A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    960
  • sponsor
    Eli Lilly and Company
Updated on 21 July 2021
mirikizumab

Summary

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC).

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Mirikizumab
Clinical Study IdentifierNCT03519945
SponsorEli Lilly and Company
Last Modified on21 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug
Female participants must agree to contraception requirements

Exclusion Criteria

Participants must not have developed a new condition, including cancer in the originator study
Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study
Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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