Multiple Sclerosis Clinical Trial

Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Summary

The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.

Meets at least 1 of the following criteria for disease activity:

i) At least 1 MS relapse/attack in the previous year prior to screening.

ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.

iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).

- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.

Exclusion Criteria:

Diagnosis of progressive forms of MS.
Active or chronic disease of the immune system other than MS.
Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
Other protocol-defined Inclusion/Exclusion criteria apply.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

194

Study ID:

NCT06408259

Recruitment Status:

Not yet recruiting

Sponsor:

Celgene

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There are 5 Locations for this study

See Locations Near You

UCSF Benioff Children's Hospital San Francisco
San Francisco California, 94158, United States More Info
Emmanuelle Waubant, Site 0075
Contact
415-514-2468
Axiom Clinical Research of Florida
Tampa Florida, 33609, United States More Info
Mark Cascione, Site 0024
Contact
813-353-9613
University of South Florida
Tampa Florida, 33612, United States More Info
Derrick Robertson, Site 0053
Contact
813-974-6378
Washington University
Saint Louis Missouri, 63110, United States More Info
Soe Mar, Site 0025
Contact
314-732-0429
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Ahmed Obeidat, Site 0033
Contact
937-608-2712

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

194

Study ID:

NCT06408259

Recruitment Status:

Not yet recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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