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NCT05509777 · ClinicalTrials.gov registry record · Phase 3
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT05509777: Recruiting Phase 3 study of Crohn's Disease, sponsored by Eli Lilly and Company.
NCT05509777 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 90 participants, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05509777, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: * A 12-week induction period * A maintenance period from Week 12 to Week 52, and * A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.
Primary Outcome
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Conditions Studied
Interventions
- DRUG Mirikizumab
Study Locations (20)
Other
- AKH - Medizinische Universtität Wien - Vienna
- Universitair Ziekenhuis Brussel - Brussels
- Cliniques universitaires Saint-Luc - Brussels
- Universitair Ziekenhuis Gent - Ghent
- UZ Leuven - Leuven
New York
- Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) - New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Medical Center/New York Presbyterian - New York
Georgia
- Emory University - Atlanta
- Children's Center for Digestive Health Care, LLC - Atlanta
California
- Cedars Sinai Medical Center - Los Angeles
Connecticut
- Connecticut Children's Medical Center - Hartford
Indiana
- Riley Childrens Hospital - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
New Jersey
- Atlantic Children's Health--Pediatric Gastroenterology - Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2028-04 |
| Phase | Phase 3 |
What NCT05509777 shows while recruiting
NCT05509777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,394-participant average among 105 other Crohn's Disease trials with a reported enrollment target (96% 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.
NCT05509777 names 20 study sites across 13 states, led by Other, New York, Georgia.
Frequently Asked Questions
What is clinical trial NCT05509777 about?
NCT05509777 is a clinical study titled "A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease". Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn'...
What is the current status of trial NCT05509777?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2024-03-13. Estimated completion is 2028-04.
What conditions does trial NCT05509777 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT05509777?
The interventions under investigation include: Mirikizumab (DRUG).
Who is sponsoring clinical trial NCT05509777?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05509777 being conducted?
This trial has 20 study locations across California, Connecticut, Georgia, Indiana, Massachusetts. 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 NCT05509777's enrollment target sits among peer trials
90 72nd of 105 higher than 34 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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