jRCT2061230105RecruitingNot Applicable
[M23-784] 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
AbbVie G.K.0 sites276 target enrollmentStarted: March 12, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 276
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •Biopsy-confirmed diagnosis of CD for at least 3 months prior to Baseline.
- •Participant meets the following disease activity criteria:
- •Moderate to severe CD
- •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.
Investigators
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