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

Description

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

Crohn's Disease

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Crohn's Disease
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

San Francisco

University of California-San Francisco-Mission Bay, San Francisco, California, United States, 94158

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06032

Miami

Nicklaus Children's Hospital, Miami, Florida, United States, 33155

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Atlanta

Children's Center for Digestive Health Care, LLC, Atlanta, Georgia, United States, 30342

Indianapolis

Riley Childrens Hospital, Indianapolis, Indiana, United States, 46202

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Morristown

Atlantic Children's Health--Pediatric Gastroenterology, Morristown, New Jersey, United States, 07960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 must 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 as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) during screening into this study.
  • * 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.
  • * 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.

Ages Eligible for Study

2 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-10