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

Stopped early · Phase 2/Phase 3

Conditions studied: Crohn Disease

In brief

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 facts

Study ID

NCT05470985

Run by

Bristol-Myers Squibb

People needed

5

Starts

2023-08-22

Expected to finish

2024-09-13

Last updated by the study team

2025-04-22

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Local Institution - 0010 — Garden Grove, California, United States
• Local Institution - 0028 — Los Angeles, California, United States
• Local Institution - 0002 — Sacramento, California, United States
• Local Institution - 0009 — San Francisco, California, United States
• Local Institution - 0011 — Hartford, Connecticut, United States
• Local Institution - 0044 — Orlando, Florida, United States
• Local Institution - 0037 — Orlando, Florida, United States
• Local Institution - 0053 — Atlanta, Georgia, United States
• Local Institution - 0059 — Indianapolis, Indiana, United States
• Local Institution - 0038 — Springfield, Massachusetts, United States
• Local Institution - 0006 — Detroit, Michigan, United States
• Local Institution - 0003 — Rochester, Minnesota, United States
• Local Institution - 0016 — St Louis, Missouri, United States
• Local Institution - 0071 — Lebanon, New Hampshire, United States
• Local Institution - 0060 — New York, New York, United States
• Local Institution - 0075 — Fort Worth, Texas, United States
• Local Institution - 0070 — Houston, Texas, United States
• Local Institution - 0008 — Seattle, Washington, United States
• Local Institution - 0040 — Tacoma, Washington, United States
• Local Institution - 0045 — Joonladup, Western Australia, Australia
• Local Institution - 0058 — Brussels, BRU, Belgium
• Local Institution - 0023 — Leuven, VBR, Belgium
• Local Institution - 0048 — Liège, WLG, Belgium
• Local Institution - 0062 — Liège, WLG, Belgium
• Local Institution - 0047 — Brussels, Belgium

Full record on ClinicalTrials.gov

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