What is the Purpose of this Study?
The purpose of this study is to determine whether the experimental drugs guselkumab and mirikizumab work in patients with moderate to severe Crohn’s disease (CD) who are 2 to 17 years old and have not responded to currently available treatment(s) for CD. Guselkumab and mirikizumab block interleukin-23 (IL-23), a protein in the body that causes an inflammatory response. Participants will be randomly assigned to receive either guselkumab or mirikizumab. Study procedures also include physical exam, blood and urine testing, electrocardiogram, and completion of questionnaires.
Eligibility
- * 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.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohns Disease