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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 3 trial • 1320 Patients • NCT0204773449%
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
2,686 Previous Clinical Trials
4,129,707 Total Patients Enrolled
14 Trials studying Ulcerative Colitis
8,530 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone apheresis within the last 2 weeks.I have been diagnosed with moderate to severe Ulcerative Colitis before the screening.I have a history of immune system problems or genetic disorders causing colitis.I have been diagnosed with Crohn's disease or indeterminate colitis.My UC didn't improve with treatments like steroids or biologics.
Research Study Groups:
This trial has the following groups:- Group 1: Ozanimod High Dose
- Group 2: Ozanimod Low Dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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