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

• Status: Completed
• Trial end date: 2021-04-14
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

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, participants 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, participant must meet the contraception recommendations.

Exclusion Criteria:

• Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.

• Participants 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.

• Having an ostomy or ileoanal pouch.

• Known active Coronavirus Disease 2019 (COVID-19) infection.