Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase 2/3, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy

Keywords

Crohn Disease, Ozanimod

Eligibility

You can join if…

Open to people ages 2-17

  • 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

You CAN'T join if...

  • Participant is likely to require, in the physician's judgment, bowel resection within 12 weeks of entry into the study
  • 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
  • Participant has extensive small bowel resection (> 100 cm) or known diagnosis of short bowel syndrome or participant requires total parenteral nutrition

    Other protocol-defined inclusion/exclusion criteria apply.

Locations

  • UCSF Medical Center- Mission Bay accepting new patients
    San Francisco California 94158 United States
  • UC Davis Medical Center - UC Davis Medical Group - Pediatric Specialty Clinics accepting new patients
    Sacramento California 95817-2207 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT05470985
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated