Trial Details
Not RecruitingBasic Information
| Clinical ID | c5085 |
|---|---|
| Identifier | EUCTR2016-004677-40-SE |
| Trial Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Ulcerative Colitis |
| Trial URL | Visit Original Page |
Study Information
| Study Results | Yes |
|---|---|
| Conditions | Ulcerative Colitis MedDRA version: 20.0.Level: PT.Classification code 10009900.Term: Colitis ulcerative.System Organ Class: 10017947 - Gastrointestinal disorders.;Therapeutic area: Diseases [C] - Digestive Syste |
| Interventions | Product Name: RisankizumabProduct Code: ABBV-066Pharmaceutical Form: Solution for infusionINN or Proposed INN: RISANKIZUMABCurrent Sponsor code: ABBV-066Concentration unit: mg/ml milligram(s)/millilitreConcentration type: equal |
Participant Information
| Sponsor | AbbVie Deutschland GmbH & Co. KG |
|---|---|
| City | NULL |
| Country/Region | Russia;United States;Czech Republic;Egypt;Malaysia;Portugal;Greece;Sweden;Austria;Latvia;Netherlands;China;Brazil;South Korea;Poland;Slovakia;Slovenia;Chile;France;Lithuania;Bulgaria;Serbia;Croatia;Colombia;Argentina;Romania;Japan;Ukraine;United Kingdom;S |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | NULL |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | PHASE2|PHASE3 |
Time Information
| Start Date | NULL |
|---|---|
| Primary Completion Date | NULL |
| Completion Date | NULL |