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 or can transition to a Continued Treatment for Trial Participants Open-Label Extension study.
A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis
Ulcerative Colitis (UC), ABBV-066, BI 655066, Colitis, Ulcerative Colitis, Ulcer, Monoclonal Antibodies, risankizumab, Substudy 2: OL Therapeutic Drug Monitoring Risankizumab, Substudy 3: OL Extension Risankizumab
You can join if…
Open to people ages 16-80
Participants who have completed Study M16-067 and have achieved clinical response as defined in the protocol.
You CAN'T join if...
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.
UCSF Center for Colitis and Crohn's Disease /ID# 201209 San Francisco California 94115-3011 United States
Cedars-Sinai Medical Center-West Hollywood /ID# 163848 West Hollywood California 90048 United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934 Los Angeles California 90067-2001 United States