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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-17
SponsorBristol-Myers Squibb

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Ozanimod

    Drug

    Specified dose on specified days

  • Fingolimod

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

Treatment groups

194 Participants
are divided into 2 treatment groups
Group A: OzanimodExperimental treatment 2 interventions
Group B: FingolimodActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Annualized relapse rate (ARR)

Time frame
Up to 2 years

Secondary outcomes

1

Proportion of participants who did not have a confirmed relapse

Time frame
At 12 and 24 months
2

Number of gadolinium enhancing (GdE) T1 lesions

Time frame
At month 6 and month 12
3

Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences

Time frame
At 6, 12, 18, and 24 months
4

Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period

Time frame
Up to 87 months

Other outcomes

Sponsors and contacts

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