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

Phase 3

Active, not recruiting

• Conditions: Ulcerative Colitis; Ulcerative Colitis Chronic
• Interventions: Drug: Mirikizumab

• Registration Number: NCT05767021
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-14
• Study Start: 2023-05-17
• Primary Completion: 2024-08-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mirikizumab	Mirikizumab	Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS)	Baseline, Week 12

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (120)

Dedicated Clinical Research; 🇺🇸 Litchfield Park, Arizona, United States

Arizona Digestive Health - Sun City; 🇺🇸 Sun City, Arizona, United States

Om Research, LLC; 🇺🇸 Lancaster, California, United States

California Medical Research Associates, Inc.; 🇺🇸 Northridge, California, United States

Clinical Applications Laboratories, Inc.; 🇺🇸 San Diego, California, United States

Medical Research Center of Connecticut, LLC; 🇺🇸 Hamden, Connecticut, United States

Central Florida Gastro Research; 🇺🇸 Clearwater, Florida, United States

Encore Borland-Groover Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Research Associates of South Florida; 🇺🇸 Miami, Florida, United States

Advanced Research Associates, LLC; 🇺🇸 Miami, Florida, United States

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