RecruitingPhase 3NCT06408259
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
Sponsor
Celgene
Enrollment
194 participants
Start Date
Apr 8, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 10 YearsMax Age: 17 Years
Inclusion Criteria6
- 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 Criteria3
- 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.
Interventions
DRUGOzanimod
Specified dose on specified days
DRUGFingolimod
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Locations(33)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06408259
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