Mirikizumab for Ulcerative Colitis (LUCENT-URGE Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a medication called mirikizumab, which aims to reduce bowel urgency in adults with severe ulcerative colitis. The medication works by calming the immune system to reduce inflammation in the intestines. The study will last for several months and include multiple phases.

Eligibility Criteria

This trial is for adults with moderately to severely active ulcerative colitis who have had it for at least 3 months. They should be experiencing bowel urgency and not responding well to conventional or certain advanced therapies. People with Crohn's disease, limited rectal disease, gastrointestinal cancer history, tuberculosis, HIV, or specific immunodeficiency syndromes cannot join.

Treatment Details

The study tests Mirikizumab's effect on bowel urgency in people with moderate to severe ulcerative colitis. It spans over 36 weeks and includes four different periods of assessment to understand how well the treatment works.

1Treatment groups

Experimental Treatment

Group I: MirikizumabExperimental Treatment1 Intervention

Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).

Mirikizumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Omvoh for: