A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2025-02-28
• Target enrollment: 0
• Participant gender: All

Summary

A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.

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

Details

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

Criteria

Inclusion Criteria:

• Have an established diagnosis of UC for ≥3 months

• Have confirmed diagnosis of moderately for severely active UC

• Have current bowel urgency

• Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC.

Exclusion Criteria:

• Have Crohn's disease (CD)

• Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or

• Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge.

• Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation

• Have any history or current evidence of cancer of the gastrointestinal tract

• Have active tuberculosis

• Have HIV infection.