A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).
Trial Summary
Key Requirements
Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.Participants Must:
Participants must have completed study AMAN (NCT03518086), received study drug, and without early termination of study drug
Participants must be willing and able to complete the scheduled study assessments, including endoscopy and daily diary entry
Female participants must meet the contraception (birth control) requirements
Participants Must Not:
Participants must not have had surgery to remove part of the bowel or other surgery for the treatment of UC during the previous induction study AMAN (NCT03518086) and must not be likely to require surgery for the treatment of UC during study AMBG
Participants must not have evidence of abnormal cells in the colon or have been diagnosed with cancer of the gastrointestinal tract during study AMAN (NCT03518086)
Participants must not be 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 must not initiate a new medication that was not allowed during the induction study AMAN (NCT03518086)
Participants must not have certain laboratory abnormalities prior to start of AMBG that would require permanent discontinuation from study drug
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Clinical Trial Resources
You will complete the questionnaire on another website.YesNo