At a glance
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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
In Brief
A Phase 3 clinical trial evaluating risankizumab IV, placebo for risankizumab, and 1 other intervention for Ulcerative Colitis (UC). Completed, enrolled 1,558 participants across 430 sites in 44 countries.
Detailed Summary
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Study Details
Timeline
Interventions
risankizumab intravenous (IV) infusion
placebo for risankizumab
risankizumab subcutaneous (SC) injection