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NCT04232553 · ClinicalTrials.gov registry record · Phase 3
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 996
- Enrollment target
- 20
- Study locations
NCT04232553: Active Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.
NCT04232553 is a Phase 3 study of Crohn's Disease that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 996 participants, below the 2,385-participant average among 105 other Crohn's Disease trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04232553, a Phase 3 study of Crohn's Disease, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 996 participants
- Enrollment target
- 20
- Study locations
Study Summary
The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
Primary Outcome
Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 indivi
Conditions Studied
Interventions
- DRUG Mirikizumab
Study Locations (20)
Florida
- Gastroenterology Consultants of Clearwater - Clearwater
- Clinical Research of West Florida, Inc. (Clearwater) - Clearwater
- IHS Health Research - Kissimmee
- Ezy Medical Research - Miami
- Care Access - Orlando - Orlando
- Gastroenterology Associates of Pensacola, PA - Pensacola
- Precision Clinical Research - Sunrise
- USF Health - Tampa
- Alliance Clinical Research of Tampa - Tampa
California
- Care Access - Gilroy - Gilroy
- Newport Huntington Medical Group - Huntington Beach
- California Medical Research Associates - Northridge
Arizona
- Research Solutions of Arizona - Litchfield Park
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
Georgia
- Digestive Healthcare of Georgia - Atlanta
- Gastrointestinal Specialists of Georgia - Marietta
Alabama
- Digestive Health Specialists - Dothan
Connecticut
- Connecticut Clinical Research Institute - Bristol
Idaho
- Grand Teton Research Group - Idaho Falls
Indiana
- Qualmedica Research, LLC - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 996 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What the registry record for NCT04232553 still lists
NCT04232553 is an interventional study that assigns participants to a tested intervention. The registered 996 participants enrollment target is mid-sized for trials with a published cap, below the 2,385-participant average among 105 other Crohn's Disease trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Mirikizumab is the first listed.
NCT04232553 names 20 study sites across 8 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04232553 about?
NCT04232553 is a clinical study titled "A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease". The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.
What is the current status of trial NCT04232553?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 996 participants. The study started on 2020-06-22. Estimated completion is 2027-04.
What conditions does trial NCT04232553 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT04232553?
The interventions under investigation include: Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT04232553?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04232553 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
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 NCT04232553's enrollment target sits among peer trials
996 9th of 105 higher than 97 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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