A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

Study Overview
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Brief Summary
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A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.

Official Title
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A Multicenter, Phase 3b, Open-Label, Single-Arm Study to Investigate Bowel Urgency and Its Relationship With Other Outcome Measures in Adults With Moderately to Severely Active Ulcerative Colitis Treated With Mirikizumab

Conditions
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Ulcerative Colitis, Ulcerative Colitis Chronic

Intervention / Treatment
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* Drug: Mirikizumab
* Drug: Mirikizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have an established diagnosis of UC for ≥3 months Have confirmed diagnosis of moderately for severely active UC Have current bowel urgency Have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for UC. Exclusion Criteria: Have Crohn's disease (CD) Have inflammatory bowel disease-unclassified, formerly known as indeterminate colitis, or Have ulcerative proctitis, disease limited to the rectum, that is, distal to the recto-sigmoid junction, which lies approximately 10 to 15 centimeter (cm) from anal verge. Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation Have any history or current evidence of cancer of the gastrointestinal tract Have active tuberculosis Have HIV infection.

Ages Eligible for Study
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Minimum Age: 18 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>Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC). | Drug: Mirikizumab<br>* Administered IV<br>* Other names: LY3074828;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 |
| --- | --- | --- |
| Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS) |  | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Bowel Urgency Frequency |  | Baseline, Week 12 | 
| Percentage of Participants Achieving Clinically Meaningful Improvement in Bowel Urgency Frequency |  | Baseline to Week 12 | 
| Change from Baseline in Stool Deferral Time |  | Baseline, Week 12 | 
| Percentage of Participants Achieving Clinically Meaningful Improvement of Stool Deferral Time |  | Week 12 | 
| Percentage of Participants achieving Both Clinical Remission, Based on the modified Mayo Score and a UNRS score of ≤1 |  | Week 12 | 
| Percentage of Participants achieving Both Clinical Response, Based on the modified Mayo Score and a UNRS score ≥3 Points of Improvement from Baseline |  | Week 12 | 
| Pairwise Correlations between the UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures |  | Baseline to Week 12 | 
| Pairwise Correlations between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures |  | Baseline to Week 12 | 
| Correlation between the UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures, with Quality of Life (QoL)/Functional Outcome Measures and Ulcerative Colitis (UC) Symptom Measures |  | Baseline to Week 12 | 
| Correlation between Change in UNRS, Bowel Urgency Frequency, Stool Deferral Time, and Absorbent Product Use Measures, with Change in QoL/Functional Outcome Measures and UC Symptom Measures |  | Baseline to Week 12 |