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Sphingosine 1-phosphate receptor modulator

Oral Ozanimod for Pediatric Ulcerative Colitis

Phase 2 & 3
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy
Must not have
Apheresis within 2 weeks of randomization
History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether the drug ozanimod is effective and safe in treating ulcerative colitis in children who haven't responded to other treatments.

Who is the study for?
This trial is for children with moderate to severe active ulcerative colitis who haven't responded well to conventional treatments like oral aminosalicylates, corticosteroids, immunomodulators, or biologics. They must have UC beyond the rectum confirmed by endoscopy. Kids with positive tests for C. difficile, recent apheresis, immune deficiencies, genetic disorders causing colitis, or diagnosed with Crohn's disease can't participate.
What is being tested?
The study is testing the effectiveness and safety of an oral medication called Ozanimod in pediatric patients. It aims to see if this drug can help achieve and maintain clinical remission in kids who have not had success with standard therapies for their ulcerative colitis.
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications like Ozanimod may include headache, high blood pressure, liver enzyme elevations which could indicate liver injury; respiratory infections; and potential increase in heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with moderate to severe Ulcerative Colitis before the screening.
Select...
My UC didn't improve with treatments like steroids or biologics.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have undergone apheresis within the last 2 weeks.
Select...
I have a history of immune system problems or genetic disorders causing colitis.
Select...
I have been diagnosed with Crohn's disease or indeterminate colitis.

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 Low DoseExperimental Treatment1 Intervention
Group II: Ozanimod High DoseExperimental 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
4,129,449 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
8,530 Patients Enrolled for Ulcerative Colitis

Media Library

Ozanimod (Sphingosine 1-phosphate receptor modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05076175 — Phase 2 & 3
Ulcerative Colitis Research Study Groups: Ozanimod High Dose, Ozanimod Low Dose
Ulcerative Colitis Clinical Trial 2023: Ozanimod Highlights & Side Effects. Trial Name: NCT05076175 — Phase 2 & 3
Ozanimod (Sphingosine 1-phosphate receptor modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076175 — Phase 2 & 3
~46 spots leftby May 2026
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