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

Completed · Phase 3

Conditions studied: Ulcerative Colitis, Ulcerative Colitis Chronic

In brief

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.

Key facts

Study ID

NCT05767021

Run by

Eli Lilly and Company

People needed

172

Starts

2023-05-17

Expected to finish

2026-04-27

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Digestive Health - Sun City — Sun City, Arizona, United States
• Om Research, LLC — Lancaster, California, United States
• California Medical Research Associates, Inc. — Northridge, California, United States
• Clinical Applications Laboratories, Inc. — San Diego, California, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Central Florida Gastro Research — Clearwater, Florida, United States
• Encore Borland-Groover Clinical Research — Jacksonville, Florida, United States
• Research Associates of South Florida — Miami, Florida, United States
• Advanced Research Associates, LLC — Miami, Florida, United States
• GCP Clinical Research, LLC — Tampa, Florida, United States
• International Center for Research LLC — Tampa, Florida, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Atlanta Center for Gastroenterology, P.C. — Decatur, Georgia, United States
• Grand Teton Research Group, PLLC — Idaho Falls, Idaho, United States
• IU Health University Hospital — Indianapolis, Indiana, United States
• Gastroenterology Health Partners — New Albany, Indiana, United States
• Cotton-O'Neil Clinical Research Center, Digestive Health — Topeka, Kansas, United States
• GI Alliance/ Metairie — Metairie, Louisiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• West Michigan Clinical Research Center — Wyoming, Michigan, United States
• NY Scientific — Brooklyn, New York, United States
• Digestive Health Partners - Research Department — Asheville, North Carolina, United States
• Dedicated Clinical Research — Litchfield Park, Arizona, United States

Full record on ClinicalTrials.gov

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