Active — Not RecruitingPhase 3

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

United States1,058 participantsStarted 2018-07-18

Plain-language 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). 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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.

What they're measuring

Percentage of Participants in Clinical Remission

Timeframe: Week 52

Trial details

NCT IDNCT03519945

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-04

View on ClinicalTrials.gov More Ulcerative Colitis trials