97. Ulcerative colitis Clinical trials / Disease details
Clinical trials : 2,630 / Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202
| No. | TrialID | Date_ enrollment | 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 | EUCTR2018-003349-41-DE (EUCTR) | 30/10/2019 | 19/12/2018 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany;Belarus;Serbia;United States;Ukraine | ||
| 2 | EUCTR2018-003349-41-IT (EUCTR) | 16/07/2019 | 17/06/2021 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis - CYC-202 | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: [FP-CYA-050] INN or Proposed INN: CICLOSPORIN Product Name: ST-0529 Product Code: [FP-CYA-053] INN or Proposed INN: CICLOSPORIN | Sublimity Therapeutics HoldCo Limited | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 3 | EUCTR2018-003349-41-FR (EUCTR) | 11/07/2019 | 27/05/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Belarus;Serbia;Spain;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 4 | EUCTR2018-003349-41-RO (EUCTR) | 01/07/2019 | 09/05/2022 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | United States;Belarus;Serbia;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 5 | EUCTR2018-003349-41-BG (EUCTR) | 29/05/2019 | 27/02/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Spain;Belarus;Serbia;United States;Ukraine;Ireland;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 6 | EUCTR2018-003349-41-GB (EUCTR) | 28/03/2019 | 21/12/2018 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 380 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Bulgaria;Germany | ||
| 7 | EUCTR2018-003349-41-PL (EUCTR) | 27/02/2019 | 15/01/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine Product Name: ST-0529 Product Code: FP-CYA-053 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 2 | Belarus;Serbia;United States;Ukraine;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Canada;Poland;Bulgaria;Germany | ||
| 8 | EUCTR2018-003349-41-HU (EUCTR) | 19/02/2019 | 08/01/2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 INN or Proposed INN: CICLOSPORIN Other descriptive name: cyclosporine | Sublimity Therapeutics (Hold Co) Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 380 | Phase 2 | Belarus;Serbia;United States;Spain;Ukraine;Ireland;Turkey;Israel;Russian Federation;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany | ||
| 9 | EUCTR2008-003169-19-GB (EUCTR) | 04/03/2010 | 17/09/2009 | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CyCol Product Code: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) | Sigmoid Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Ireland;United Kingdom | ||
| 10 | NCT01033305 (ClinicalTrials.gov) | March 2010 | 15/12/2009 | Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™) | A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: CyCol™;Drug: Placebo | Sigmoid Pharma | NULL | Completed | 18 Years | N/A | Both | 118 | Phase 2 | Ireland;United Kingdom |
| 11 | EUCTR2008-003169-19-IE (EUCTR) | 09/11/2009 | 05/06/2008 | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) Product Name: CyCol INN or Proposed INN: ciclosporin Other descriptive name: cyclosporine (USAN) | Sigmoid Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom;Ireland | |||
| 12 | EUCTR2008-001968-36-GB (EUCTR) | 27/08/2008 | 15/07/2008 | Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT | Comparison of infliximab and ciclosporin in steroid resistant ulcerative colitis: a Trial - CONSTRUCT | Acute severe steroid resistant ulcerative colitis MedDRA version: 14.1;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade Trade Name: Sandimmun Trade Name: Neoral Soft Gelatin Capsules | Swansea University | NULL | Not Recruiting | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 13 | EUCTR2006-005299-42-BE (EUCTR) | 20/05/2008 | 07/03/2008 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | |||
| 14 | EUCTR2006-005299-42-ES (EUCTR) | 19/05/2008 | 03/03/2008 | Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF | Estudio multicéntrico abierto randomizado que compara ciclosporina e infliximab para el tratamiento de la colitis ulcerosa grave corticorrefractaria.A randomized multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis - CYSIF | Brote grave de colitis ulcerosa (Severe flare of ulcerative colitis) | Trade Name: Sandimmum Product Name: ciclosporina Trade Name: Remicade Product Name: infliximab | GETECCU (Grupo Español para el estudio de la enfermedad de Crohn y la colitis ulcerosa) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | |||
| 15 | EUCTR2006-005299-42-FI (EUCTR) | 25/02/2008 | 27/12/2007 | A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY | A randomized, multicentre, open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitisSatunnaistettu, avoin, vertaileva monikeskustutkimus siklosporiinista ja infliximabista kortikosteroidille reagoimattoman vaikean haavaisen paksusuolitulehduksen hoidossa. - CYSIF STUDY | Tutkimuksessa verrataan kortikosteroidihoidolle reagoimattoman haavaisen paksusuolitulehduksen hoitoa käyttämällä suonensisäistä siklosporiinihoitoa 2 mg/kg/vrk 7 vrk:n ajan ja siklosporiini (Sandimmun Neoral) 4 mg/kg/vrk suun kautta tämän jälkeen 3 kk:n ajan verrattuna infliximabi (Remicade) 5 mg/kg iv viikoilla 0, 2 ja 6. MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Sandimmun 50 mg/ml, infuusiokonsentraatti INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Trade Name: Remicade 100 mg infuusiokuiva-aine, konsentraattiliuosta varten INN or Proposed INN: INFLIXIMAB | Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives (G.E.T.A.I.D.) | NULL | Not Recruiting | Female: yes Male: yes | 100 | France;Finland;Belgium;Spain | |||
| 16 | EUCTR2006-005299-42-FR (EUCTR) | 16/05/2007 | 06/03/2007 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally.- Severe acute flare of UC with a Lichtiger Index score > 10.- Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1;Level: LLT;Classification code 10045282;Term: UC | Trade Name: REMICADE INN or Proposed INN: INFLIXIMAB INN or Proposed INN: CICLOSPORIN Other descriptive name: SANDINUM INN or Proposed INN: CICLOSPORIN Other descriptive name: NEORAL Trade Name: CYCLOSPORIN Trade Name: CYCLOSPORIN | GETAID | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain |