An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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).
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Ulcerative Colitis
Age (in years)
18 - 80
Phase
Phase 3
Participants needed
1281
Est. Completion Date
Sep 22, 2024
Treatment type
Interventional
Sponsor
Eli Lilly and Company
ClinicalTrials.gov identifier
NCT03518086
Study number
I6T-MC-AMAN
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