An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

• Status: Recruiting
• Trial end date: 2022-10-08
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of UC for at least 3 months prior to baseline.

• Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).

• Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.

• If female, must meet the contraception requirements.

Exclusion Criteria:

• Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).

• Participants with a previous colectomy.

• Participants with current evidence of toxic megacolon.

• Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).