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

Celgene

Status and phase

Enrolling

Phase 3

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: Ozanimod

Drug: Fingolimod

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06408259

U1111-1281-5433 (Registry Identifier)

2022-501332-42 (Registry Identifier)

IM047-050

Details and patient eligibility

About

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).

Enrollment

194 estimated patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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.