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

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

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).

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.