-6R nanobody

Ablynx N.V.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

Germany;Korea, Republic of;Serbia;Portugal;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Czech Republic;Hungary;Mexico;Argentina;Poland;Peru

213

EUCTR2014-004633-96-GB
(EUCTR)

16/07/2015

08/05/2015

A study to evaluate the efficacy and safety of two doses of Anifrolumab compared to placebo in adult patients with Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

AstraZeneca AB

NULL

Not Recruiting

Female: yes
Male: yes

450

Phase 3

United States;Taiwan;Ukraine;Chile;Israel;Colombia;United Kingdom;Italy;Hungary;Argentina;Poland;Brazil;Romania;Peru;Australia;Germany;New Zealand;Korea, Republic of

214

NCT02446899
(ClinicalTrials.gov)

July 9, 2015

14/5/2015

Efficacy and Safety of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Biological: Anifrolumab;Drug: Placebo

AstraZeneca

PRA Health Sciences

Completed

18 Years

70 Years

All

373

Phase 3

United States;Argentina;Belgium;Brazil;Bulgaria;Canada;France;Germany;Japan;Korea, Republic of;Lithuania;Mexico;Russian Federation;South Africa;Spain;Czech Republic;Czechia;Singapore

215

NCT02533570
(ClinicalTrials.gov)

July 2015

9/7/2015

Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus

A Multi-center, Randomized, Double-blinded, Placebo-controlled, Multiple-ascending-dose Study of Brentuximab Vedotin in Adults With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Brentuximab vedotin;Drug: Placebo

Seagen Inc.

NULL

Terminated

18 Years

N/A

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

216

NCT02437890
(ClinicalTrials.gov)

July 2015

29/4/2015

A Phase II Study to Evaluate Safety and Efficacy of ALX-0061 in Subjects With Systemic Lupus Erythematosus

A Phase II Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-range Finding Study to Evaluate the Safety and Efficacy of ALX-0061 Administered Subcutaneously in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Biological: ALX-0061;Biological: Placebo

Ablynx

NULL

Completed

18 Years

64 Years

All

312

Phase 2

United States;Argentina;Chile;Czechia;Germany;Hungary;Korea, Republic of;Mexico;Peru;Philippines;Poland;Portugal;Russian Federation;Serbia;Spain;Taiwan;Ukraine;Czech Republic

217

EUCTR2014-005000-19-DE
(EUCTR)

17/06/2015

12/02/2015

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Trade Name: STELARA ®
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 N.V.

NULL

Not Recruiting

Female: yes
Male: yes

134

Phase 2

United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany

218

NCT02446912
(ClinicalTrials.gov)

June 9, 2015

14/5/2015

Efficacy and Safety of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Two Doses of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Biological: Anifrolumab;Drug: Placebo

AstraZeneca

PRA Health Sciences

Completed

18 Years

70 Years

All

460

Phase 3

United States;Argentina;Australia;Brazil;Chile;Colombia;Germany;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Taiwan;Ukraine;United Kingdom

219

EUCTR2014-002984-14-BG
(EUCTR)

05/06/2015

11/05/2015

International clinical trial to evaluate the biological activity and safety of ACT-334441 in lupus

A multicenter, randomized, double-blind, placebo-controlled, dose-response study to investigate the biological activity, safety, tolerability, and pharmacokinetics of ACT-334441 in subjects with systemic lupus erythematosus. -

Systemic lupus erythematosus
;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Code: ACT-334441
Other descriptive name: ACT-334441

ACTELION Pharmaceuticals Ltd

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Belarus;United States;Ukraine;Russian Federation;Georgia;Bulgaria

220

NCT02472795
(ClinicalTrials.gov)

June 1, 2015

14/5/2015

Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-response Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Matching placebo;Drug: Cenerimod

Idorsia Pharmaceuticals Ltd.

NULL

Completed

18 Years

65 Years

All

105

Phase 1;Phase 2

United States;Belarus;Bulgaria;Georgia;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

221

NCT02465580
(ClinicalTrials.gov)

June 2015

3/6/2015

A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: hrIL-2 active;Drug: hrIL-2 placebo

Peking University People's Hospital

Monash University;Beijing SL Pharmaceutical Company Ltd

Recruiting

18 Years

65 Years

Both

Phase 2

China

222

EUCTR2014-005000-19-ES
(EUCTR)

11/05/2015

03/03/2015

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Hungary;Taiwan;Mexico;Argentina;Poland;Spain;Australia;Germany

223

EUCTR2014-005000-19-HU
(EUCTR)

18/03/2015

03/02/2015

A Phase 2a, Efficacy and Safety Study of Ustekinumab in Systemic Lupus Erythematosus

A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 18.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Janssen-Cilag International N.V.

NULL

Not Recruiting

Female: yes
Male: yes

134

Phase 2

United States;Taiwan;Hungary;Mexico;Argentina;Poland;Spain;Australia;Germany

224

NCT02504645
(ClinicalTrials.gov)

March 2015

17/7/2015

Lupus Erythematosus, Systemic

Drug: IPP-201101;Drug: Placebo;Other: Standard of Care

ImmuPharma

NULL

Completed

18 Years

70 Years

All

202

Phase 3

United States;Czechia;France;Germany;Hungary;Mauritius;Poland;Puerto Rico;Czech Republic;Italy

225

EUCTR2014-002184-14-DE
(EUCTR)

26/02/2015

23/12/2014

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus

Active Systemic Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: lulizumab pegol
Product Code: BMS-931699
INN or Proposed INN: lulizumab pegol
Other descriptive name: Anti-CD28dAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;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

226

EUCTR2014-002184-14-IT
(EUCTR)

24/02/2015

09/01/2015

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of BMS-931699 vs. Placebo on a Background of Limited Standard of care in the Treatment of Subjects with Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Lulizumab Pegol
Other descriptive name: Lulizumab Pegol

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of

227

EUCTR2014-002184-14-HU
(EUCTR)

16/02/2015

29/12/2014

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus

Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

United States;Taiwan;Spain;Chile;Colombia;Italy;France;Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of

228

NCT01845740
(ClinicalTrials.gov)

January 2015

17/4/2013

Phase Ib Study of SC Milatuzumab in SLE

A Phase Ib Study of Milatuzumab Administered Subcutaneously in Patients With Active Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic;Lupus Vasculitis, Central Nervous System;Lupus Nephritis

Drug: milatuzumab;Drug: Placebo

Immunomedics, Inc.

Department of Defense

Recruiting

18 Years

N/A

Both

Phase 1;Phase 2

United States

229

EUCTR2014-002184-14-ES
(EUCTR)

26/12/2014

22/12/2014

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythomatosus

Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

350

Phase 2

Hungary;Mexico;Puerto Rico;Canada;Argentina;Poland;Brazil;Romania;South Africa;Netherlands;Germany;Korea, Republic of;France;United States;Taiwan;Spain;Chile;Colombia;Italy

230

NCT02265744
(ClinicalTrials.gov)

November 13, 2014

15/10/2014

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus

Lupus

Drug: BMS-931699;Drug: Placebo matching BMS-931699

Bristol-Myers Squibb

NULL

Completed

18 Years

70 Years

All

730

Phase 2

United States;Argentina;Brazil;Canada;Chile;Colombia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Lebanon;Mexico;Netherlands;Peru;Poland;Puerto Rico;Romania;Russian Federation;South Africa;Spain;Taiwan;Qatar

No.

TrialID

Date_
enrollment

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

NCT02321709
(ClinicalTrials.gov)

November 2014

5/12/2014

Multiple Ascending Dose Study To Assess The Safety Profile Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Systemic Lupus Erythematosus

Drug: SAR113244;Drug: placebo

Sanofi

NULL

Completed

18 Years

75 Years

Both

Phase 1

Germany

232

NCT02185040
(ClinicalTrials.gov)

September 16, 2014

7/7/2014

A Pilot Study of CC-220 to Treat Systemic Lupus Erythematosus.

A Pilot, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study To Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Pharmacogenetics of CC-220 In Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: CC -220;Drug: Placebo

Celgene

NULL

Completed

18 Years

N/A

All

Phase 2

United States

233

NCT02194400
(ClinicalTrials.gov)

July 2014

16/7/2014

Dose Escalation Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus

A Double-Blind, Placebo-Controlled Dose Escalation Study of the Administration of Multiple Intravenous Doses of RSLV-132 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: RSLV-132

Resolve Therapeutics

NULL

Completed

18 Years

70 Years

Both

Phase 1

United States

234

EUCTR2011-005667-25-PL
(EUCTR)

22/05/2014

07/06/2013

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 4

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Norway;New Zealand

235

NCT01956188
(ClinicalTrials.gov)

May 2014

25/9/2013

Omega 3 in LES and APS

Efficacy of EPA and DHA Supplementation in Systemic Lupus Erythematosus and Primary Antiphospholipid Syndrome

Systemic Lupus Erythematosus;Primary Antiphospholipid Syndrome

Dietary Supplement: EPA and DHA supplementation;Dietary Supplement: Placebo

University of Sao Paulo

NULL

Active, not recruiting

20 Years

45 Years

Female

N/A

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

236

NCT02106897
(ClinicalTrials.gov)

April 30, 2014

4/4/2014

Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single Doses and Multiple Doses of BIIB059 in Healthy Volunteers and Participants With Systemic Lupus Erythematosus

A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus;Healthy Volunteers

Drug: BIIB059;Drug: Placebo

Biogen

NULL

Completed

18 Years

N/A

All

109

Phase 1

United States

237

EUCTR2013-002773-21-IT
(EUCTR)

25/03/2014

03/02/2014

Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE) - ADDRESS II

Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

279

Phase 2

United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;Germany;Korea, Republic of

238

EUCTR2013-002773-21-GB
(EUCTR)

03/03/2014

15/01/2014

Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

279

Phase 2

United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of

239

EUCTR2013-002773-21-CZ
(EUCTR)

20/02/2014

11/12/2013

Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

279

Phase 2

United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of

240

EUCTR2013-002773-21-ES
(EUCTR)

20/02/2014

22/01/2014

Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

279

Phase 2

United States;Philippines;Spain;Ukraine;Chile;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Brazil;Poland;Peru;South Africa;Bulgaria;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

241

EUCTR2013-002773-21-DE
(EUCTR)

17/02/2014

07/01/2014

Efficacy and safety study of atacicept in patients with Systemic Lupus Erythematosus (ADDRESS II)

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT
Product Name: Atacicept
INN or Proposed INN: Atacicept
Other descriptive name: ATACICEPT

Merck KGaA

NULL

Not Recruiting

Female: yes
Male: yes

279

Phase 2

United States;Philippines;Spain;Ukraine;Russian Federation;Chile;United Kingdom;Italy;Czech Republic;Mexico;Argentina;Poland;Brazil;Peru;South Africa;Bulgaria;Germany;Korea, Republic of

242

NCT02270957
(ClinicalTrials.gov)

January 2014

13/10/2014

Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches

Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study)

Systemic Lupus Erythematosus

Biological: Abatacept;Other: Placebo

Oklahoma Medical Research Foundation

Bristol-Myers Squibb

Active, not recruiting

18 Years

70 Years

All

Phase 2

United States

243

NCT01972568
(ClinicalTrials.gov)

December 2013

24/10/2013

Efficacy and Safety of Atacicept in Systemic Lupus Erythematosus

A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus, Systemic

Drug: Atacicept 75 milligram (mg);Drug: Atacicept 150 mg;Drug: Placebo

EMD Serono

NULL

Completed

18 Years

N/A

All

306

Phase 2

United States;Argentina;Brazil;Bulgaria;Chile;Czechia;Germany;Italy;Japan;Korea, Republic of;Mexico;Peru;Philippines;Poland;Russian Federation;South Africa;Spain;United Kingdom;Czech Republic;Ukraine

244

EUCTR2011-005667-25-RO
(EUCTR)

21/06/2013

21/07/2014

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5000

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand

245

EUCTR2011-005672-42-GB
(EUCTR)

11/06/2013

27/03/2013

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)

A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE

Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

501

Phase 3;Phase 4

United States;France;Martinique;Brazil;South Africa;Colombia;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

246

EUCTR2011-005667-25-LT
(EUCTR)

10/05/2013

29/11/2012

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 20.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 4

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand

247

EUCTR2011-005667-25-BG
(EUCTR)

24/04/2013

31/01/2013

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 4

United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand

248

EUCTR2011-005667-25-PT
(EUCTR)

05/04/2013

17/01/2013

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 4

Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand;United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada

249

NCT01863641
(ClinicalTrials.gov)

April 2013

17/5/2013

The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

Systemic Lupus Erythematosus

Drug: calcitriol;Drug: placebo

Guilan University of Medical Sciences

NULL

Recruiting

18 Years

65 Years

Both

Phase 2

Iran, Islamic Republic of

250

EUCTR2011-005667-25-SK
(EUCTR)

27/03/2013

05/02/2013

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 4

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;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

251

EUCTR2011-005667-25-IT
(EUCTR)

21/03/2013

14/01/2013

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 15.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB

HUMAN GENOME SCIENCES INC

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5000

Portugal;United States;Philippines;Estonia;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Croatia;Bulgaria;New Zealand

252

NCT01777256
(ClinicalTrials.gov)

March 1, 2013

24/1/2013

An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184

An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: GSK2586184 50 mg;Drug: GSK2586184 100 mg;Drug: GSK2586184 200 mg;Drug: GSK2586184 400 mg;Drug: Placebo

GlaxoSmithKline

NULL

Terminated

18 Years

75 Years

All

Phase 2

Argentina;Chile;Czechia;Estonia;France;Germany;Greece;Hong Kong;Hungary;Korea, Republic of;Peru;Poland;Romania;South Africa;Spain;Sweden;Brazil;Czech Republic

253

NCT01632241
(ClinicalTrials.gov)

February 19, 2013

28/6/2012

Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapy

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

503

Phase 4

United States;Brazil;Colombia;France;South Africa;United Kingdom

254

EUCTR2011-005667-25-ES
(EUCTR)

14/02/2013

21/12/2012

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5000

Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Norway;New Zealand

255

EUCTR2011-000368-88-IT
(EUCTR)

04/02/2013

11/12/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patient 5 to 17 years of age.

A Multi-center, Randomized Parallel Group, Placebo-Controlled Double-Blind Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients with Systemic Lupus Erythematosus (SLE). - Belimumab in pediatric patients with SLE

Systemic lupus erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta (belimumab)
INN or Proposed INN: BELIMUMAB

GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.

NULL

Not Recruiting

Female: yes
Male: yes

100

United States;Mexico;Canada;Argentina;Spain;Brazil;Peru;Netherlands;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

256

NCT01395745
(ClinicalTrials.gov)

February 2013

14/7/2011

CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: blisibimod;Drug: Placebo

Anthera Pharmaceuticals

NULL

Completed

18 Years

N/A

All

442

Phase 3

Belarus;Brazil;Colombia;Georgia;Guatemala;Hong Kong;India;Korea, Republic of;Malaysia;Mexico;Philippines;Russian Federation;Singapore;Sri Lanka;Taiwan;Thailand

257

EUCTR2011-005667-25-CZ
(EUCTR)

30/01/2013

04/12/2012

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5000

Phase 4

258

EUCTR2011-005667-25-HU
(EUCTR)

22/01/2013

22/11/2012

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

5000

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand

259

EUCTR2011-005667-25-EE
(EUCTR)

08/01/2013

12/12/2012

Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

4000

Phase 4

260

NCT01764594
(ClinicalTrials.gov)

January 2013

2/1/2013

Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus

Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease

Biological: CDP7657;Other: Placebo

UCB Pharma

Biogen

Completed

18 Years

75 Years

Both

Phase 1

Belgium;Bulgaria;Germany;Poland;Romania;Russian Federation;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

261

NCT01753401
(ClinicalTrials.gov)

January 2013

17/12/2012

Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease

A Two-part Study Exploring the Efficacy, Safety, and Pharmacodynamics of Acthar in Systemic Lupus Erythematosus Patients With a History of Persistently Active Disease

Systemic Lupus Erythematosus (SLE)

Drug: Acthar;Drug: Placebo;Drug: Steroid Drug

Mallinckrodt

NULL

Completed

18 Years

N/A

All

Phase 4

United States

262

EUCTR2011-000368-88-NL
(EUCTR)

03/12/2012

02/07/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

United States;Mexico;Canada;Argentina;Poland;Brazil;Spain;Peru;Russian Federation;Netherlands;Italy;United Kingdom

263

NCT01705977
(ClinicalTrials.gov)

November 27, 2012

10/10/2012

Belimumab Assessment of Safety in SLE

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

Systemic Lupus Erythematosus

Biological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapy

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Active, not recruiting

18 Years

N/A

All

4019

Phase 4

United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway

264

NCT01686555
(ClinicalTrials.gov)

November 2012

13/9/2012

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-199 in Female Patients With Systemic Lupus Erythematosus (SLE)

Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus

Drug: ABT-199;Other: Placebo

AbbVie (prior sponsor, Abbott)

NULL

Completed

18 Years

65 Years

Female

Phase 1

United States;Germany;Mexico;Puerto Rico

265

NCT01649765
(ClinicalTrials.gov)

September 7, 2012

23/7/2012

Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy

A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: belimumab 10mg/kg;Other: placebo

GlaxoSmithKline

Human Genome Sciences Inc., a GSK Company

Active, not recruiting

5 Years

17 Years

All

Phase 2

United States;Argentina;Canada;Japan;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Brazil;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

266

NCT01689025
(ClinicalTrials.gov)

September 2012

14/9/2012

An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus

Inflammation;Systemic Lupus Erythematosus

Drug: NNC0114-0006;Drug: placebo

Novo Nordisk A/S

NULL

Terminated

18 Years

64 Years

Both

Phase 1

United States;Hungary;Poland;Serbia

267

EUCTR2011-004296-36-CZ
(EUCTR)

29/08/2012

28/06/2012

A study to evaluate the efficacy and safety of MEDI-546 compared to placebo in subjects with Systemic Lupus Erythematosus

A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus

Systemic Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: MEDI-546
Product Code: MEDI-546
INN or Proposed INN: MEDI-546

MedImmune, LLC

,NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 2

United States;Taiwan;Hong Kong;Ukraine;Israel;Colombia;India;Czech Republic;Hungary;Mexico;Poland;Brazil;Romania;Peru;Bulgaria;Korea, Republic of

268

NCT01597050
(ClinicalTrials.gov)

August 2012

9/5/2012

Safety and Efficacy of Topical R333 in Patients With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Lesions

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of R333 6% Ointment Administered Topically to Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) Patients With Active Cutaneous Discoid Lesions

Lupus Erythematosus, Discoid;Lupus Erythematosus, Systemic

Drug: R932333;Drug: Placebo

Rigel Pharmaceuticals

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Canada

269

EUCTR2011-000368-88-ES
(EUCTR)

27/07/2012

21/05/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age.

Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: BENLYSTA? (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline, S.A.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Germany;Netherlands;Italy;Brazil;Russian Federation;United Kingdom;Canada;Peru;Argentina;Mexico;Spain;United States;Poland

270

NCT01892748
(ClinicalTrials.gov)

July 2012

17/6/2013

Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.

Effects of Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Onset Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus

Drug: Cholecalciferol;Drug: Placebo

ROSA MARIA RODRIGUES PEREIRA

NULL

Completed

10 Years

25 Years

Female

N/A

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

271

EUCTR2011-000420-15-DE
(EUCTR)

21/06/2012

06/12/2011

STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Not applicable
Product Code: PF-04236921
INN or Proposed INN: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

180

United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of

272

EUCTR2011-000368-88-GB
(EUCTR)

13/06/2012

18/04/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

100

Phase 2

United States;Mexico;Canada;Argentina;Spain;Poland;Brazil;Peru;Russian Federation;Netherlands;Italy;United Kingdom

273

EUCTR2011-003814-18-PL
(EUCTR)

06/06/2012

19/06/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC

Systemic lupus erythematosis (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

United States;Portugal;Serbia;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden

274

EUCTR2011-003814-18-PT
(EUCTR)

01/06/2012

21/02/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, a wholly owned subsidiary of GlaxoSmithKline, Plc

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

275

NCT01683695
(ClinicalTrials.gov)

June 2012

14/3/2012

Safety Study of AMG 557 in Subjects With Lupus Arthritis

A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis

Lupus Arthritis, Systemic Lupus Erythematosus

Drug: AMG 557;Drug: Matching Placebo

Amgen

NULL

Completed

18 Years

65 Years

All

Phase 1

United States;Australia;Denmark;France;Germany;Malaysia;Taiwan;United Kingdom;Singapore

No.

TrialID

Date_
enrollment

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

EUCTR2010-023396-25-PL
(EUCTR)

30/05/2012

23/09/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled, parallel group, multi-centre clinical trial to investigate the safety, efficacy and pharmacokinetics of recombinant human soluble Fc-gamma receptor IIb (SM101) for intravenous application in the treatment of systemic lupus erythematosus (SLE) patients with or without a history of lupus nephritis - SMILE

Systemic lupus erythematosus (SLE)
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom

277

EUCTR2011-003814-18-BE
(EUCTR)

29/05/2012

01/02/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 15.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

278

EUCTR2011-003814-18-BG
(EUCTR)

22/05/2012

21/05/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

279

EUCTR2011-003814-18-IT
(EUCTR)

15/05/2012

08/06/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
Product Code: NA
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta

HUMAN GENOME SCIENCES INC

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

United States;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;Malaysia;Denmark;Peru;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden

280

EUCTR2011-003814-18-DE
(EUCTR)

03/05/2012

16/12/2011

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 18.0;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;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

281

EUCTR2011-003814-18-ES
(EUCTR)

03/05/2012

29/02/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

282

NCT01687309
(ClinicalTrials.gov)

April 30, 2012

10/5/2012

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2586184 Following a Single Doseof 800mg and Repeat Oral Tablet Doses of 800mg b.d and the Effect of Food and Gender on the Pharmacokinetics of oralGSK2586184 in Healthy Subjects

Systemic Lupus Erythematosus

Drug: GSK2586184 800mg single and repeat dose;Drug: Placebo-to-match GSK2586184;Other: GSK2586184 single dose taken with food;Other: GSK2586184 single dose taken without food

GlaxoSmithKline

NULL

Completed

18 Years

65 Years

All

Phase 1

Belgium

283

EUCTR2011-003814-18-GB
(EUCTR)

12/04/2012

19/04/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Human Genome Sciences, Inc. (a wholy owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

284

EUCTR2010-018563-41-EE
(EUCTR)

09/04/2012

09/03/2012

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1) - EMBODY 1

Systemic Lupus Erythmatosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of

285

EUCTR2011-003814-18-SE
(EUCTR)

28/03/2012

31/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

United States;Serbia;Portugal;Philippines;Taiwan;Thailand;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;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

286

EUCTR2011-003814-18-CZ
(EUCTR)

27/03/2012

25/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

287

EUCTR2010-018563-41-LT
(EUCTR)

14/03/2012

14/02/2012

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of

288

EUCTR2011-003814-18-DK
(EUCTR)

08/03/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

289

EUCTR2011-003814-18-HU
(EUCTR)

08/03/2012

18/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Peru;Denmark;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden

290

NCT01551069
(ClinicalTrials.gov)

March 2012

8/3/2012

Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion

A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion

Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Drug: hydroxychloroquine (Z0188);Drug: Placebo

Sanofi

NULL

Completed

18 Years

N/A

Both

103

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

291

EUCTR2010-023396-25-NL
(EUCTR)

16/02/2012

24/10/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

France;Czech Republic;Belgium;Spain;Poland;Australia;Germany;Netherlands;Italy;United Kingdom

292

EUCTR2011-000420-15-HU
(EUCTR)

08/02/2012

15/12/2011

STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF 04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) - Butterfly

SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Product Name: Not applicable
Product Code: PF-04236921
INN or Proposed INN: Not applicable

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

NULL

Not Recruiting

Female: yes
Male: yes

180

United States;Taiwan;Lithuania;Chile;Israel;Colombia;India;Hungary;Mexico;Argentina;Poland;Romania;Peru;Germany;Moldova, Republic of;Korea, Republic of

293

EUCTR2011-003814-18-AT
(EUCTR)

01/02/2012

23/01/2012

A Study of Belimumab Administered Subcutaneously in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic lupus erythematosis (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Belimumab
INN or Proposed INN: Belimumab
Other descriptive name: Benlysta

Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)

NULL

Not Recruiting

Female: yes
Male: yes

816

Phase 3

294

NCT01440231
(ClinicalTrials.gov)

February 2012

22/9/2011

Atacicept Demonstrating Dose RESponSe

A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Dose-Response Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Atacicept

EMD Serono

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

United States

295

NCT01488708
(ClinicalTrials.gov)

January 2012

6/12/2011

On Open-Label Study in Participants With Systemic Lupus Erythematosus

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)

Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease

Drug: LY2127399;Drug: Placebo

Eli Lilly and Company

NULL

Terminated

18 Years

N/A

All

1518

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

296

NCT01438489
(ClinicalTrials.gov)

January 2012

9/9/2011

A Study of the Efficacy and Safety of MEDI-546 in Systemic Lupus Erythematosus

A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: Anifrolumab 300 mg;Biological: Anifrolumab 1000 mg;Other: Placebo

MedImmune LLC

NULL

Completed

18 Years

65 Years

All

626

Phase 2

United States;Brazil;Bulgaria;Colombia;Czech Republic;Hungary;India;Korea, Republic of;Mexico;Peru;Poland;Romania;Taiwan;Ukraine;Hong Kong

297

NCT01405196
(ClinicalTrials.gov)

December 2011

27/7/2011

Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)

Lupus Erythematosus, Systemic

Biological: PF-04236921

Pfizer

NULL

Completed

18 Years

75 Years

All

183

Phase 2

United States;Argentina;Chile;Colombia;Germany;Hungary;Korea, Republic of;Moldova, Republic of;Peru;Poland;Puerto Rico;Romania;Taiwan;Mexico

298

NCT01484496
(ClinicalTrials.gov)

November 16, 2011

28/11/2011

A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Biological: Placebo;Biological: Belimumab 200 mg SC;Drug: Standard therapy

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

All

839

Phase 3

United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Croatia;Czechia;Denmark;France;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Spain;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Czech Republic

299

EUCTR2010-023396-25-DE
(EUCTR)

09/11/2011

14/06/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom

300

EUCTR2010-023396-25-CZ
(EUCTR)

13/10/2011

01/08/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

France;Czech Republic;Belgium;Spain;Poland;Australia;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

301

NCT01449071
(ClinicalTrials.gov)

October 2011

3/10/2011

Study Evaluating the Pharmacokinetics and Safety of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE)

A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease

Systemic Lupus Erythematosus

Biological: Placebo;Biological: Epratuzumab 400 mg;Biological: Epratuzumab 1200 mg;Biological: Epratuzumab 100 mg;Biological: Epratuzumab 600 mg

UCB Pharma

NULL

Completed

18 Years

64 Years

Both

Phase 1;Phase 2

Japan

302

EUCTR2010-023396-25-GB
(EUCTR)

22/09/2011

11/04/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
INN or Proposed INN: .
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Belgium;Spain;Poland;Australia;Netherlands;Germany;Italy;United Kingdom

303

EUCTR2010-023396-25-ES
(EUCTR)

20/09/2011

11/11/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Ensayo clínico multicéntrico, de grupos paralelos, controlado por placebo, doble ciego, randomizado 2:2:1, de fase IIa, para investigar la seguridad, eficacia y farmacocinética del receptor Fc-gamma IIb recombinante, humano, soluble (SM101) para su aplicación intravenosa en el tratamiento de pacientes con lupus eritematoso sistémico (LES) con o sin un historial de nefritis lúpica - SMILE

lupus eritematoso sistémico (LES)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Poland;Australia

304

EUCTR2010-018565-26-IT
(EUCTR)

15/09/2011

05/01/2012

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF FOUR 12-WEEK TREATMENT CYCLES (48 WEEKS TOTAL) OF EPRATUZUMAB IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS WITH MODERATE TO SEVERE DISEASE (EMBODY 2) - EMBODY 2

Systemic Lupus Erythmatosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;United Kingdom;Italy;India

305

EUCTR2010-018563-41-BG
(EUCTR)

02/09/2011

25/07/2011

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;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

306

EUCTR2010-023396-25-BE
(EUCTR)

13/07/2011

20/04/2011

A study to assess the safety and effectiveness of SL101 in the treatment of systemic lupus erythematosus (SLE)

Phase IIa, 2:2:1 randomised, double-blind, placebo-controlled,parallel group, multi-centre clinical trial toinvestigate the safety, efficacy and pharmacokinetics ofrecombinant human soluble Fc-gamma receptor IIb(SM101) for intravenous application in the treatment ofsystemic lupus erythematosus (SLE) patients with orwithout a history of lupus nephritis - SMILE

Systemic lupus erythematosus (SLE)
MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Product Name: soluble Fc-gamma receptor IIb
Product Code: SM101
Other descriptive name: soluble Fc receptor

SuppreMol GmbH

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Czech Republic;Spain;Poland;Belgium;Australia;Netherlands;Germany;Italy;United Kingdom

307

EUCTR2010-022099-29-DE
(EUCTR)

04/07/2011

14/12/2010

Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1

Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Canada;Macedonia, the former Yugoslav Republic of;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of

308

EUCTR2010-018563-41-IT
(EUCTR)

23/06/2011

20/03/2012

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: EPRATUZUMAB

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Russian Federation;Israel;United Kingdom;Italy;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of

309

EUCTR2010-018565-26-DE
(EUCTR)

21/06/2011

21/01/2011

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India

310

EUCTR2010-018563-41-DE
(EUCTR)

21/06/2011

21/01/2011

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;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

311

EUCTR2010-022099-29-BG
(EUCTR)

16/06/2011

24/02/2011

Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).

Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

United States;Belarus;Philippines;Thailand;Guatemala;Ukraine;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of

312

EUCTR2010-018563-41-BE
(EUCTR)

25/05/2011

19/11/2010

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Belgium;Brazil;Australia;Bulgaria;Germany;Korea, Republic of

313

NCT01345253
(ClinicalTrials.gov)

May 23, 2011

28/4/2011

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Systemic Lupus Erythematosus

Drug: Belimumab;Drug: Placebo

GlaxoSmithKline

Human Genome Sciences Inc.

Completed

18 Years

N/A

All

709

Phase 3

China;Japan;Korea, Republic of

314

EUCTR2010-018565-26-GB
(EUCTR)

13/05/2011

09/02/2011

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythmatosus
MedDRA version: 16.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Hungary;Mexico;Canada;Spain;Brazil;Ukraine;South Africa;Russian Federation;Germany;Italy;United Kingdom;India

315

EUCTR2010-018563-41-GB
(EUCTR)

13/05/2011

09/02/2011

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythmatosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;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

316

NCT01858792
(ClinicalTrials.gov)

May 2011

19/12/2012

A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

Efficacy and Safety of Belimumab in a Subgroup of Systemic Lupus Erythematosus (SLE) Patients With Higher Disease Activity (Anti-dsDNA Positive and Low Complement): A Pooled Analysis of the HGS1006-C1056 (BLISS-52) and HGS1006-C1057 (BLISS-76) Studies

Lupus Erythematosus, Discoid

Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Other: Placebo

Human Genome Sciences Inc., a GSK Company

GlaxoSmithKline

Completed

18 Years

N/A

Both

N/A

NULL

317

EUCTR2010-022100-42-GB
(EUCTR)

28/04/2011

19/01/2011

Not available

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

United States;Serbia;Taiwan;Ecuador;Spain;Russian Federation;Israel;United Kingdom;India;France;Hungary;Mexico;Canada;Brazil;Malaysia;Romania;Australia;South Africa;Tunisia;Latvia;New Zealand

318

EUCTR2010-022100-42-ES
(EUCTR)

20/04/2011

15/02/2011

Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE)

Lupus Eritematoso Sistémico (LES) //Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: Anti LP40 anticuerpo, subclase IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

Hungary;Spain;Latvia;United Kingdom

319

EUCTR2010-022100-42-LV
(EUCTR)

08/04/2011

13/01/2011

Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand

320

NCT01283139
(ClinicalTrials.gov)

March 31, 2011

20/1/2011

A Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: Sifalimumab 200 mg;Biological: Sifalimumab 600 mg;Biological: Sifalimumab 1,200 mg;Other: Placebo

MedImmune LLC

NULL

Completed

18 Years

75 Years

All

834

Phase 2

United States;Argentina;Brazil;Bulgaria;Canada;Chile;France;Germany;Hungary;India;Italy;Jamaica;Mexico;Netherlands;Peru;Philippines;Poland;Romania;South Africa;Spain;Thailand;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

321

EUCTR2010-018563-41-CZ
(EUCTR)

25/02/2011

26/01/2011

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Taiwan;Spain;Lithuania;Israel;Russian Federation;Italy;United Kingdom;India;Czech Republic;Mexico;Brazil;Belgium;Australia;Bulgaria;Germany;Korea, Republic of

322

EUCTR2010-022100-42-HU
(EUCTR)

23/02/2011

13/01/2011

Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand

323

EUCTR2010-018565-26-ES
(EUCTR)

22/02/2011

23/12/2010

Estudio en fase III, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY2). - EMBODY 2

Lupus Sistémico Eritematoso
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Hungary;Spain;Germany;Italy;United Kingdom

324

EUCTR2010-018563-41-ES
(EUCTR)

21/02/2011

22/12/2010

Estudio en fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico sobre la eficacia y la seguridad de cuatro ciclos de tratamiento de 12 semanas (48 semanas) con epratuzumab en pacientes con lupus eritematoso sistémico moderado a intenso (EMBODY 1). //A phase 3, randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus erythematosus subjects with moderate to severe disease (EMBODY 1). - EMBODY 1

Lupus eritematoso sistémico
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Estonia;Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom

325

EUCTR2010-022099-29-AT
(EUCTR)

27/01/2011

28/12/2010

Study investigating a new medicine, LY2127399, in patients diagnosedwith Systemic Lupus Erythematosus (SLE).

Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4

Eli Lilly and Company

NULL

Not Recruiting

Female: yes
Male: yes

1140

Phase 3

United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;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

326

EUCTR2010-018565-26-HU
(EUCTR)

16/01/2011

22/11/2010

Study of Epratuzumab versus Placebo in subjects with moderate to severe general Systemic Lupus Erythematosus (SLE)

Product Name: Epratuzumab
Product Code: CDP3194
INN or Proposed INN: Epratuzumab

UCB Inc.

NULL

Not Recruiting

Female: yes
Male: yes

780

Phase 3

Hungary;Mexico;Canada;Spain;Brazil;Ukraine;Russian Federation;South Africa;Germany;Italy;United Kingdom;India

327

NCT01217320
(ClinicalTrials.gov)

January 2011

6/10/2010

Creatine Supplementation in Pediatric Rheumatology

Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis

Juvenile Systemic Lupus Erythematosus;Juvenile Dermatomyositis

Dietary Supplement: creatine;Dietary Supplement: placebo (dextrose)

University of Sao Paulo

NULL

Recruiting

6 Years

18 Years

Both

N/A

Brazil

328

NCT01205438
(ClinicalTrials.gov)

January 2011

17/9/2010

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease

Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

1124

Phase 3

United States;Australia;Brazil;Canada;Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom

329

NCT01276782
(ClinicalTrials.gov)

January 2011

12/1/2011

Levothyroxine in Pregnant SLE Patients

Pilot Double-Blind Placebo Controlled Trial of Levothyroxine in Pregnant Systemic Lupus Erythematosus (SLE) Patients With Autoimmune Thyroid Disease

Systemic Lupus Erythematosus

Drug: Levothyroxine

Johns Hopkins University

New York University School of Medicine;Duke University;University of Chicago;Stanford University

Withdrawn

18 Years

45 Years

Female

Phase 4

United States

330

NCT01262365
(ClinicalTrials.gov)

December 2010

14/12/2010

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

Systemic Lupus Erythematosus

Drug: Epratuzumab;Drug: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

All

793

Phase 3

United States;Australia;Belgium;Brazil;Bulgaria;Czechia;Estonia;France;Germany;India;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Puerto Rico;Romania;Russian Federation;Spain;Taiwan;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

331

NCT01261793
(ClinicalTrials.gov)

December 2010

14/12/2010

Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Epratuzumab

UCB Pharma

NULL

Completed

18 Years

N/A

All

791

Phase 3

United States;Brazil;Canada;France;Germany;Hungary;India;Italy;Mexico;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Netherlands

332

NCT01196091
(ClinicalTrials.gov)

December 2010

3/9/2010

A Study of LY2127399 in Participants With Systemic Lupus Erythematosus

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune Disease

Drug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks;Drug: Standard of Care

Eli Lilly and Company

NULL

Completed

18 Years

N/A

All

1164

Phase 3

United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey

333

EUCTR2010-018383-16-BE
(EUCTR)

10/11/2010

19/07/2010

A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 2

France;United States;Portugal;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Germany

334

EUCTR2010-018383-16-PT
(EUCTR)

01/10/2010

23/07/2010

A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 13.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany

335

EUCTR2010-018383-16-DE
(EUCTR)

17/09/2010

16/07/2010

A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

United States;Portugal;France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;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

336

EUCTR2010-018383-16-HU
(EUCTR)

16/08/2010

20/07/2010

A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Portugal;Hungary;Germany;Czech Republic;Ukraine;Belgium;France;Spain;United States;Poland

337

EUCTR2010-018383-16-CZ
(EUCTR)

13/08/2010

22/07/2010

A clinical study to evaluate the effectiveness and tolerability of a 200mcg dose of CEP-33457 in patients with a chronic autoimmune disease (Lupus).

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: Forigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

France;United States;Portugal;Hungary;Czech Republic;Belgium;Spain;Poland;Ukraine;Germany

338

EUCTR2009-012059-47-DE
(EUCTR)

12/08/2010

21/01/2010

A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

France;Belgium;Bulgaria;Germany

339

EUCTR2010-018383-16-ES
(EUCTR)

10/08/2010

20/07/2010

Estudio aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de una dosis de 200 µg de CEP-33457 en pacientes con lupus eritematoso sistémico.A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Pacientes con lupus eritematoso sistémico (LES). Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 13;Level: LLT;Classification code 10042945;Term: Lupus eritematoso sistémico

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Portugal;Hungary;Czech Republic;Germany;France;Spain

340

EUCTR2010-018383-16-FR
(EUCTR)

05/08/2010

29/07/2010

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus - Celestial 47

Patients With Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Lupuzor
Product Code: CEP-33457
INN or Proposed INN: rigerimod
Other descriptive name: IPP-201101, P140

Cephalon, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Portugal;Hungary;Czech Republic;Germany;France;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

341

NCT01164917
(ClinicalTrials.gov)

August 2010

15/7/2010

Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in Subjects With Discoid Lupus Erythematosus

Cutaneous Lupus;Discoid Lupus;Lupus;Systemic Lupus Erythematosus

Drug: AMG811;Drug: AMG811 Placebo

Amgen

NULL

Terminated

18 Years

70 Years

Both

Phase 1

United States

342

NCT01381536
(ClinicalTrials.gov)

July 20, 2010

21/4/2011

Phase I Study of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)

GSK1550188, A Randomised, Single-blind, Placebo Controlled, Dose Ascending, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic of GSK1550188 in Japanese Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: GSK1550188 1mg/kg or 10mg/kg

GlaxoSmithKline

NULL

Completed

20 Years

N/A

All

Phase 1

Japan

343

NCT01085084
(ClinicalTrials.gov)

July 2010

9/3/2010

Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Arthritis

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients With Active Lupus Arthritis

Lupus Arthritis

Drug: Laquinimod;Other: Placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

75 Years

Both

Phase 2

United States;Canada

344

NCT01162681
(ClinicalTrials.gov)

July 2010

13/7/2010

PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: A-623;Other: Placebo Comparator

Anthera Pharmaceuticals

NULL

Completed

18 Years

N/A

Both

547

Phase 2

United States;Argentina;Brazil;Chile;Colombia;Hong Kong;India;Mexico;Peru;Philippines;Taiwan

345

NCT01085097
(ClinicalTrials.gov)

July 2010

4/3/2010

Laquinimod Study in Systemic Lupus Erythematosus (SLE) Patients With Active Lupus Nephritis

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination With Standard of Care (Mycophenolate Mofetil and Steroids)

Lupus Nephritis

Drug: laquinimod;Drug: Mycophenolate Mofetil;Drug: prednisolone /prednisone;Drug: Placebo

Teva Pharmaceutical Industries

NULL

Completed

18 Years

75 Years

Both

Phase 2

United States;Canada;France;Russian Federation;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

346

NCT01170585
(ClinicalTrials.gov)

July 2010

26/7/2010

A Trial of Rosuvastatin in Systemic Lupus Erythematosus

A Randomised Placebo Controlled Trial of Rosuvastatin in Systemic Lupus Erythematosus

Atherosclerosis;Systemic Lupus Erythematosus

Drug: Rosuvastatin;Drug: Placebo

Imperial College London

NULL

Completed

18 Years

80 Years

Both

Phase 2

United Kingdom

347

NCT01135459
(ClinicalTrials.gov)

June 2010

1/6/2010

A Study to Evaluate the Efficacy and Safety of CEP-33457 in Patients With Systemic Lupus Erythematosus

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of CEP-33457 in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Lupuzor;Drug: Placebo

Cephalon

NULL

Completed

18 Years

70 Years

Both

183

Phase 2

United States;Belgium;Czech Republic;France;Germany;Hungary;Poland;Portugal;Spain;Ukraine;United Kingdom

348

EUCTR2009-012059-47-FR
(EUCTR)

07/05/2010

02/02/2010

A phase I-II, randomized, observer-blind, placebo-controlled, dose escalation study to evaluate the safety and immune responses of various doses of Neovacs’ IFNa-Kinoid in adult patients with Systemic Lupus Erythematosus. - IFN-Kinoid in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

France;Belgium;Bulgaria;Germany

349

NCT01127321
(ClinicalTrials.gov)

May 2010

14/4/2010

A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus

A Phase 1, Double-blind, Randomized, Single Ascending Dose Study of the Safety and Tolerability of MEDI-570 in SLE

Lupus Erythematosus, Systemic

Other: Placebo;Biological: MEDI-570 0.03 MG;Biological: MEDI-570 0.1 MG;Biological: MEDI-570 0.3 MG;Biological: MEDI-570 1 MG

MedImmune LLC

AstraZeneca

Terminated

18 Years

N/A

All

Phase 1

United States;Canada;Mexico;Peru;South Africa

350

EUCTR2009-012059-47-BG
(EUCTR)

23/04/2010

15/04/2010

A phase I-II, randomized, double-blind, placebo-controlled, dose escalation study of Neovacs’ IFNa-Kinoid in adult subjects with Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

France;Belgium;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

351

NCT01425775
(ClinicalTrials.gov)

April 2010

18/8/2011

The Effect of Vitamin D Supplementation on Disease Activity Markers in Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: vitamin D 25(OH)D;Other: Placebo

Faculty of Medicine, University of Alexandria

NULL

Completed

18 Years

60 Years

Both

248

N/A

Egypt

352

NCT01058343
(ClinicalTrials.gov)

March 2010

27/1/2010

Safety of IFNa Kinoid in Systemic Lupus Erythematosus

A Phase I-II, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study of Neovacs' IFNa-Kinoid in Adult Subjects With Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus

Biological: IFN-K

Neovacs

NULL

Completed

18 Years

50 Years

All

Phase 1;Phase 2

Belgium;Bulgaria;Croatia;France;Germany;Switzerland;Romania;Spain

353

NCT01093911
(ClinicalTrials.gov)

March 2010

12/3/2010

Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.

Immune System Diseases;Autoimmune Diseases;Lupus Erythematosus, Systemic;Skin and Connective Tissue Diseases;Connective Tissue Disease

Biological: CDP7657;Other: Placebo

UCB Pharma

NULL

Completed

18 Years

60 Years

Both

Phase 1

Belgium;Bulgaria;Germany

354

EUCTR2006-006214-16-GB
(EUCTR)

23/02/2010

29/02/2008

A randomised placebo controlled trial of rosuvastatin in systemic lupus erythematosus. - RCT of statin in SLE

Systemic lupus erythematosus.
MedDRA version: 13.1;Level: LLT;Classification code 10042944;Term: Systemic lupus erythematosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Imperial College

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom

355

EUCTR2009-012059-47-BE
(EUCTR)

28/01/2010

05/01/2010

Product Name: IFN-a2b Kinoid
Product Code: IFN-K
INN or Proposed INN: Not assigned yet
Other descriptive name: IFN-a 2b Kinoid Drug Substance

Neovacs SA

NULL

Not Recruiting

Female: yes
Male: yes

Phase 1;Phase 2

France;Belgium;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

356

NCT01018238
(ClinicalTrials.gov)

November 2009

16/11/2009

An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)

A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)

Inflammation;Systemic Lupus Erythematosus

Drug: NNC 0151-0000-0000;Drug: placebo

Novo Nordisk A/S

NULL

Withdrawn

18 Years

65 Years

Both

Phase 1

United States

357

NCT00962832
(ClinicalTrials.gov)

September 2009

19/8/2009

A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) in Patients With Moderately to Severely Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Rontalizumab

Genentech, Inc.

NULL

Completed

18 Years

65 Years

Both

238

Phase 2

United States;Argentina;Colombia;Mexico;Poland;Russian Federation;United Kingdom

358

NCT01914770
(ClinicalTrials.gov)

July 2009

3/4/2012

Effectiveness of Belimumab Treatment in a Subpopulation of Systemic Lupus Erythematosus (SLE) Patients: a Pooled Analysis of BLISS-52 and BLISS-76

Systemic Lupus Erythematosus

Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg;Drug: Placebo

GlaxoSmithKline

Human Genome Sciences Inc.

Completed

18 Years

N/A

Both

1016

N/A

NULL

359

NCT00960362
(ClinicalTrials.gov)

July 2009

14/8/2009

An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)

A Randomised, Double-blind, Placebo-controlled, and Single Dose-escalation Trial of AGS-009 Administered in Subjects With Systemic Lupus Erythematosus

Inflammation;Systemic Lupus Erythematosus (SLE)

Drug: AGS-009;Drug: placebo

Argos Therapeutics

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States;Sweden

360

NCT00976729
(ClinicalTrials.gov)

May 2009

11/9/2009

NOX-E36 First-in-Human (FIH) Study

NOX-E36 - A Phase I, Double-Blind, Placebo Controlled, Single Intravenous and Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects

Chronic Inflammatory Diseases;Type 2 Diabetes Mellitus;Systemic Lupus Erythematosus

Drug: NOX-E36;Drug: Placebo

NOXXON Pharma AG

NULL

Completed

18 Years

60 Years

Both

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

361

EUCTR2007-003621-24-AT
(EUCTR)

30/03/2009

23/04/2008

Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension.

Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

362

NCT00818948
(ClinicalTrials.gov)

March 2009

18/12/2008

Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

Nephritis;Systemic Lupus Erythematosus

Drug: AMG 811

Amgen

NULL

Completed

18 Years

70 Years

Both

Phase 1

United States;France;Hong Kong;Malaysia;Mexico;Singapore

363

NCT00828178
(ClinicalTrials.gov)

February 2009

22/1/2009

Efficacy of Fish Oil in Lupus Patients

A Randomized, Double-blind, Placebo-controlled, Clinical Trial of Omega-3-polyunsaturated Fatty Acids in Subjects With SLE.

Systemic Lupus Erythematosus

Drug: Omega-3;Device: flow-mediated dilation of the brachial artery;Other: corn starch

Michelle Petri M.D.,MPH

NULL

Completed

18 Years

N/A

All

106

Phase 4

United States

364

EUCTR2007-003621-24-GB
(EUCTR)

02/12/2008

14/07/2008

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom

365

NCT00774943
(ClinicalTrials.gov)

December 2008

16/10/2008

A Study of AMG 557 in Adults With Systemic Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled, Ascending, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: AMG 557

Amgen

NULL

Completed

18 Years

70 Years

Both

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

366

NCT00752999
(ClinicalTrials.gov)

November 2008

15/9/2008

Efficacy and Safety Study of R935788 Tablets to Treat Systemic Lupus Erythematosus

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Dose Study of R935788 in Systemic Lupus Erythematosus Patients With Active Disease

Systemic Lupus Erythematosus

Drug: Fostamatinib Disodium (R935788);Drug: Placebo

Rigel Pharmaceuticals

NULL

Withdrawn

18 Years

N/A

Both

Phase 2

NULL

367

NCT00710021
(ClinicalTrials.gov)

November 2008

1/7/2008

Vitamin D3 in Systemic Lupus Erythematosus

Effect of Vitamin D3 on the IFN Alpha Signature in Patients With Systemic Lupus Erythematosus (ALE02)

Systemic Lupus Erythematosus;SLE;Lupus

Drug: Vitamin D3;Drug: Vitamin D3 placebo

National Institute of Allergy and Infectious Diseases (NIAID)

Autoimmunity Centers of Excellence

Completed

18 Years

N/A

All

Phase 2

United States

368

EUCTR2007-003698-13-BG
(EUCTR)

29/09/2008

07/08/2008

A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III

Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5
Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono International

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom

369

EUCTR2007-003698-13-LV
(EUCTR)

15/09/2008

19/06/2008

Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania

370

EUCTR2007-003698-13-GR
(EUCTR)

09/09/2008

29/10/2009

Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;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

371

EUCTR2006-000674-73-BG
(EUCTR)

14/08/2008

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus Sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium
Other descriptive name: RIQUENT

La Jolla Pharmaceutical Company

NULL

Not Recruiting

Female: yes
Male: yes

730

Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy

372

EUCTR2007-003621-24-NL
(EUCTR)

23/07/2008

13/03/2008

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

373

EUCTR2007-003621-24-IT
(EUCTR)

15/07/2008

17/11/2008

Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD).
MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil

MONDOGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

374

NCT00657189
(ClinicalTrials.gov)

July 2008

9/4/2008

A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus

A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic;Lupus

Drug: MEDI-545;Drug: Placebo

MedImmune LLC

NULL

Completed

18 Years

N/A

Both

Phase 2

United States

375

EUCTR2007-003621-24-BE
(EUCTR)

20/06/2008

08/01/2008

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

France;Spain;Belgium;Austria;Germany;Netherlands;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

376

EUCTR2006-005357-29-BG
(EUCTR)

18/06/2008

17/04/2008

Clinical trial to study a drug in people with kidney disease related to lupus

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG

Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis
MedDRA version: 15.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden

377

EUCTR2007-002566-35-HU
(EUCTR)

09/06/2008

28/01/2008

A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007

systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2b

Hungary;United Kingdom;Belgium;Spain;Lithuania

378

NCT02151409
(ClinicalTrials.gov)

June 2008

28/5/2014

Dose-escalation Trial of Anti-C5aR Antibody in Healthy Subjects

A Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Trial of Anti-C5aR Antibody (NNC 0151-0000-0000) Administered by i.v. Infusion or s.c. Injection in Healthy Subjects.

Inflammation;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Healthy

Drug: NNC 0151-0000-0000;Drug: placebo

Novo Nordisk A/S

NULL

Completed

18 Years

55 Years

Male

Phase 1

Netherlands

379

EUCTR2007-003621-24-FR
(EUCTR)

29/05/2008

27/12/2007

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria

380

EUCTR2007-003698-13-LT
(EUCTR)

14/05/2008

13/03/2008

Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

Serbia;United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;Switzerland;India;France;Malaysia;Peru;Australia;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;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

381

EUCTR2006-000674-73-IT
(EUCTR)

12/05/2008

20/03/2008

A randomized, double-blind, placebo-controlled, three-arm, parallel-group, multicenter, multinational, safety and efficacy trial of 300 mg and 900 mg of Abetimus sodium in Systemic Lupus Erythematosus (SLE) patients with a history of renal disease - ND

Systemic lupus erithematosus (SLE) patients with a history of renal disease.
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus

LA JOLLA PHARMACEUTICAL COMPANY

NULL

Not Recruiting

Female: yes
Male: yes

730

Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy

382

EUCTR2007-003698-13-ES
(EUCTR)

09/05/2008

12/02/2008

Estudio randomizado, doble ciego, controlado frente a placebo, prospectivo, multicéntrico, de búsqueda de dosis, en fase II/III, con atacicept subcutáneo en sujetos que recientemente han experimentado un brote de Lupus eritematoso sistémico.A randomised, double-blind, placebo-controlled, multicentre prospective dose-finding Phase II/III study with atacicept given subcutaneously to subjects having recently experienced a flare of systemic lupus erythematosus (SLE) - Atacicept in generalised SLE Phase II/III

Lupus Eritematoso Sistémico Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

510

Phase 2;Phase 3

Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania

383

EUCTR2006-005355-16-GB
(EUCTR)

07/05/2008

16/08/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

423

Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden

384

EUCTR2006-005357-29-GB
(EUCTR)

07/05/2008

16/08/2007

Lupus Nephritis

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Phase 3

Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden

385

NCT00611663
(ClinicalTrials.gov)

May 2008

28/1/2008

Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus

VACCILUP A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Biological: Prevenar® and Pneumo23®;Biological: Placebo, Pneumo23®

Assistance Publique - Hôpitaux de Paris

NULL

Completed

18 Years

65 Years

Both

Phase 2;Phase 3

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

386

EUCTR2007-003698-13-AT
(EUCTR)

30/04/2008

10/03/2008

Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono SA - Geneva

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

France;Czech Republic;Greece;Spain;Lithuania;Austria;Bulgaria;Latvia;Germany;Netherlands;United Kingdom

387

EUCTR2007-004892-21-BG
(EUCTR)

16/04/2008

15/04/2008

A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety, Tolerability and Efficacy of Two Doses of Subcutaneous IPP-201101 Plus Standard of Care, Versus Placebo Plus Standard of Care in Subjects with Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: HLT;Classification code 10025135;Term: Lupus erythematosus (incl subtypes)

Product Code: IPP-201101
INN or Proposed INN: IPP - 201101
Other descriptive name: P 140

IMMUPHARMA SA

NULL

Not Recruiting

Female: yes
Male: yes

296

Phase 2b

Bulgaria;Spain

388

EUCTR2006-005355-16-SE
(EUCTR)

10/04/2008

21/12/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

423

Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden

389

EUCTR2007-003698-13-CZ
(EUCTR)

09/04/2008

06/02/2008

Atacicept phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

United States;Philippines;Taiwan;Greece;Spain;Lebanon;Israel;Chile;India;France;Malaysia;Australia;Peru;Netherlands;Latvia;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany

390

EUCTR2006-005355-16-PL
(EUCTR)

04/04/2008

03/01/2008

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;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

391

EUCTR2007-003698-13-NL
(EUCTR)

01/04/2008

08/01/2008

Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

392

EUCTR2006-005355-16-DE
(EUCTR)

25/03/2008

01/10/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

423

Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Poland;Sweden

393

EUCTR2007-003621-24-DE
(EUCTR)

20/03/2008

13/02/2009

Product Name: Aviptadil
Product Code: VIP
INN or Proposed INN: Aviptadil
Other descriptive name: VIP

MondoGEN AG

NULL

Not Recruiting

Female: yes
Male: yes

United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria

394

EUCTR2007-002566-35-GB
(EUCTR)

19/03/2008

29/11/2007

systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2b

Hungary;United Kingdom;Belgium;Spain;Lithuania

395

EUCTR2005-004575-37-GB
(EUCTR)

14/03/2008

08/10/2008

A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE). Revised Protocol 03, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Protocol Amendment 07 (V1.0, dated 17-Apr-2008), and Protocol Amendment 11 (V1.0, dated 11-Dec-2008). + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).

IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic

Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 2;Phase 3

France;Belgium;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

396

EUCTR2006-005355-16-PT
(EUCTR)

07/03/2008

23/11/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

423

Hungary;Portugal;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden

397

EUCTR2006-005357-29-PT
(EUCTR)

07/03/2008

23/11/2007

Lupus Nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Hungary;Portugal;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden

398

EUCTR2007-003698-13-GB
(EUCTR)

06/03/2008

13/12/2007

Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)

Systemic Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3

United States;Serbia;Philippines;Taiwan;Greece;Spain;Lebanon;Chile;Israel;Switzerland;India;France;Malaysia;Australia;Peru;Latvia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Argentina;Brazil;Croatia;Bulgaria;Germany

399

EUCTR2007-003698-13-FR
(EUCTR)

04/03/2008

28/01/2008

Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono International SA, An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

510

Phase 2;Phase 3

Germany;Czech Republic;United Kingdom;Netherlands;Bulgaria;France;Spain;Greece;Latvia;Austria;Lithuania

400

EUCTR2007-002566-35-BE
(EUCTR)

25/02/2008

03/12/2007

systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2b

Hungary;United Kingdom;Belgium;Spain;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

401

EUCTR2006-005355-16-NL
(EUCTR)

22/02/2008

22/11/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

423

Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden

402

EUCTR2006-005357-29-NL
(EUCTR)

22/02/2008

22/11/2007

Lupus Nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

369

Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden

403

EUCTR2006-000674-73-ES
(EUCTR)

21/02/2008

03/12/2007

ESTUDIO ALEATORIZADO, A DOBLE CIEGO, CONTROLADO CON PLACEBO, DE TRES BRAZOS, GRUPOS PARALELOS, MULTICÉNTRICO Y MULTINACIONAL SOBRE LA SEGURIDAD Y EFICACIA DE 300 MG Y 900 MG DE ABETIMUS SÓDICO EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO (LES) CON ANTECEDENTES DE NEFROPATÍA

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium

La Jolla Pharmaceutical Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

730

Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy

404

EUCTR2007-002566-35-ES
(EUCTR)

14/02/2008

20/12/2007

Estudio en fase IIb aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis y pauta posológica, para evaluar la seguridad y eficacia de epratuzumab en pacientes con lupus eritematoso sistémico con serología positiva y enfermedad activa.A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients with Active Disease. - SL0007

Lupus eritematoso sistémicosystemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2

UCB Inc

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

210

Phase 2b

Hungary;United Kingdom;Belgium;Spain;Lithuania

405

EUCTR2007-002566-35-LT
(EUCTR)

11/02/2008

04/12/2007

systemic lupus erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: epratuzumab
Product Code: CDP3194
INN or Proposed INN: epratuzumab
Other descriptive name: hLL2

UCB Inc

NULL

Not Recruiting

Female: yes
Male: yes

210

Phase 2b

Hungary;United Kingdom;Belgium;Spain;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

406

NCT00626197
(ClinicalTrials.gov)

February 2008

20/2/2008

A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus

Lupus Nephritis;Systemic Lupus Erythematosus

Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo

Genentech, Inc.

Roche Pharma AG

Completed

16 Years

N/A

All

381

Phase 3

United States

407

EUCTR2006-005357-29-DE
(EUCTR)

31/01/2008

01/10/2007

Lupus Nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Portugal;Hungary;United Kingdom;Germany;Netherlands;Bulgaria;France;Spain;Sweden

408

EUCTR2006-005357-29-SE
(EUCTR)

30/01/2008

21/12/2007

Lupus Nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden

409

EUCTR2006-000674-73-DE
(EUCTR)

23/01/2008

16/10/2007

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-ARM,PARALLEL-GROUP, MULTICENTER, MULTINATIONAL SAFETY ANDEFFICACY TRIAL OF 300 MG AND 900 MG OF ABETIMUS SODIUM INSYSTEMIC LUPUS ERYTHEMATOSUS (SLE) PATIENTS WITH A HISTORY OFRENAL DISEASE

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium

La Jolla Pharmaceutical Company

NULL

Not Recruiting

Female: yes
Male: yes

850

Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy

410

EUCTR2006-000674-73-PT
(EUCTR)

11/01/2008

17/09/2007

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium

La Jolla Pharmaceutical Company

NULL

Not Recruiting

Female: yes
Male: yes

730

Portugal;Czech Republic;Hungary;Spain;Bulgaria;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

411

EUCTR2006-000674-73-CZ
(EUCTR)

07/01/2008

25/10/2007

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium

La Jolla Pharmaceutical Company

NULL

Not Recruiting

Female: yes
Male: yes

730

Portugal;Hungary;Germany;Czech Republic;Bulgaria;Spain;Italy

412

NCT00624338
(ClinicalTrials.gov)

January 2008

15/2/2008

Atacicept Phase 2/3 in Generalized Systemic Lupus Erythematosus (APRIL-SLE)

A Randomised, Double-blind, Placebo Controlled, Multicentre Prospective Dose-finding Phase II/III Study With Atacicept Given Subcutaneously to Subjects Having Recently Experienced a Flare of Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus, Systemic

Drug: Atacicept 75 mg;Drug: Atacicept 150 mg;Other: Placebo Comparator

EMD Serono

Merck KGaA

Completed

16 Years

N/A

All

461

Phase 2;Phase 3

United States;Argentina;Australia;Austria;Bulgaria;Croatia;Czech Republic;France;Germany;Greece;India;Israel;Korea, Republic of;Latvia;Lebanon;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;Ukraine;United Kingdom

413

NCT00624351
(ClinicalTrials.gov)

January 2008

15/2/2008

Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

Systemic Lupus Erythematosus

Biological: Epratuzumab;Other: Placebo

UCB Pharma

NULL

Completed

18 Years

N/A

Both

227

Phase 2

United States;Belgium;Brazil;Hong Kong;Hungary;India;Lithuania;Poland;Spain;Ukraine;United Kingdom

414

NCT00539838
(ClinicalTrials.gov)

December 19, 2007

3/10/2007

A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN)

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo

Genentech, Inc.

Roche Pharma AG

Terminated

16 Years

N/A

All

Phase 3

United States

415

EUCTR2006-005177-21-AT
(EUCTR)

06/12/2007

26/02/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;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

416

NCT02291588
(ClinicalTrials.gov)

December 2007

3/11/2014

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 811 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: AMG 811;Drug: Placebo

Amgen

NULL

Completed

18 Years

65 Years

Both

Phase 1

NULL

417

EUCTR2006-005357-29-HU
(EUCTR)

21/11/2007

18/10/2007

Lupus Nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

369

Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden

418

EUCTR2006-005355-16-HU
(EUCTR)

21/11/2007

18/10/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

423

Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden

419

EUCTR2005-004575-37-BE
(EUCTR)

21/11/2007

15/06/2007

A Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).Revised Protocol 05, incorporating Protocol Amendment 05 (V2.0, dated 08-Feb-2008), Administrative Letter 01 (dated 13-Jun-2007), Amendment 07 (V1.0, dated 17-Apr-2008), Amendment 11 (V1.0, dated 11-Dec-2008), Amendment 13 (V1.0, dated 30-Apr-2010), Amendment 14 (V1.0, dated 12-Oc t-2010), Administrative Letter 04 (V1.0, dated 15-Oct-2009), Administrative Letter 05 (V1.0, dated 02-Dec-2009), and Administrative Letter 06 (V1.0, dated 12-May-2010) + Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (V2.0, Date 19-Jan-07). And Protocol Amendment 02 - Site specific (v1.0, date 09-Mar-2007).

IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

460

Phase 2;Phase 3

France;Belgium;United Kingdom

420

EUCTR2006-005355-16-FR
(EUCTR)

15/11/2007

28/08/2007

A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

423

Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;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

421

EUCTR2007-004635-29-DK
(EUCTR)

09/11/2007

02/10/2007

Randomised, placebo controlled, international multi-centre, double blind, dose confirmation study testing the safety and efficacy of ASF-1096 cream 0.25%, 0.5% and 1% and placebo applied twice daily in the treatment of cutaneous lupus erythematosus lesions - ASF-1096-301

Patients with Discoid Lupus Erythematosus (DLE) or Subacute Cutaneous Lupus Erythematosus (SCLE) symptoms of the skin can be included in this study. Those patients who have a diagnosis of Systemic Lupus Erythematosus (SLE) with DLE or SCLE lesions of the skin can also be included in the study.

Product Name: ASF-1096 Cream 0.25%
INN or Proposed INN: R-salbutamol sulphate
Product Name: ASF-1096 Cream 0.5%
INN or Proposed INN: R-salbutamol sulphate
Product Name: ASF-1096 Cream 1.0%
INN or Proposed INN: R-salbutamol sulphate

Astion Pharma A/S

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Denmark;Spain;Sweden

422

EUCTR2006-005357-29-FR
(EUCTR)

09/11/2007

24/08/2007

Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis
MedDRA version: 9.1;Level: LLT;Classification code 10025140;Term: Lupus nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Phase 3

Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden

423

EUCTR2007-004635-29-SE
(EUCTR)

07/11/2007

12/09/2007

Astion Pharma A/S

NULL

Not Recruiting

Female: yes
Male: yes

140

Denmark;Spain;Sweden

424

EUCTR2006-005177-21-IT
(EUCTR)

20/09/2007

13/07/2007

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B?), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) - HGS1006-C1056

Systemic Lupus Erythematosus
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Belimumab
Product Code: HGS1006

HUMAN GENOME SCIENCES INC

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

425

NCT00739050
(ClinicalTrials.gov)

September 19, 2007

19/8/2008

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)

Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: simvastatin;Drug: Comparator: Placebo

Merck Sharp & Dohme Corp.

NULL

Terminated

18 Years

N/A

Female

Phase 4

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

426

EUCTR2006-005177-21-FR
(EUCTR)

11/09/2007

23/07/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

427

EUCTR2006-005177-21-NL
(EUCTR)

03/08/2007

04/06/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

428

EUCTR2006-005177-21-SE
(EUCTR)

08/06/2007

07/05/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

429

NCT00482989
(ClinicalTrials.gov)

June 2007

4/6/2007

A Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI 545 in Patients With Systemic Lupus Erythematosus

A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple Intravenous Doses of MEDI-545, a Fully Human Anti-Interferon-Alpha Monoclonal Antibody, in Patients With Systemic Lupus Erythematosus

Lupus

Biological: MEDI 545;Other: Placebo

MedImmune LLC

NULL

Completed

18 Years

N/A

Both

183

Phase 1

United States;Argentina;Brazil;Chile;Canada

430

NCT00430677
(ClinicalTrials.gov)

June 2007

1/2/2007

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Systemic Lupus Erythematosus

Drug: Corticosteroids (prednisone or prednisolone);Drug: Abatacept;Drug: Mycophenolate mofetil (MMF)

Bristol-Myers Squibb

NULL

Terminated

18 Years

N/A

All

423

Phase 2;Phase 3

United States;Argentina;Australia;Belgium;Brazil;Canada;China;France;Hong Kong;India;Korea, Republic of;Mexico;Poland;Russian Federation;South Africa;Taiwan;Turkey;United Kingdom;Japan;Philippines;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

431

EUCTR2006-005177-21-GB
(EUCTR)

29/05/2007

02/01/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

432

EUCTR2006-005177-21-SK
(EUCTR)

17/05/2007

20/03/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

France;Czech Republic;Slovakia;Spain;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden

433

EUCTR2006-005177-21-ES
(EUCTR)

09/05/2007

09/03/2007

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE)Un estudio de fase III, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 76 semanas para evaluar la eficacia y la seguridad de belimumab (HGS1006, LymphoStat-BTM), un anticuerpo monoclonal totalmente humano anti-BLyS, en pacientes con lupus eritematoso sistémico (LES) - BLISS-76

Systemic Lupus Erythematosus (SLE)Lupus Eritematoso Sistémico
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

434

EUCTR2006-005177-21-BE
(EUCTR)

07/05/2007

29/01/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

435

EUCTR2006-005177-21-DE
(EUCTR)

03/05/2007

20/02/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Spain;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

436

NCT00424476
(ClinicalTrials.gov)

May 2007

17/1/2007

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Wk Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg

Human Genome Sciences Inc.

GlaxoSmithKline

Completed

18 Years

N/A

All

865

Phase 3

Argentina;Australia;Brazil;Chile;Colombia;Hong Kong;India;Korea, Republic of;Peru;Philippines;Romania;Russian Federation;Taiwan;Bulgaria;China

437

EUCTR2005-004575-37-FR
(EUCTR)

27/04/2007

26/03/2007

A Sequential Adaptive Phase II/III Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo on a Background of Mycophenolate Mofetil and Glucocorticosteroids in Subjects with Active Proliferative Glomerulonephritis Due to Systemic Lupus Erythematosus (SLE).And Pharmacogenetics Blood Sample Amendment Number 1 - Site Specific (Version 2.0, Date 19-Jan-07).

IMMUNOSUPPRESSION FOR DISEASE, NOS
MedDRA version: 9.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig
Trade Name: CellCept
Product Name: mycophenolate mofetil
INN or Proposed INN: mycophenolate mofetil
Other descriptive name: CellCept

Bristol-Myers Squibb International Corporation

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

460

Phase 2;Phase 3

United Kingdom;Belgium;France

438

EUCTR2006-005177-21-CZ
(EUCTR)

23/04/2007

28/02/2007

Systemic Lupus Erythematosus (SLE)
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: belimumab
Product Code: HGS1006
INN or Proposed INN: belimumab
Other descriptive name: LymphoStat-B TM

Human Genome Sciences, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

810

Phase 3

Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden

439

NCT00668330
(ClinicalTrials.gov)

April 2007

25/4/2008

Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus

Steroid Induced Osteoporosis in Patients With Systemic Lupus Erythematosus-Prevalence,Risk Factors and Treatment

Systemic Lupus Erythematosus

Drug: Ibandronate +alfacalcidol+calcium;Drug: placebo ibandronate +alfacalcidol+calcium

Chinese University of Hong Kong

NULL

Completed

18 Years

80 Years

Female

Phase 4

China

440

EUCTR2006-001062-17-SE
(EUCTR)

07/03/2007

12/01/2007

Efficacy and safety of ASF-1096 Cream 0.5% in the treatment of patients with newly developed discoid lupus erythematosus (DLE) lesions. A multi centre clinical phase 2, placebo controlled and double blind proof of concept study. - Lupus study

Male or female patients with a clinical diagnosis of either Discoid Lupus Erythematosus or Systemic Lupus Erythematosus and at least one newly developed, sharply demarcated DLE lesion.
MedDRA version: 8.1;Level: LLT;Classification code 10025138;Term:

Product Name: ASF-1096 Cream 0.5%

Astion Danmark A/S

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

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

441

JPRN-UMIN000000639

2007/03/01

16/03/2007

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus

Systemic lupus erythematosus

IDEC-C2B8 plus oral prednisolone(tapering)
1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Placebo plus oral prednisolone(tapering)
1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).

Zenyaku Kogyo Co., Ltd.

NULL

Complete: follow-up complete

16years-old

75years-old

Male and Female

150

Phase 2;Phase 3

Japan

442

NCT01702740
(ClinicalTrials.gov)

March 2007

6/7/2012

A Study of the Safety and Pharmacokinetics of CNTO 136 in Patients With Cutaneous Lupus Erythematosus and Systemic Lupus Erythematosus

A Phase 1, Double-blind, Placebo-controlled, Multiple Intravenous, Ascending-Dose Study of CNTO 136 to Evaluate Safety and Pharmacokinetics in Subjects With Cutaneous Lupus Erythematosus and to Evaluate Safety and Pharmacokinetics in a Cohort of Subjects With Systemic Lupus Erythematosus

Lupus Erythematosus, Cutaneous;Lupus Erythematosus, Systemic

Drug: 1 mg/kg CNTO 136;Drug: 4 mg/kg CNTO 136;Drug: 10 mg/kg CNTO 136;Drug: Placebo

Centocor Research & Development, Inc.

NULL

Completed

18 Years

70 Years

Both

Phase 1

NULL

443

NCT01322308
(ClinicalTrials.gov)

March 2007

23/3/2011

Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus

Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus, a Randomized, Double-blind, Placebo-controlled Clinical Trial

Systemic Lupus Erythematosus

Drug: pioglitazone;Drug: placebo

National Heart Institute, Mexico

National Council of Science and Technology, Mexico;Universidad Nacional Autonoma de Mexico

Completed

18 Years

55 Years

Female

Phase 4

NULL

444

NCT00541749
(ClinicalTrials.gov)

February 2007

7/10/2007

A Study of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: rhuMAb IFNalpha

Genentech, Inc.

NULL

Completed

18 Years

65 Years

Both

Phase 1

United States

445

NCT00410384
(ClinicalTrials.gov)

December 2006

8/12/2006

A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 76-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 10 mg/kg

Human Genome Sciences Inc.

GlaxoSmithKline

Completed

18 Years

N/A

All

819

Phase 3

United States;Austria;Belgium;Canada;Costa Rica;Czech Republic;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Romania;Slovakia;Spain;Sweden;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

NCT00594932
(ClinicalTrials.gov)

November 2006

4/1/2008

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis

Systemic Lupus Erythematosus;Arthritis

Drug: mycophenolate mofetil;Other: placebo

Oklahoma Medical Research Foundation

NYU Langone Health

Completed

14 Years

70 Years

All

Phase 1;Phase 2

United States

447

NCT02391259
(ClinicalTrials.gov)

November 2006

6/1/2015

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Randomized, Multicenter, Double-Blind, Placebo-Controlled, Rising Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: AMG 557;Drug: Placebo

Amgen

NULL

Completed

18 Years

70 Years

Both

Phase 1

United States;United Kingdom

448

EUCTR2006-000674-73-SK
(EUCTR)

09/10/2006

09/08/2006

A Randomized, Double-Blind, Placebo-Controlled, Four-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 100 mg, 300 mg, and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients with a History of Renal Disease

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium

La Jolla Pharmaceutical Company

NULL

Not Recruiting

Female: yes
Male: yes

588

Phase 3

Portugal;Czech Republic;Hungary;Slovakia;Spain;Bulgaria;Germany;Italy

449

EUCTR2005-004067-30-DE
(EUCTR)

05/10/2006

11/05/2006

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNFafa Chimeric Monoclonal Antibody (Infliximab, Remicade®) and Azathioprine in Patients Suffering from Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine

Department of Rheumatology, Internal Medicine III, Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Netherlands;Austria

450

NCT00368264
(ClinicalTrials.gov)

September 2006

23/8/2006

TNF Blockade With Remicade in Active Lupus Nephritis WHO Class V (TRIAL )

A Double Blind, Randomized, Placebo Controlled, Multi-Center Trial of Anti-TNF-alpha Chimeric Monoclonal Antibody (Infliximab) and Azathioprine in Patients Suffering From Systemic Lupus Erythematosus (SLE) With WHO Class V Glomerulonephritis

Lupus Erythematosus, Systemic;Lupus Nephritis

Drug: infliximab;Drug: placebo

Medical University of Vienna

Hospital Hietzing;Medical University of Graz;Charite University, Berlin, Germany;University of Erlangen-Nürnberg;Heinrich-Heine University, Duesseldorf;University Medical Centre Groningen;Leiden University Medical Center;Radboud University

Terminated

18 Years

N/A

Both

Phase 2;Phase 3

Austria;Germany;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

451

EUCTR2006-000674-73-HU
(EUCTR)

11/08/2006

15/06/2006

Systemic lupus erythematosus patients with a history of renal disease
MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Abetimus sodium
Product Code: LJP 394
INN or Proposed INN: Abetimus Sodium

La Jolla Pharmaceutical Company

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

730

Portugal;Hungary;Czech Republic;Germany;Bulgaria;Spain;Italy

452

EUCTR2005-004067-30-NL
(EUCTR)

08/08/2006

20/04/2006

Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine

Department of Rheumatology, Internal Medicine III, Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Netherlands;Austria

453

NCT00383513
(ClinicalTrials.gov)

June 2006

29/9/2006

Study of Epratuzumab in Systemic Lupus Erythematosus

An Open-Label Re-treatment Trial for Patients Previously Randomized Into the SL0003 and SL0004, Randomized, Double-blind, Placebo-controlled, Multi-center Studies of Epratuzumab in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: Epratuzumab

UCB Pharma

NULL

Completed

18 Years

N/A

Both

Phase 2

United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom

454

NCT00371501
(ClinicalTrials.gov)

June 2006

1/9/2006

Aspirin and Statins for Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus

Low Dose Aspirin and Statins for Primary Prevention of Atherosclerosis and Arterial Thromboembolism in Systemic Lupus Erythematosus: A Randomized Double-blind Placebo-controlled Trial

Atherosclerosis;Thromboembolism;Systemic Lupus Erythematosus

Drug: Rosuvastatin;Drug: placebo;Drug: aspirin

Tuen Mun Hospital

AstraZeneca

Completed

18 Years

N/A

Both

Phase 4

Hong Kong

455

EUCTR2004-004051-19-IT
(EUCTR)

26/05/2006

30/08/2006

Phase IIb, multi 8722;center, randomized, double 8722;blind, placebo 8722;controlled study to evaluate the efficacy and safety of abatacept vs placebo on a background of oral glucocorticosteroids in the tratment of subjects with systemic lupus erythematosus and the prevention of subsequent lupus flares - ND

Systemic Lupus Erythematosus
MedDRA version: 6.1;Level: HLT;Classification code 10025136

Product Name: abatacept

Bristol Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2b

United Kingdom;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

456

EUCTR2005-004067-30-AT
(EUCTR)

08/05/2006

31/03/2006

Systemic Lupus Erythematosus (SLE) with WHO Class V Glomerulonephritis

Trade Name: Remicade
Product Name: Remicade
INN or Proposed INN: Infliximab
Trade Name: Azathioprine
Other descriptive name: Azathioprine

Department of Rheumatology, Internal Medicine III, Medical University of Vienna

NULL

Not Recruiting

Female: yes
Male: yes

Germany;Netherlands;Austria

457

EUCTR2005-000705-59-DE
(EUCTR)

11/04/2006

07/06/2005

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems - Phase III Study of Epratuzumab in Severe Acute SLE Flares

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

UCB Pharma, Inc

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Hungary;United Kingdom;Germany;Spain;Italy

458

NCT00299819
(ClinicalTrials.gov)

March 2006

6/3/2006

Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)

A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)

Lupus

Biological: MEDI-545;Biological: MEDI 545

MedImmune LLC

NULL

Completed

18 Years

80 Years

Both

Phase 1

United States;Canada

459

NCT00181298
(ClinicalTrials.gov)

March 2006

13/9/2005

Memantine in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: Memantine;Drug: Placebo

Johns Hopkins University

Forest Laboratories

Completed

18 Years

N/A

Both

N/A

United States

460

NCT01101802
(ClinicalTrials.gov)

March 2006

9/4/2010

Mycophenolate Mofetil in Systemic Lupus Erythematosus (MISSILE)

A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.

Systemic Lupus Erythematosus;Atherosclerosis

Drug: Mycophenolate mofetil;Drug: sugar pill

Guy's and St Thomas' NHS Foundation Trust

Institute of Child Health, University College London, London, UK.

Completed

18 Years

60 Years

Female

Phase 4

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

461

EUCTR2005-000705-59-HU
(EUCTR)

09/01/2006

12/10/2005

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

Immunomedics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

510

Phase 3

Hungary;Germany;United Kingdom;Spain;Italy

462

EUCTR2005-000706-31-DE
(EUCTR)

05/01/2006

28/06/2005

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

UCB Pharma Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

United Kingdom;Germany;Spain;Italy

463

EUCTR2005-000705-59-SK
(EUCTR)

14/10/2005

29/07/2005

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial of Epratuzumab in Patients with Acute Severe SLE Flares Excluding the Renal or Neurological Systems. - Phase III Study of Epratuzumab in Severe Acute SLE Flares

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

Immunomedics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Hungary;Slovakia;Spain;Germany;Italy;United Kingdom

464

EUCTR2005-001391-12-GB
(EUCTR)

12/10/2005

15/06/2005

A multi-national, multi-centre, randomized, double-blind, placebo-controlled, multiple-dose, parallel-group study to assess the efficacy, tolerability and safety of three doses of edratide (TV-4710) for injection administered subcutaneously to systemic lupus erythematosus (SLE) patients - PRELUDE

Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945

TEVA Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 2

Hungary;Spain;Germany;Italy;United Kingdom

465

EUCTR2005-001391-12-DE
(EUCTR)

23/09/2005

15/07/2005

Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945

Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide

TEVA Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

260

Hungary;United Kingdom;Germany;Spain;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

466

EUCTR2005-001688-74-GB
(EUCTR)

22/09/2005

16/08/2005

A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)

Atherosclerosis in patients with Systemic Lupus Erythematosis

Guy's & St Thomas' NHS Foundation Trust

NULL

Not Recruiting

Female: yes
Male: no

100

Phase 4

United Kingdom

467

EUCTR2005-000706-31-IT
(EUCTR)

15/09/2005

30/09/2005

A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients with Active Systemic LupusErythematosus

improvement of signs and symptoms of Active Systemic Lupus Erythematosus
MedDRA version: 8.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus

Product Name: Epatuzumab
Product Code: hLL2,IMMU-103

IMMUNOMEDICS

NULL

Not Recruiting

Female: yes
Male: yes

Phase 3

Germany;United Kingdom;Spain;Italy

468

EUCTR2005-001391-12-ES
(EUCTR)

01/09/2005

07/07/2005

Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945

Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide
Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide

TEVA Pharmaceutical Industries, Ltd.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

260

Hungary;Germany;United Kingdom;Spain;Italy

469

NCT00119678
(ClinicalTrials.gov)

September 2005

30/6/2005

Abatacept in the Treatment and Prevention of Active Systemic Lupus Erythematosus (SLE) Flares in Combination With Prednisone

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept vs Placebo on a Background of Oral Glucocorticosteroids in the Treatment of Subjects With Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares

Systemic Lupus Erythematosus

Drug: Abatacept;Drug: Placebo;Drug: Prednisone

Bristol-Myers Squibb

NULL

Completed

18 Years

N/A

All

183

Phase 2

United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Italy;Korea, Republic of;Mexico;Puerto Rico;South Africa;Taiwan;United Kingdom;Sweden

470

EUCTR2004-004051-19-AT
(EUCTR)

30/08/2005

26/07/2005

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol 1.0 (incorporating Amendment 2) dated 03-June-2005 + Amendment 1 dated 08-Feb-2005

SYSTEMIC LUPUS ERYTHEMATOSUS, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2B

Austria;Germany;Italy;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

471

EUCTR2004-004051-19-BE
(EUCTR)

29/08/2005

29/06/2005

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy with Glucocorticosteroids vs. Placebo plus Glucocorticosteroids in the Treatment of Active Systemic Lupus Erythematosus and the Prevention of Subsequent Lupus Flares. Revised Protocol 03: Incorporates Amendments 2, 3 & 5 (v1.0, Date 22-Jun-2007). Protocol Amendment 1 - Site Specific. And Protocol Amendment 04: Long Term Extension (v 3.0, dated 30-Aug-2006).

SYSTEMIC LUPUS ERYTHEMATOSUS, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2B

Belgium;Austria;Germany;Italy;United Kingdom;Sweden

472

EUCTR2005-001391-12-IT
(EUCTR)

28/07/2005

23/03/2006

A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Three Doses of Edratide TV-4710 for Injection Administered Subcutaneously to Systemic Lupus Erythematosus SLE patients

Treatment of active SLE patients who are concurrently undergoing a regimented program of decreased steroid use.
MedDRA version: 6.1;Level: PT;Classification code 10042945

Product Name: Edratide Acetate
Product Code: TV-4710
Product Name: Edratide Acetate
Product Code: TV-4710
Product Name: Edratide Acetate
Product Code: TV-4710

TEVA

NULL

Not Recruiting

Female: yes
Male: yes

260

Hungary;Germany;United Kingdom;Spain;Italy

473

EUCTR2005-001391-12-HU
(EUCTR)

27/07/2005

15/06/2005

Systemic lupus erythematosus (SLE)
MedDRA version: 7.1;Level: PT;Classification code 10042945

Product Name: edratide
Product Code: TV-4710
INN or Proposed INN: edratide

TEVA Pharmaceutical Industries, Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

260

Hungary;Germany;United Kingdom;Spain;Italy

474

EUCTR2005-000706-31-ES
(EUCTR)

25/07/2005

23/05/2006

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
INN or Proposed INN: Epratuzumab
Other descriptive name: hLL2 (trivial name or chemical description)

Immunomedics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

300

Phase 3

Germany;United Kingdom;Spain;Italy

475

NCT00203151
(ClinicalTrials.gov)

July 2005

13/9/2005

A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus

A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: edratide

Teva Pharmaceutical Industries

NULL

Terminated

18 Years

65 Years

Both

340

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

476

EUCTR2005-000706-31-BE
(EUCTR)

29/06/2005

26/07/2005

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

UCB Pharma Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

Spain;Belgium;Germany;Italy;United Kingdom

477

EUCTR2005-000705-59-GB
(EUCTR)

07/06/2005

19/04/2005

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

Immunomedics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 3

Hungary;Germany;United Kingdom;Spain;Italy

478

EUCTR2004-004051-19-SE
(EUCTR)

01/06/2005

29/03/2005

A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study toEvaluate the Efficacy and Safety of Abatacept vs. Placebo on a Background of OralGlucocorticosteroids in the Treatment of Subjects with Systemic Lupus Erythematosusand the Prevention of Subsequent Lupus Flares.Revised Protocol Number 02: Incorporates Amendments 2 & 3 - Protocol Amendment 1 - Site Specific.

SYSTEMIC LUPUS ERYTHEMATOSUS, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2B

United Kingdom;Germany;Italy;Sweden

479

NCT00111306
(ClinicalTrials.gov)

June 2005

19/5/2005

Study of Epratuzumab in Systemic Lupus Erythematosus

A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

Systemic Lupus Erythematosus

Drug: epratuzumab

UCB Pharma

NULL

Terminated

18 Years

N/A

Both

510

Phase 3

United States;Belgium;Hungary;Netherlands;Spain;United Kingdom

480

EUCTR2004-004051-19-DE
(EUCTR)

13/05/2005

22/03/2005

SYSTEMIC LUPUS ERYTHEMATOSUS, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2B

United Kingdom;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

481

EUCTR2005-000706-31-GB
(EUCTR)

13/05/2005

19/04/2005

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Studyof Epratuzumab in Patients with Active Systemic Lupus Erythematosus - Phase III Study of Epratuzumab in Active SLE

Systemic Lupus Erythematosus
Classification code 10042945

Product Name: Epratuzumab
Product Code: IMMU-103
Other descriptive name: hLL2 (trivial name or chemical description)

Immunomedics, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

300

Phase 3

Germany;United Kingdom;Spain;Italy

482

NCT00137969
(ClinicalTrials.gov)

May 10, 2005

26/8/2005

A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic

Drug: Rituximab;Drug: Placebo;Drug: Prednisone;Drug: Acetaminophen;Drug: Diphenhydramine

Genentech, Inc.

NULL

Completed

16 Years

75 Years

All

262

Phase 2;Phase 3

United States;Canada

483

NCT00383214
(ClinicalTrials.gov)

May 2005

29/9/2006

Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.

Systemic Lupus Erythematosus

Drug: Epratuzumab;Other: Placebo

UCB Pharma

NULL

Terminated

18 Years

N/A

Both

Phase 3

United States;Belgium;Brazil;Canada;Czech Republic;France;Germany;Italy;Netherlands;Spain;United Kingdom

484

NCT02411136
(ClinicalTrials.gov)

May 2005

3/4/2015

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 623 in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: AMG 623;Drug: Placebo

Amgen

NULL

Completed

18 Years

65 Years

Both

Phase 1

NULL

485

EUCTR2004-004051-19-GB
(EUCTR)

18/04/2005

24/03/2005

SYSTEMIC LUPUS ERYTHEMATOSUS, NOS

Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: Abatacept
Other descriptive name: CTLA4Ig

Bristol-Myers Squibb International Corporation

NULL

Not Recruiting

Female: yes
Male: yes

250

Phase 2B

Germany;United Kingdom;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

486

NCT02443506
(ClinicalTrials.gov)

October 2004

11/5/2015

A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus

A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: AMG 623;Drug: Placebo

Amgen

NULL

Completed

18 Years

55 Years

Both

Phase 1

NULL

487

NCT00089804
(ClinicalTrials.gov)

October 2004

13/8/2004

Study of LJP 394 in Lupus Patients With History of Renal Disease

A Randomized, Double-Blind, Placebo-Controlled, Three-Arm, Parallel-Group, Multicenter, Multinational Safety and Efficacy Trial of 300 mg and 900 mg of Abetimus Sodium in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

Lupus Erythematosus, Systemic;Lupus Nephritis

Drug: abetimus sodium (LJP 394) and/or placebo solution;Drug: abetimus sodium (LJP 394);Drug: Phosphate -buffered saline

La Jolla Pharmaceutical Company

NULL

Terminated

12 Years

70 Years

Both

943

Phase 3

United States;Argentina;Australia;Belarus;Brazil;Bulgaria;Czech Republic;Georgia;Germany;Hong Kong;Hungary;India;Indonesia;Italy;Korea, Republic of;Lebanon;Malaysia;Mexico;Philippines;Poland;Portugal;Puerto Rico;Romania;Serbia;Slovakia;Spain;Sri Lanka;Taiwan;Thailand;Ukraine;Former Serbia and Montenegro

488

NCT00071487
(ClinicalTrials.gov)

October 2003

24/10/2003

Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of LymphoStat-B™ Antibody (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus (SLE)

Lupus Erythematosus, Systemic

Drug: Placebo;Drug: Belimumab 1 mg/kg;Drug: Belimumab 4 mg/kg;Drug: Belimumab 10 mg/kg

Human Genome Sciences Inc.

NULL

Completed

18 Years

65 Years

All

449

Phase 2

United States;Canada

489

NCT00637819
(ClinicalTrials.gov)

January 2003

11/3/2008

Leflunomide in Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)

Systemic Lupus Eythematosus (SLE)

Drug: Leflunomide

Sanofi

NULL

Completed

18 Years

N/A

Both

Phase 2

Hong Kong

490

NCT00053560
(ClinicalTrials.gov)

December 2002

30/1/2003

To Assess Prevention of Bone Loss in Women With Lupus Receiving Treatment With Glucocorticoids

A Randomized, Double-Blind, Multi-Center, Placebo- Controlled Study to Assess Prevention of Bone Loss by Treatment With GL701 (Prestara) in Women With Systemic Lupus Erythematosus Receiving Treatment With Glucocorticoids

Lupus

Drug: Prasterone (GL701)

Genelabs Technologies

NULL

Active, not recruiting

18 Years

N/A

Female

155

Phase 3

United States;Mexico

No.

TrialID

Date_
enrollment

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

NCT00412841
(ClinicalTrials.gov)

November 2002

18/12/2006

Atorvastatin to Prevent Avascular Necrosis of Bone in Steroid Treated Exacerbated Systemic Lupus Erythematosus

AVN Prevention With Lipitor in Lupus Erythematosus APLLE Trial

Avascular Necrosis

Drug: Atorvastatin;Procedure: MRI, Venipuncture;Drug: Placebo

NYU Langone Health

NULL

Terminated

18 Years

75 Years

Female

Phase 2

United States

492

NCT00657007
(ClinicalTrials.gov)

February 2002

8/4/2008

Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)

A Phase 1, Multi-Center, Double-Blind, Single and Double Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Biological: belimumab;Biological: Placebo

Human Genome Sciences Inc.

NULL

Completed

18 Years

N/A

Both

Phase 1

United States

493

NCT00035308
(ClinicalTrials.gov)

November 2001

2/5/2002

Safety and Efficacy Study of LJP 394 (Abetimus Sodium) to Treat Lupus Kidney Disease

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

Immunologic Diseases;Autoimmune Diseases;Systemic Lupus Erythematosus;Lupus Nephritis;Lupus Glomerulonephritis

Drug: Abetimus sodium (LJP 394)

La Jolla Pharmaceutical Company

NULL

Completed

12 Years

70 Years

Both

330

Phase 3

United States;Austria;Canada;France;Germany;Italy;Mexico;Spain;Sweden;United Kingdom

494

NCT00000421
(ClinicalTrials.gov)

September 1997

3/11/1999

Serologically Active, Clinically Stable Systemic Lupus Erythematosus

Serologically Active, Clinically Stable Systemic Lupus Erythematosus (SLE)

Systemic Lupus Erythematosus

Drug: Prednisone;Drug: Placebo

New York University School of Medicine

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Completed

13 Years

65 Years

Female

154

Phase 2

United States

495

NCT00004662
(ClinicalTrials.gov)

March 1996

24/2/2000

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: dehydroepiandrosterone

National Center for Research Resources (NCRR)

Northwestern University

Completed

18 Years

N/A

Female

300

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

496

NCT00470522
(ClinicalTrials.gov)

June 1995

2/5/2007

Study of Methotrexate in Lupus Erythematosus

A Canadian Multicenter, Randomized, Double-Blind Placebo-Controlled Study of Methotrexate and Folic Acid in Systemic Lupus Erythematosus: A Phase III Trial.

Systemic Lupus Erythematosus

Drug: Methotrexate and folic acid

University Health Network, Toronto

McGill University Health Center

Completed

18 Years

N/A

Both

Phase 3

Canada

497

NCT00004795
(ClinicalTrials.gov)

August 1994

24/2/2000

Phase II/III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Mild to Moderate Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Drug: dehydroepiandrosterone

National Center for Research Resources (NCRR)

Northwestern University

Completed

18 Years

N/A

Female

190

Phase 2;Phase 3

NULL

498

JPRN-JapicCTI-153064

11/11/2015

TULIP

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

Active Systemic Lupus Erythematosus

Intervention name : anifrolumab
INN of the intervention : anifrolumab
Dosage And administration of the intervention : Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses

AstraZeneca

NULL

complete

BOTH

Phase 3

NULL

499

EUCTR2011-000368-88-PL
(EUCTR)

04/06/2012

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Mexico;Canada;Argentina;Brazil;Spain;Poland;Peru;Russian Federation;Netherlands;Italy;United Kingdom

500

EUCTR2019-003406-27-PT
(EUCTR)

29/06/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Female: yes
Male: yes

450

Phase 3

United States;Serbia;Portugal;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Argentina;Colombia;Switzerland;Italy;France;Australia;Peru;Netherlands;Korea, Republic of;Czechia;Lithuania;Austria;United Kingdom;Hungary;Mexico;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden;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

501

EUCTR2006-005357-29-PL
(EUCTR)

10/01/2008

Lupus Nephritis

Product Name: ocrelizumab
Product Code: RO 496-4913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMAb 2H7

F. Hoffmann-La Roche Ltd

NULL

Not Recruiting

Female: yes
Male: yes

369

Phase 3

Portugal;France;Hungary;Spain;Poland;Bulgaria;Netherlands;Germany;United Kingdom;Sweden

502

EUCTR2019-003406-27-PL
(EUCTR)

14/04/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Female: yes
Male: yes

450

Phase 3

503

EUCTR2019-003406-27-BE
(EUCTR)

28/02/2020

A Study to evaluate the efficacy and safety of dapirolizumab pegol in study participants with moderately to severely active systemic lupus erythematosus

Product Name: Dapirolizumab pegol
Product Code: CDP7657
INN or Proposed INN: Dapirolizumab pegol
Other descriptive name: CDP7657

UCB Biopharma SRL

NULL

Female: yes
Male: yes

450

Phase 3

Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Slovakia;Greece;Spain;Chile;Colombia;Switzerland;Italy;France;Peru;Australia;Netherlands;Korea, Republic of;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Sweden

504

JPRN-JapicCTI-184095

03/09/2018

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA)

Systemic Lupus Erythematosus

Intervention name : LY3009104
INN of the intervention : Baricitinib
Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally.

Eli Lilly Japan K.K.

NULL

recruiting

BOTH

Phase 3

NULL

505

EUCTR2011-000368-88-Outside-EU/EEA
(EUCTR)

17/02/2014

A clinical research study to evaluate the effect of belimumab for the treatment of Systemic Lupus Erythematosus (SLE) in paediatric patients 5 to 17 years of age

Systemic Lupus Erythematosus
MedDRA version: 16.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: BENLYSTA™ (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab

GlaxoSmithKline Research & Development Ltd

NULL

Female: yes
Male: yes

100

Argentina;Brazil;Netherlands;Mexico;Peru;Poland;Russian Federation;Germany;Canada;Italy;Spain;United Kingdom;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

506

EUCTR2018-004175-12-DE
(EUCTR)

02/08/2019

A Phase 2b multicenter dose ranging study to evaluate efficacy and safety of PF-06700841 in systemic lupus erythematosus

Pfizer Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

448

Phase 2

507

EUCTR2007-003698-13-DE
(EUCTR)

09/05/2008

Atacicept Phase II/III in Generalized Systemic Lupus Erythematosus (APRIL SLE)

Product Name: Atacicept
Product Code: TACI-Fc5
INN or Proposed INN: Atacicept
Other descriptive name: TACI-Fc5

Merck Serono S.A. Geneva. An affiliate of Merck KGaA, Darmstadt, Germany

NULL

Not Recruiting

Female: yes
Male: yes

510

Phase 2;Phase 3