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



The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in subjects with moderately to severely active CD.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment


Crohn's Disease ABBV-066 BI 655066 Crohn Disease risankizumab SC risankizumab IV


You can join if…

Open to people ages 16-80

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, 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
  • Diagnosis of CD for at least 3 months prior to Baseline
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD)
  • Demonstrated intolerance or inadequate response to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

You CAN'T join if...

  • Subject with a current diagnosis of ulcerative colitis or indeterminate colitis
  • Subjects with unstable doses of concomitant Crohn's disease therapy
  • Receipt of Crohn's disease approved biologic agents (within 8 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days prior to the Baseline
  • Prior exposure to p40 inhibitors (e.g., ustekinumab [Stelara]) or p19 inhibitors(e.g., risankizumab)
  • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch


  • University of California, San /ID# 157116 not yet accepting patients
    San Francisco California 94158 United States
  • Gastrointestinal Biosciences /ID# 162655 not yet accepting patients
    Los Angeles California 90067-2001 United States

Lead Scientist

  • Melvin Heyman
    Authored (or co-authored) 143 research publications


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