RECRUITINGPhase 3INTERVENTIONAL
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease
A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Mirikizumab
Administered IV or SC
Locations (20)
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
Columbia University Medical Center/New York Presbyterian
New York, New York, United States
Childrens Medical Center
Dayton, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Seattle Children's Hospital
Seattle, Washington, United States
AKH - Medizinische Universtität Wien
Vienna, Austria
Universitair Ziekenhuis Brussel
Brussels, Belgium
Cliniques universitaires Saint-Luc
Brussels, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium