Last updated on August 2020

A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Crohn's Disease | Inflammatory bowel disease | Crohn's Disease (Pediatric)
  • Age: Between 16 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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 conventional or to biologic therapy for CD
  • If female, subject must meet the contraception recommendations

Exclusion Criteria:

  • 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 (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab)
  • Complications of Crohn's disease (strictures, stenosis, short bowel, etc)
  • Having an ostomy or ileoanal pouch

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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