Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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 or due to the geopolitical
conflict in Ukraine and surrounding impacted regions.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Gastrointestinal, Stomach, Esophageal
Enrollment Eligibility
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.