Overview

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).