A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Risankizumab Subcutaneous Induction Treatment in Subjects With Moderately to Severely Active Crohn's Disease

M23-784

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective risankizumab subcutaneous (SC) induction treatment is in treating moderately to severely active CD in adult participants. Risankizumab is an approved drug for adults with CD. This study comprises of a Period A and a Period B. In Period A, participants are placed in 1 of 2 groups to receive either risankizumab SC or Placebo. In Period B, based on response, participants will receive risankizumab SC Dose B or Placebo. Participants who do not have improvement in CD symptoms at Week 12 will receive risankizumab SC Dose C and participants with worsening CD symptoms in period B will receive risankizumab SC. Approximately 276 adult participants with a diagnosis of moderately to severely active CD will be enrolled in approximately 250 sites globally. Participants will receive SC induction treatment of risankizumab or matching placebo for up to 24 weeks in Period A and B. The duration of the study will be approximately 49 weeks.

2023-11-15

2026-03-27

2028-02-23

Recruiting

Early phase I

276

Inclusion Criteria: * Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline. * Participant meets the following disease activity criteria: 1. Moderate to severe CD as assessed by COAi 2. Endoscopic evidence of mucosal inflammation as documented by a SES-CD * Participant has demonstrated intolerance, loss of response or inadequate response to conventional or advanced therapies for CD. Exclusion Criteria: * Participants with a current diagnosis of ulcerative colitis or indeterminate colitis. * Participants with unstable doses of concomitant Crohn's disease therapy. * Participants with prior exposure to p19 inhibitors. * Participants with complications of Crohn's disease. * Participants having an ostomy or ileoanal pouch.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 276, 'type': 'ESTIMATED'}}

2024-06-07