Have you or your loved ones been diagnosed with ulcerative colitis?

You may be eligible to participate in a ulcerative colitis clinical trial.

Have you or your loved ones been diagnosed with ulcerative colitis? You may be eligible to participate in a ulcerative colitis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Ulcerative Colitis Clinical Trial

NCT03519945 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with ulcerative colitis?

You may be eligible to participate in a ulcerative colitis clinical trial.

Have you or your loved ones been diagnosed with ulcerative colitis? You may be eligible to participate in a ulcerative colitis clinical trial.

Recruiting

Male & Female

18 - 80

Years old

This study is looking to recruit 960 Participants

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

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Details for the study

Brief Title

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

Official Title

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

Brief Summary

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

Treatments and/or Procedures

Mirikizumab

Administered SC.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Percentage of Participants in Clinical Remission

Clinical remission based on the modified Mayo Score (MMS).

Week 52

Secondary

Percentage of Participants Who Undergo UC Surgeries Including Colectomy

Participants who undergo UC surgeries including colectomy.

Baseline to Week 160

Secondary

Percentage of Participants Who are Hospitalized Due to UC

Participants who are hospitalized due to UC.

Baseline to Week 160

Secondary

Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score

Health Related Quality of Life based on IBDQ score.

Baseline to Week 52

Secondary

Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52

Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.

Week 52

Secondary

Percentage of Participants in Corticosteroid-free Remission

Participants in corticosteroid-free remission.

Week 52

Secondary

Percentage of Participants in Endoscopic Remission

Endoscopic remission based on the MMS Endoscopic Subscore (ES).

Week 52

Secondary

UC Symptoms: Numeric Rating Score

UC symptoms based on numeric rating score.

Week 160

Study 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.