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NCT03926130 · ClinicalTrials.gov registry record · Phase 3
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,158
- Enrollment target
- 20
- Study locations
NCT03926130: Completed Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.
NCT03926130 is a Phase 3 study of Crohn's Disease that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,158 participants, below the 2,384-participant average among 105 other Crohn's Disease trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03926130, a Phase 3 study of Crohn's Disease, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,158 participants
- Enrollment target
- 20
- Study locations
Study Summary
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
Primary Outcome
Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ustekinumab
- DRUG Mirikizumab
Study Locations (20)
California
- inSite Digestive Health Care - Arcadia
- B G Clinical Research, Inc. - Encinitas
- Care Access - Gilroy - Gilroy
- Newport Huntington Med Grp - Huntington Beach
- Om Research, LLC - Lancaster
- GastroIntestinal Biosciences Clinical Trials - Los Angeles
- California Medical Research Associates - Northridge
- University of California Irvine - Orange
- inSite Digestive Health Care - Pasadena
- Care Access Research - San Jose - San Jose
- Wolverine Clinical Trials, LLC - Santa Ana
Arizona
- Research Solutions of Arizona - Litchfield Park
- Central Arizona Medical Associates, PC - Mesa
- Arizona Arthritis & Rheumatology Research, PLLC - Phoenix
- Reliance Research - Scottsdale
- Synexus Site Network - Tempe
Alabama
- University of Alabama-The Kirklin Clinic - Birmingham
- Digestive Health Specialists - Dothan
- Lakeview Clinical Research - Guntersville
- Care Access Research - Tuscaloosa - Tuscaloosa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,158 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2023-10-02 |
| Phase | Phase 3 |
What the finished NCT03926130 record still lists
NCT03926130 is an interventional study that assigns participants to a tested intervention. Its 1,158 participants enrollment target places it among the larger protocols in the corpus, below the 2,384-participant average among 105 other Crohn's Disease trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03926130 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03926130 about?
NCT03926130 is a clinical study titled "A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease". The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
What is the current status of trial NCT03926130?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,158 participants. The study started on 2019-07-23. Estimated completion is 2023-10-02.
What conditions does trial NCT03926130 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT03926130?
The interventions under investigation include: Placebo (DRUG), Ustekinumab (DRUG), Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT03926130?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03926130 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. 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 NCT03926130's enrollment target sits among peer trials
1,158 8th of 105 higher than 98 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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