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About
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
Enrollment
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Inclusion criteria
Participants must have a Pediatric Crohn's Disease Activity Index (PCDAI) score ≥ 30 and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD):
i) corticosteroids ii) immunomodulators iii) biologic therapy iv) other systemic immunomodulatory therapies for CD
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
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Central trial contact
BMS Study Connect Contact Center http://www.bmsstudyconnect.com; First line of the email MUST contain NCT # and Site #.
Data sourced from clinicaltrials.gov
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