A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

• Status: Recruiting
• Trial end date: 2024-04-16
• Target enrollment: 0
• Participant gender: All

Summary

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Mirikizumab; Ustekinumab

Criteria

Inclusion Criteria:

• Diagnosis of CD for at least 3 months prior to baseline

• Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD

• Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD

• If female, subject must meet the contraception recommendations

Exclusion Criteria:

• Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome

• Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery

• Have a stoma, ileoanal pouch or ostomy

• Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline

• Have ever received any monoclonal antibodies binding IL-23