Trial Details

Not Recruiting
Basic Information
Clinical ID c2772
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 System Diseases [C06]
Interventions Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB Current Sponsor code: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB Current Sponsor code: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
Participant Information
Sponsor AbbVie Deutschland GmbH & Co. KG
City -
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;Switzerland;Spain;New Zealand;Canada;Turkey;Belgium;Denmark;Mexico;South Africa;Italy;Israel;Germany
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE2|PHASE3
Time Information
Start Date 2025-04-24
Primary Completion Date 2024-05-25
Completion Date 2023-05-11