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A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
NCT05509777 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05509777
The ClinicalTrials.gov registry entry for NCT05509777 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05509777 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, New York, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05509777?
The interventions under investigation include: Mirikizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05509777?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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