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

Recruiting
18 - 80 years of age
Both
Phase 3

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Overview

This study is designed to evaluate the long-term efficacy and safety of mirikizumab in participants with moderately to severely active ulcerative colitis (UC). The study will last up to 3 years. Participants who complete the 3-year study may continue to receive mirikizumab until it is (outside of this study) in their country or until they meet other discontinuation criteria.

Eligibility

  • 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.

Study details

Ulcerative Colitis

NCT03519945

Eli Lilly and Company

2 May 2024

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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