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
ClinicalTrials.gov processed this data on August 27, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
ACTIVE, NOT RECRUITING (See Contacts and Locations)Verified August 2024 by Eli Lilly and Company
Sponsor
Eli Lilly and CompanyInformation Provided by (Responsible Party)
Eli Lilly and CompanyClinicaltrials.gov Identifier
NCT05767021Other Study ID Numbers: 18551
First Submitted: February 8, 2023
First Posted: March 14, 2023
Last Update Posted: August 28, 2024
Last Verified: August 2024
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Anticipated Enrollment | 160 participants |
| Design Allocation | N/A |
| Interventional Model | Single Group Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| Official Title | 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 |
| Study Start Date | May 17, 2023 |
| Actual Primary Completion Date | August 9, 2024 |
| Anticipated Study Completion Date | September 2025 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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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
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Eli Lilly and Company |
|---|---|
| Locations |
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| Investigators |
More Information
Additional Information
Additional Relevant MeSH Terms
- Colitis
- Colitis, Ulcerative
- Ulcer
- Gastroenteritis
- Gastrointestinal Diseases
- Digestive System Diseases
- Colonic Diseases
- Intestinal Diseases
- Pathologic Processes
- Inflammatory Bowel Diseases