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Evaluating the long-term effects of mirikizumab for ulcerative colitis

A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3

PHASE3 · Eli Lilly and Company · NCT03519945

This study is testing how well and safely mirikizumab works for people with moderate to severe ulcerative colitis over three years.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment1063 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorEli Lilly and Company (industry)
Drugs / interventionsmirikizumab
Locations362 sites (Dothan, Alabama and 361 other locations)
Trial IDNCT03519945 on ClinicalTrials.gov

What this trial studies

This study aims to assess the long-term efficacy and safety of mirikizumab in individuals suffering from moderately to severely active ulcerative colitis over a period of up to three years. Participants who complete the study may continue receiving mirikizumab until it becomes available outside the study or until they meet specific discontinuation criteria. The study includes participants from previous studies who have received at least one dose of the study drug and have not experienced early termination. The focus is on monitoring the drug's effectiveness and safety profile in a real-world setting.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with moderately to severely active ulcerative colitis who have participated in prior related studies.

Not a fit: Patients who have developed new conditions or significant infections, or who have undergone surgery for ulcerative colitis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new long-term treatment option for patients with ulcerative colitis, improving their quality of life.

How similar studies have performed: Other studies have shown promise with similar biologic treatments for ulcerative colitis, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
* 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.

Where this trial is running

Dothan, Alabama and 361 other locations

+312 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ulcerative Colitis, Inflammatory Bowel Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.