A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

NCT05509777 · tracked via the Priya Life Science USA tracker

Sponsor

Eli Lilly and Company

Phase

Phase 3

Started

2024-03-13

Last updated

2026-08-24

Condition(s) studied

Crohn's Disease

Investigational drug(s) / intervention(s)

Mirikizumab

Mirikizumab: Administered IV or SC

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.

Eligibility

Sex

ALL

Min age

2 Years

Max age

17 Years

Healthy volunteers

Inclusion Criteria: * Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria. * Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30). * Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0. * Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor. Exclusion Criteria: * Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery. * Participants must not have an abscess. * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Primary outcome measure(s)

Percentage of Participants with Clinical Response by Pediatric Crohn's Disease Activity Index (PCDAI) at Week 12 and Endoscopic Response by Simple Endoscopic Score for CD (SES-CD) at Week 52 — Baseline to Week 52
Clinical response based on PCDAI, and endoscopic response based on SES-CD.
Percentage of Participants with a Clinical Response by PCDAI at Week 12 and Clinical Remission by PCDAI at Week 52 — Baseline to Week 52
Clinical response based on PCDAI, and clinical remission based on PCDAI.

Trial sites (81)

Facility	City	Region	Status
Cedars Sinai Medical Center	Los Angeles	California	Not Yet Recruiting
Connecticut Children's Medical Center	Hartford	Connecticut	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Children's Center for Digestive Health Care, LLC	Atlanta	Georgia	Recruiting
Riley Childrens Hospital	Indianapolis	Indiana	Recruiting
Boston Children's Hospital	Boston	Massachusetts	Not Yet Recruiting
Atlantic Children's Health--Pediatric Gastroenterology	Morristown	New Jersey	Not Yet Recruiting
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)	New York	New York	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Columbia University Medical Center/New York Presbyterian	New York	New York	Recruiting
Childrens Medical Center	Dayton	Ohio	Recruiting
Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	Recruiting
Cook Children's Medical Center	Fort Worth	Texas	Recruiting
University of Vermont Medical Center	Burlington	Vermont	Recruiting
Seattle Children's Hospital	Seattle	Washington	Not Yet Recruiting
AKH - Medizinische Universtität Wien	Vienna	Austria	Recruiting
Universitair Ziekenhuis Brussel	Brussels	Belgium	Recruiting
Cliniques universitaires Saint-Luc	Brussels	Belgium	Recruiting
Universitair Ziekenhuis Gent	Ghent	Belgium	Recruiting
UZ Leuven	Leuven	Belgium	Recruiting
Hospital PUC-CAMPINAS	Campinas	Brazil	Recruiting
Hospital Pequeno Príncipe	Curitiba-PR	Brazil	Recruiting
Hospital das Clínicas - UFG (Universidade Federal de Goiás)	Goiânia	Brazil	Recruiting
Hospital de Clínicas de Porto Alegre	Porto Alegre	Brazil	Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre	Porto Alegre	Brazil	Recruiting
NDI - Nucleo de Doenças Infecciosas	Santos Dumont	Brazil	Recruiting
Integral Pesquisa e Ensino	Votuporanga	Brazil	Recruiting
IWK Health Centre	Halifax	Canada	Recruiting
London Health Sciences Centre (LHSC) - Victoria Hospital	London	Canada	Recruiting
The Hospital for Sick Children	Toronto	Canada	Recruiting
Children's & Women's Health Centre of British Columbia	Vancouver	Canada	Not Yet Recruiting
URC CIC	Paris	France	Terminated
Soroka Medical Center	Beersheba	Israel	Recruiting
Shamir Medical Center (Assaf Harofeh)	Israel	Israel	Recruiting
Shaare Zedek	Jerusalem	Israel	Recruiting
Hadassah University Hospital, Ein Kerem,	Jerusalem	Israel	Recruiting
Schneider Children's Medical Center	Petah Tikva	Israel	Recruiting
Kaplan Medical Center, Pediatric Gastroenterology Dept.	Rehovot	Israel	Not Yet Recruiting
Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e C. Arrigo	Alessandria	Italy	Not Yet Recruiting
Asst Papa Giovanni Xxiii Bergamo	Bergamo	Italy	Recruiting

+ 41 more sites — see the full list on the official registry below.

On this site

📄 Omvoh (mirikizumab) drug profile →

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Other trials for the same condition

A Study to Assess Adverse Events and Change in Disease Activity of Risankizumab Subcutaneous Induction Treatment for Moderately to Severely Active Crohn's Disease. Active, not recruiting

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease Recruiting

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON) Recruiting

A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting

A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05509777 on ClinicalTrials.gov ↗ ← All trials in the USA