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



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.

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 Colitis, Ulcerative Ulcer Antibodies, Monoclonal risankizumab Substudy 1: Double-blind Risankizumab Dose 1 Substudy 1: Double-blind Risankizumab Dose 2 Substudy 2: Open-label Risankizumab Dose 1 Substudy 2: Open-label Risankizumab Dose 2 Substudy 3: Open-label Extension Risankizumab


You can join if…

Open to people ages 16-80

  • Participants who have completed Study M16-065 or 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 M16-065 or 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 M16-065 and M16-067


  • Ucsd /Id# 160430 accepting new patients
    La Jolla California 92093 United States
  • Southern California Res. Ctr. /ID# 169659 accepting new patients
    Coronado California 92118-1408 United States


accepting new patients
Start Date
Completion Date
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Phase 3
Study Type
Last Updated