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

NCT06408259 · Celgene
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Official title
A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis
About this study
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).
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 design
Enrollment target: 194 participants
Allocation: randomized
Masking: quadruple
Age groups: child
Timeline
Starts: 2025-04-08
Estimated completion: 2036-07-13
Last updated: 2026-02-05
Interventions
Drug: OzanimodDrug: FingolimodOther: Placebo
Primary outcomes
  • Annualized relapse rate (ARR) (Up to 2 years)
Sponsor
Celgene · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (33)
Local Institution - 0114Not Yet Recruiting
Loma Linda, California, United States
University of California Davis HealthRecruiting
Sacramento, California, United States
University of South FloridaRecruiting
Tampa, Florida, United States
Local Institution - 0093Withdrawn
Chicago, Illinois, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
Local Institution - 0047Not Yet Recruiting
Louisville, Kentucky, United States
Local Institution - 0131Not Yet Recruiting
New Brunswick, New Jersey, United States
Local Institution - 0132Withdrawn
Teaneck, New Jersey, United States
Local Institution - 0091Withdrawn
Cincinnati, Ohio, United States
Local Institution - 0092Not Yet Recruiting
Portland, Oregon, United States
Local Institution - 0133Not Yet Recruiting
El Paso, Texas, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Royal Children's HospitalRecruiting
Melbourne, Victoria, Australia
University of Naples Federico IIRecruiting
Naples, Campania, Italy
Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Local Institution - 0081Not Yet Recruiting
Milan, Lombardy, Italy
Neurological Center Of LatiumRecruiting
Rome, Roma, Italy
Local Institution - 0078Withdrawn
Mexico City, DIF, Mexico
Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
Poznan, Greater Poland Voivodeship, Poland
2Ca BragaRecruiting
Braga, Portugal
Unidade Local de Saúde de Coimbra, E.P.E.Recruiting
Coimbra, Portugal
Centro Hospitalar de Lisboa CentralRecruiting
Lisbon, Portugal
Local Institution - 0102Withdrawn
Porto, Portugal
Local Institution - 0134Not Yet Recruiting
Caguas, Puerto Rico
Spitalul Clinic de Copii Doctor Victor GomoiuRecruiting
Bucharest, Bucharest, Romania
Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting
Bucharest, Bucharest, Romania
Local Institution - 0096Not Yet Recruiting
Esplugues de Llobregat, Barcelona [Barcelona], Spain
CHUVI- Hospital Alvaro CunqueiroRecruiting
Vigo, Pontevedra [Pontevedra], Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain
Hospital Universitario Miguel ServetRecruiting
Zaragoza, Spain
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Ondokuz Mayıs UniversitesiRecruiting
Samsun, Turkey (Türkiye)
Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis · TrialPath