RECRUITING

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

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Conditions

Crohn's DiseaseInflammatory Bowel Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-13
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05509777

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.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Participants must have moderately to severely active CD (as defined by a baseline PCDAI score \>30).
  3. * 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.
  4. * 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.
  1. * 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.
  2. * Participants must not have an abscess.
  3. * Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559
ClinicalTrials.gov@lilly.com

Principal Investigator

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 Locations (Sites)

University of California San Diego
La Jolla, California, 92093
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of California-San Francisco-Mission Bay
San Francisco, California, 94158
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06032
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
Emory University
Atlanta, Georgia, 30322
United States
Children's Center for Digestive Health Care, LLC
Atlanta, Georgia, 30342
United States
Riley Childrens Hospital
Indianapolis, Indiana, 46202
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Atlantic Children's Health--Pediatric Gastroenterology
Morristown, New Jersey, 07960
United States
Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC)
New York, New York, 10021-5663
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center/New York Presbyterian
New York, New York, 10032
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Childrens Medical Center
Dayton, Ohio, 45404
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-13
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-03-13
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Inflammatory Bowel Disease

Additional Relevant MeSH Terms

  • Crohn's Disease