An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
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.
- Ulcerative Colitis
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- 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).
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Double (Participant, Investigator)
|Mirikizumab administered intravenously (IV).||
|Placebo administered IV.||
- NCT ID
- Eli Lilly and Company
Study ContactThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or