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



The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2. The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis


Ulcerative Colitis (UC) ABBV-066 BI 655066 Colitis Colitis, Ulcerative Ulcer Antibodies, Monoclonal risankizumab IV risankizumab SC


You can join if…

Open to people ages 16-80

  • Male or female aged >=18 to <= 80 years at the Baseline Visit. Where locally permissible, subjects 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to Baseline.
  • Active UC as assessed by Adapted Mayo Score and Endoscopic Subscore.
  • Demonstrated intolerance or inadequate response to conventional therapy and tofacitinib (not a biologic) and one or more biologic therapies.
  • Females must be postmenopausal for more than 1 year or surgically sterile or practicing specific forms of birth control.

You CAN'T join if...

  • Participant with a current diagnosis of Crohn's disease (CD), inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis or ischemic colitis.
  • Participant receiving prohibited medications and treatment.
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
  • Participant with currently known complications of UC (e.g., megacolon).
  • No known active Coronavirus Disease - 2019 (COVID-19) infection.


  • UCSF Center for Colitis and Crohn's Disease /ID# 201210 accepting new patients
    San Francisco California 94115-3011 United States
  • Cedars-Sinai Medical Center-West Hollywood /ID# 163851 accepting new patients
    West Hollywood California 90048 United States
  • Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931 completed
    Los Angeles California 90067-2001 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 2/3 research study
Study Type
Expecting 1547 study participants
Last Updated