A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
About the study
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Have completed Study AMAN (NCT03518086), with at least 1 study drug administration and without early termination of study drug.
- Are willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry.
- If female, must meet the contraception requirements.
EXCLUSION CRITERIA
Exclusion Criteria:
- Participants diagnosed with Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) during the induction study AMAN (NCT03518086).
- Participants with a bowel resection or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086), or are likely to require surgery for the treatment of UC during study AMBG.
- Participants with evidence of colonic dysplasia or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086).
- Participants diagnosed with clinically important infection including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during the induction study AMAN (NCT03518086).
- Participants who initiate a new prohibited medication during the induction study AMAN (NCT03518086).
- Participants with certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug.
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
1177
Est. Completion Date
Jun 29, 2025
Treatment type
Interventional
Sponsor
Eli Lilly and Company
ClinicalTrials.gov identifier
NCT03524092
Study number
I6T-MC-AMBG
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