A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

• Status: Enrolling by invitation
• Trial end date: 2024-05-23
• Target enrollment: 0
• Participant gender: All

Summary

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: 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

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.