for people ages 16-80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects 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 subjects who completed Substudy 1 or 2.

Official Title

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 Who Responded to Induction Treatment in M16-067 or M16-065


Ulcerative Colitis (UC) ABBV-066 BI 655066 Colitis Ulcer Colitis, Ulcerative risankizumab Substudy 2: Open-label Risankizumab Dose 1 Substudy 1: Double-blind Risankizumab Dose 2 Substudy 2: Open-label Risankizumab Dose 2 Substudy 3: Open-label Extension Risankizumab Substudy 1: Double-blind Risankizumab Dose 1


You can join if…

Open to people ages 16-80

  • Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response

You CAN'T join if...

  • Subjects 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 M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study
  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067


  • UCSF Center for Colitis and Crohn's Disease /ID# 201209 not yet accepting patients
    San Francisco California 94115-3011 United States
  • Univ of California San Francis /ID# 160565 not yet accepting patients
    San Francisco California 94158 United States


accepting new patients
Start Date
Completion Date
Phase 3
Study Type
Last Updated