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

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

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Mirikizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirikizumab<br>Mirikizumab administered subcutaneously (SC). | Drug: Mirikizumab<br>* Administered SC.<br>* Other names: LY3074828;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Clinical Remission | Clinical remission based on the modified Mayo Score (MMS). | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Endoscopic Remission | Endoscopic remission based on the MMS Endoscopic Subscore (ES). | Week 52 | 
| Percentage of Participants in Corticosteroid-free Remission | Participants in corticosteroid-free remission. | Week 52 | 
| 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 | 
| Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score | Health Related Quality of Life based on IBDQ score. | Baseline to Week 52 | 
| UC Symptoms: Numeric Rating Score | UC symptoms based on numeric rating score. | Week 160 | 
| Percentage of Participants Who are Hospitalized Due to UC | Participants who are hospitalized due to UC. | Baseline to Week 160 | 
| Percentage of Participants Who Undergo UC Surgeries Including Colectomy | Participants who undergo UC surgeries including colectomy. | Baseline to Week 160 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease