A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
Phase 3 – large-scale trial before approval
Conditions:
Ulcerative Colitis (UC)
Sponsor: AbbVie
trial.available_in:
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Overview
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.
This study consists of three sub-studies and a Continuous Treatment Extension (CTE): Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic or due to the geopolitical conflict in Ukraine and surrounding impacted regions. The CTE is an open-label extension for Substudy 3 completers to ensure continuous treatment with risankizumab until such time that risankizumab becomes commercially available and/or the subject can access treatment locally.
Who can participate
Inclusion Criteria:
\- Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
Exclusion Criteria:
* Participants who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-067 that in the Investigator's judgment makes the participant unsuitable for this study.
* Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
* Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-067.
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