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Sphingosine 1-phosphate receptor modulator

Ozanimod for Pediatric Crohn's Disease

Phase 2 & 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will study if ozanimod is effective, safe, and has desired drug levels and effects in children with Crohn's Disease.

Who is the study for?
This trial is for children with moderate to severe Crohn's Disease who haven't responded well to treatments like steroids, immunomodulators, biologics, or other immune therapies. They must have certain scores on disease activity and endoscopy scales. Kids with recent major bowel surgery or those needing it soon can't join.
What is being tested?
The study tests the effectiveness and safety of an oral medication called Ozanimod in young patients. It aims to see how the drug behaves in their bodies and its impact on Crohn's Disease symptoms.
What are the potential side effects?
Possible side effects of Ozanimod include headache, high blood pressure, liver enzyme changes, respiratory infections, flu-like symptoms, back pain and stomach-area (abdominal) pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 3 trial • 1320 Patients • NCT02047734
49%
Influenza Like Illness
12%
Headache
11%
Nasopharyngitis
8%
Upper Respiratory Tract Infection
6%
Orthostatic Hypotension
6%
Pyrexia
5%
Alanine Aminotransferase Increased
4%
Urinary Tract Infection
3%
Hypertension
3%
Pharyngitis
2%
Gamma-Glutamyltransferase Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Interferon Beta-1a
Ozanimod 0.5 mg
Ozanimod 1 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Ozanimod Dose Level 2Experimental Treatment1 Intervention
Group II: Ozanimod Dose Level 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ozanimod
2020
Completed Phase 3
~3510

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,427 Total Patients Enrolled

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05470985 — Phase 2 & 3
Crohn's Disease Research Study Groups: Ozanimod Dose Level 1, Ozanimod Dose Level 2
Crohn's Disease Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT05470985 — Phase 2 & 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05470985 — Phase 2 & 3
~71 spots leftby Sep 2026
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