for people ages 18-80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Melvin Heyman
Photo of Melvin Heyman
Melvin Heyman



The study consists of 3 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991 - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 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 Crohn's Disease


Crohn's Disease risankizumab ABBV-066 BI 655066 Crohn Disease Antibodies, Monoclonal Risankizumab IV Risankizumab SC Double-blind Risankizumab Dose 1 (Sub-Study 1) Double-blind Risankizumab Dose 2 (Sub-Study 1) Maintenance Risankizumab Dose 1 (Sub-Study 2) Maintenance Risankizumab Dose 2 (Sub-Study 2) Open-label Risankizumab (Sub-Study 3)


You can join if…

Open to people ages 18-80

  • Participants who have entered and completed Study M16-006 or Study M15-991 or Study M15-989.
  • Participants have completed the study M16-006 or M15-991 and have achieved clinical response.

You CAN'T join if...

  • Participant is considered by the Investigator, for any reason, to be an unsuitable candidate for the study .
  • Participant who has 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 M16-006, M15-991 or M15-989 that in the Investigator's judgment makes the participant unsuitable for this study.
  • Participant is not in compliance with prior and concomitant medication requirements throughout Studies M16-006, M15-991 or M15-989.
  • Confirmed positive urine pregnancy test at the Final Visit of Study M16-006, Study M15-991 or Study M15-989.
  • Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
  • Any active or chronic recurring infections based on the Investigator's assessment makes the participant an unsuitable candidate for the study.


  • University of California, San Francisco - 16th St /ID# 157127
    San Francisco California 94158 United States
  • TLC Clinical Research Inc /ID# 212719
    Los Angeles California 90048 United States
  • Cedars-Sinai Medical Center - West Hollywood /ID# 163839
    West Hollywood California 90048 United States
  • Gastrointestinal Biosciences /ID# 162657
    Los Angeles California 90067-2001 United States

Lead Scientist at UCSF

  • Melvin Heyman
    Professor, Pediatrics. Authored (or co-authored) 315 research publications.


accepting new patients by invitation only
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