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

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeannie Huang
Headshot of Jeannie Huang
Jeannie Huang

Description

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.

Official Title

A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease

Details

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

Keywords

Crohn's Disease, Inflammatory Bowel Disease, Crohn Disease, Mirikizumab

Eligibility

You can join if…

Open to people ages 2-17

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92093 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States
  • Cook Children's Medical Center accepting new patients
    Fort Worth Texas 76104 United States

Lead Scientist at UCSD

  • Jeannie Huang
    Dr. Jeannie Huang is Professor of Pediatrics at UC San Diego School of Medicine and Medical Director of the Inflammatory Bowel Disease Center at Rady Children's Hospital-San Diego. She is also a Physician Informaticist, Director of Continuing Medical Education at Rady Children's and Assistant Dean of Continuing Medical Education at UC San Diego.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease (AMAY)
ID
NCT05509777
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated
Contact us about this trial