Completed Enrollment

A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

I6T-MC-AMBG -

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

Age Range
18 - 80 years
Conditions the trial is for
Ulcerative Colitis
What the trial is testing?
Mirikizumab, Placebo
Could I receive a Placebo?
Yes
Enrollment Goal
1177
Trial Dates
Oct 19, 2018 - Dec 2024
How long will I be in the trial?
The study will last about 40 weeks and may include up to 11 visits.
Trial Phase
III

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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