NCT03398135
Brief summary
The purpose of this study is to evaluate safety and efficacy of an active drug in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with an active drug in a prior AbbVie study of an active drug 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 subjects who completed Substudy 1 or 2.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 16 Years to 80 Years.
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.
