Actively Recruiting
A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Treatments for Adults With Moderately to Severely Active Ulcerative Colitis or Crohns Disease
Led by Eli Lilly and Company · Updated on 2026-06-04
60
Participants Needed
72
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new treatments for adults with moderately to severely active ulcerative colitis or Crohns disease through a master protocol called IIBD. This protocol supports multiple individual sub-studies with shared design features, aiming to assess the effectiveness and safety of these treatments over at least 62 weeks. Participants are assigned to the appropriate study before being randomly placed into treatment groups. The study includes two main treatment periods. In one group, participants receive mirikizumab intravenously during the first period, and responders then receive mirikizumab subcutaneously in the second period. Another group receives a combination of oral LY4395089 and intravenous mirikizumab initially, with responders later stopping LY4395089 and continuing with mirikizumab subcutaneously. These treatments are being compared to understand their effects better. Participants will undergo assessments including clinical evaluations, endoscopic examinations, and laboratory tests to confirm disease activity and monitor response. The primary measurement is the number of participants allocated to each treatment appendix during the first 42 days. The study also tracks safety and treatment response over the course of at least 62 weeks, with ongoing evaluations to gather comprehensive data on these interventions.
CONDITIONS
Brief Title
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Established diagnosis of ulcerative colitis or Crohn's disease for at least 3 months
- For ulcerative colitis: Moderately to severely active disease with a modified Mayo score of 5-9 and endoscopic subscore 2; 2, with rectal bleeding of at least 1
- For Crohn's disease: Moderately to severely active disease with a Crohn's disease activity index score between 220 and 450 and specific endoscopic scores confirmed within 21 days before randomization
- Inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, or advanced therapy for ulcerative colitis or Crohn's disease
- Screening laboratory tests within protocol-specified parameters
You will not qualify if you...
- Current diagnosis of inflammatory bowel disease-unclassified or primary sclerosing cholangitis
- For ulcerative colitis participants: Current diagnosis of Crohn's disease
- For Crohn's disease participants: Current diagnosis of ulcerative colitis
- History of or need for bowel resection or intestinal or intra-abdominal surgery as specified in the protocol
- Complications such as stricture, stenosis (with some exceptions for Crohn's disease), or short bowel syndrome
- Significant uncontrolled illness that may affect safety or data interpretation
- Failure of more than 5 approved advanced treatments with different mechanisms of action
- Failure of anti-interleukin-23p19 antibody treatment
- Use of prohibited medications for ulcerative colitis or Crohn's disease as specified in the protocol
Research Team
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There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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