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BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID IM047-023  |   NCT05470985

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

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Summary

  • Phase 2/Phase 3
  • Male and Female Gender icon
  • 2-17
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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)
    1. Participant has an inadequate response, intolerance, or loss of response to at least 1 of the following treatments for Crohn's Disease (CD):
      1. corticosteroids
        1. immunomodulators
          1. biologic therapy
            1. other systemic immunomodulatory therapies for CD

            Exclusion Criteria

            Exclusion Criteria Icon
            :
            • Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
              1. Participant has current stoma, ileal-anal pouch anastomosis, fistula that is likely to require, in the physician's judgment, surgical or medical intervention within 12 weeks of entry into the study or need for ileostomy or colostomy
                1. Participant has extensive small bowel resection (> 100
                  1. or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition Other protocol-defined inclusion/exclusion criteria apply.
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Ozanimod Dose Level 1

                  ASSIGNED INTERVENTION
                  • Drug: Ozanimod

                  Study Arms

                  Experimental: Ozanimod Dose Level 2

                  ASSIGNED INTERVENTION
                  • Drug: Ozanimod

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