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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

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Multiple Sclerosis, Relapsing-Remitting

Interventions: Ozanimod, Fingolimod, Placebo

Countries: United States, Australia, Italy, Mexico, Poland, Portugal, Puerto Rico, Romania

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 overview

Sex: ALL

Age: 10 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (33)

Loma Linda, California, United States
Sacramento, California, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Louisville, Kentucky, United States
New Brunswick, New Jersey, United States
Teaneck, New Jersey, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
El Paso, Texas, United States
Milwaukee, Wisconsin, United States
Melbourne, Victoria, Australia
Naples, Campania, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Rome, Roma, Italy
Mexico City, DIF, Mexico
Poznan, Greater Poland Voivodeship, Poland
Braga, Portugal
Coimbra, Portugal
Lisbon, Portugal
Porto, Portugal
Caguas, Puerto Rico
Bucharest, Bucharest, Romania
Bucharest, Bucharest, Romania
Esplugues de Llobregat, Barcelona [Barcelona], Spain
Vigo, Pontevedra [Pontevedra], Spain
Seville, Spain
Valencia, Spain
+ 3 more on CT.gov