A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis

NCT03398148 PHASE2, PHASE3 COMPLETED Results posted

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.

Details

Lead sponsor	AbbVie
Phase	PHASE2, PHASE3
Status	COMPLETED
Enrolment	1558
Start date	Wed Mar 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Ulcerative Colitis (UC)

Interventions

• risankizumab IV
• placebo for risankizumab
• risankizumab SC

Countries

Italy, Colombia, Japan, Malaysia, Taiwan, Poland, South Korea, Croatia, Denmark, New Zealand, Netherlands, Russia, Turkey (Türkiye), Belgium, Sweden, Mexico, Lithuania, Bulgaria, Portugal, United States, Latvia, France, South Africa, Slovakia, Greece, Serbia, Austria, Chile, Israel, Argentina