LUCENT-URGE: A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mirikizumab Participants will receive mirikizumab intravenously (IV) and mirikizumab subcutaneously (SC). |
Drug: Mirikizumab
Administered IV
Other Names:
Drug: Mirikizumab
Administered SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Bowel Urgency Severity Urgency Numeric Rating Score (UNRS) [Baseline, Week 12]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have an established diagnosis of UC for ≥3 months
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Have confirmed diagnosis of moderately for severely active UC
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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.
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Have an inherited immunodeficiency syndrome or a monogenic cause of UC-like colonic inflammation
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Have any history or current evidence of cancer of the gastrointestinal tract
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Have active tuberculosis
-
Have HIV infection.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18551
- I6T-MC-AMBZ
- 2022-502393-16-00