About this trial
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
This trial does not accept healthy volunteersQualifiers
Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Ozanimod
DrugSpecified dose on specified days
Fingolimod
DrugSpecified dose on specified days
Placebo
Other interventionSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Annualized relapse rate (ARR)
Secondary outcomes
Proportion of participants who did not have a confirmed relapse
Number of gadolinium enhancing (GdE) T1 lesions
Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences
Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period
Sponsors and contacts
Click on the lead sponsor to view all of their trials.