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NCT05767021 · ClinicalTrials.gov registry record · Phase 3
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis and Ulcerative Colitis Chronic, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
- 20
- Study locations
NCT05767021: Active Phase 3 study of Ulcerative Colitis and Ulcerative Colitis Chronic, sponsored by Eli Lilly and Company.
NCT05767021 is a Phase 3 study of Ulcerative Colitis and Ulcerative Colitis Chronic that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 172 participants, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05767021, a Phase 3 study of Ulcerative Colitis and Ulcerative Colitis Chronic, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The UNRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Baseline Observation Carried Forward (BOCF) endpoint was defined as the baseline value for participants discontinued during acute phase and defined as the last non-missing observation in the treatment phase for
Conditions Studied
Interventions
- DRUG Mirikizumab
Study Locations (20)
Florida
- Central Florida Gastro Research - Clearwater
- Encore Borland-Groover Clinical Research - Jacksonville
- Research Associates of South Florida - Miami
- Advanced Research Associates, LLC - Miami
- GCP Clinical Research, LLC - Tampa
- International Center for Research LLC - Tampa
California
- Om Research, LLC - Lancaster
- California Medical Research Associates, Inc. - Northridge
- Clinical Applications Laboratories, Inc. - San Diego
Arizona
- Dedicated Clinical Research - Litchfield Park
- Arizona Digestive Health - Sun City - Sun City
Georgia
- Digestive Healthcare of Georgia - Atlanta
- Atlanta Center for Gastroenterology, P.C. - Decatur
Indiana
- IU Health University Hospital - Indianapolis
- Gastroenterology Health Partners - New Albany
Louisiana
- GI Alliance/ Metairie - Metairie
- Delta Research Partners - Monroe
Connecticut
- Medical Research Center of Connecticut, LLC - Hamden
Idaho
- Grand Teton Research Group, PLLC - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2023-05-17 |
| Est. Completion | 2026-04 |
| Phase | Phase 3 |
What the registry record for NCT05767021 still lists
NCT05767021 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 2,056-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Mirikizumab is the first listed.
NCT05767021 names 20 study sites across 9 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05767021 about?
NCT05767021 is a clinical study titled "A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis". 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.
What is the current status of trial NCT05767021?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2023-05-17. Estimated completion is 2026-04.
What conditions does trial NCT05767021 study?
This clinical trial studies the following conditions: Ulcerative Colitis, Ulcerative Colitis Chronic.
What interventions are being tested in trial NCT05767021?
The interventions under investigation include: Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT05767021?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05767021 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05767021's enrollment target sits among peer trials
172 48th of 122 higher than 75 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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