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: 2026-01-09
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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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 - 0114
Loma Linda, California, United States
Local Institution - 0130
Sacramento, California, 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
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
Local Institution - 0081
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
Local Institution - 0134
Caguas, , Puerto Rico
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
Ondokuz Mayıs Universitesi
Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Site 0114
Role: primary
Site 0130
Role: primary
Natalie Moreo, Site 0053
Role: primary
Site 0055
Role: primary
Site 0047
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
Site 0081
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
Site 0134
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
murat terzi, 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
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