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Sphingosine-1-phosphate receptor modulator

Ozanimod vs Fingolimod for Multiple Sclerosis

Phase 3
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive
Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease
Must not have
Active or chronic disease of the immune system other than MS
Diagnosis of progressive forms of MS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

"This trial will compare the effectiveness, safety, and side effects of two drugs, ozanimod and fingolimod, in children and adolescents with relapsing remitting multiple sclerosis."

Who is the study for?
This trial is for children and adolescents with Relapsing Remitting Multiple Sclerosis (RRMS). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of RRMS.
What is being tested?
The study compares the effectiveness and safety of two drugs: Ozanimod and Fingolimod. Participants will receive either one of these drugs or a placebo to assess how well they work in treating RRMS in young patients.
What are the potential side effects?
While specific side effects are not listed, both Ozanimod and Fingolimod can potentially cause immune system effects, heart rate changes, liver issues, breathing problems, high blood pressure, swelling behind the eye (macular edema), skin cancer risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My disability level allows me to walk without aid or rest for 200 meters.
Select...
I have been diagnosed with relapsing-remitting multiple sclerosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an immune system condition that is not MS.
Select...
My MS is getting worse over time.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OzanimodExperimental Treatment2 Interventions
Group II: FingolimodActive Control2 Interventions
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?

CelgeneLead Sponsor
645 Previous Clinical Trials
130,246 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
6,963 Patients Enrolled for Multiple Sclerosis
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,569 Previous Clinical Trials
3,384,178 Total Patients Enrolled
12 Trials studying Multiple Sclerosis
16,972 Patients Enrolled for Multiple Sclerosis
~129 spots leftby Apr 2031
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