Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
NCT ID: NCT06408259
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
194 participants
INTERVENTIONAL
2025-04-08
2036-07-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ozanimod
Ozanimod
Specified dose on specified days
Placebo
Specified dose on specified days
Fingolimod
Fingolimod
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Ozanimod
Specified dose on specified days
Fingolimod
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* Active or chronic disease of the immune system other than MS.
* Clinically relevant cardiovascular, hepatic, neurological other major systematic disease.
10 Years
17 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0110
Phoenix, Arizona, United States
Local Institution - 0114
Loma Linda, California, United States
Local Institution - 0130
Sacramento, California, United States
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Local Institution - 0093
Chicago, Illinois, United States
Local Institution - 0055
Chicago, Illinois, United States
Local Institution - 0047
Louisville, Kentucky, United States
Washington University
St Louis, Missouri, United States
Local Institution - 0131
New Brunswick, New Jersey, United States
Local Institution - 0132
Teaneck, New Jersey, United States
Local Institution - 0091
Cincinnati, Ohio, United States
Local Institution - 0092
Portland, Oregon, United States
Local Institution - 0133
El Paso, Texas, United States
Local Institution - 0033
Milwaukee, Wisconsin, United States
Royal Children's Hospital
Melbourne, Victoria, Australia
University of Naples Federico II
Napoli, Campania, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Neurological Center Of Latium
Rome, Roma, Italy
Local Institution - 0078
Mexico City, DIF, Mexico
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Greater Poland Voivodeship, Poland
2Ca Braga
Braga, , Portugal
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, , Portugal
Centro Hospitalar de Lisboa Central
Lisbon, , Portugal
Local Institution - 0102
Porto, , Portugal
Spitalul Clinic de Copii Doctor Victor Gomoiu
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Local Institution - 0096
Esplugues de Llobregat, Barcelona [Barcelona], Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [Pontevedra], Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Local Institution - 0109
Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Site 0110
Role: primary
Site 0114
Role: primary
Site 0130
Role: primary
Emmanuelle Waubant, Site 0075
Role: primary
Mark Cascione, Site 0024
Role: primary
Natalie Moreo, Site 0053
Role: primary
Site 0055
Role: primary
Site 0047
Role: primary
Soe Mar, Site 0025
Role: primary
Site 0131
Role: primary
Site 0092
Role: primary
Site 0133
Role: primary
Site 0033
Role: primary
Eppie Yiu, Site 0113
Role: primary
Vincenzo Brescia Morra, Site 0083
Role: primary
Massimo Filippi, Site 0082
Role: primary
Carlo Pozzilli, Site 0086
Role: primary
Barbara Steinborn, Site 0108
Role: primary
Joao Cerqueira, Site 0103
Role: primary
Filipe Palavra, Site 0105
Role: primary
João Sequeira, Site 0104
Role: primary
Raluca Teleanu, Site 0088
Role: primary
Cristina Pomeran, Site 0087
Role: primary
Site 0096
Role: primary
Elena Rodriguez, Site 0098
Role: primary
SARA EICHAU MADUEÑO, Site 0099
Role: primary
Francisco Pérez-Miralles, Site 0094
Role: primary
Jesus Martin Martinez, Site 0101
Role: primary
Wang-Tso Lee, Site 0115
Role: primary
Site 0109
Role: primary
Related Links
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BMS Clinical Trial Information
Other Identifiers
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2022-501332-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1281-5433
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM047-050
Identifier Type: -
Identifier Source: org_study_id