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

Phase 3
Recruiting
Conditions
Crohn's Disease
Interventions
Registration Number
NCT05509777
Lead Sponsor
Eli Lilly and Company
Brief 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.

Detailed Description

Participants screened in the MACARONI-23 Platform study could be randomized to mirikizumab to participate in this intervention specific arm of the study.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mirikizumab Dose 1MirikizumabMirikizumab administered intravenously (IV) or subcutaneously (SC) in participants that weigh greater than (\>) 40 kilograms (kg).
Mirikizumab Dose 2MirikizumabMirikizumab administered IV or SC in participants that weigh \>20 kg to less than or equal to (≤) 40 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.
Mirikizumab Dose 3MirikizumabMirikizumab administered IV or SC in participants that weigh greater than or equal to (≥) 9 kg to less than or equal to ≤20 kg. Dosing is based on assessments of the participant's weight and appropriate weight class.
Primary Outcome Measures
NameTimeMethod
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 52Baseline 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 52Baseline to Week 52

Clinical response based on PCDAI, and clinical remission based on PCDAI.

Secondary Outcome Measures
NameTimeMethod
Change from Baseline in C-reactive Protein (CRP)Baseline, Week 12
Pharmacokinetics (PK): Clearance of MirikizumabBaseline through Week 52
Pharmacokinetics (PK): Volume of Distribution of MirikizumabBaseline through Week 52
Change from Baseline in CRPBaseline, Week 52
Percentage of Participants Achieving Clinical Response by PCDAIWeek 12

Clinical response based on PCDAI.

Percentage of Participants Achieving Clinical Response by Clinical Disease Activity Index (CDAI)Week 12

Clinical response based on CDAI for participants ≥12 years of age

Percentage of Participants Achieving Clinical Remission by PCDAIWeek 52

Clinical remission based on PCDAI

Percentage of Participants Achieving Clinical Remission by CDAIWeek 12

Clinical remission based on CDAI for participants ≥12 years of age.

Percentage of Participants Achieving Endoscopic Response by SES-CDWeek 12

Endoscopic response based on SES-CD.

Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and Endoscopic Remission by SES-CD at Week 52Baseline to Week 52
Change from Baseline in Fecal calprotectinBaseline, Week 52
Percentage of Participants Achieving Clinical Response PCDAI at Week 12 and Clinical Remission by CDAI at Week 52Baseline to Week 52

Clinical response by PCDAI, CDAI for participants ≥12 years of age

Percentage of Participants Achieving Endoscopic ResponseWeek 52

Endoscopic response by SES-CD

Percentage of Participants Achieving Clinical Response by PCDAI at Week 12 and PCDAI Clinical Remission without the use of Corticosteroids and who did not have Crohn's disease (CD)-Related Surgery at Week 52Baseline to Week 52

Clinical response and clinical remission by PCDAI

Trial Locations

Locations (83)

University of California San Diego

🇺🇸

La Jolla, California, United States

Cedars Sinai Medical Center

🇺🇸

Los Angeles, California, United States

Connecticut Children's Medical Center

🇺🇸

Hartford, Connecticut, United States

Emory University

🇺🇸

Atlanta, Georgia, United States

Children's Center for Digestive Health Care, LLC

🇺🇸

Atlanta, Georgia, United States

Riley Childrens Hospital

🇺🇸

Indianapolis, Indiana, United States

Boston Children's Hospital

🇺🇸

Boston, Massachusetts, United States

Atlantic Children's Health--Pediatric Gastroenterology

🇺🇸

Morristown, New Jersey, United States

Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)

🇺🇸

New York, New York, United States

Icahn School of Medicine at Mount Sinai

🇺🇸

New York, New York, United States

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University of California San Diego
🇺🇸La Jolla, California, United States
Jeannie Huang
Principal Investigator

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