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
Bristol-Myers Squibb
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
- Age range
- 10–17 years
- Sex
- All
- Healthy volunteers
- No
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 (EDS…
Interventions
- DrugOzanimod
Specified dose on specified days
- DrugFingolimod
Specified dose on specified days
- OtherPlacebo
Specified dose on specified days
Locations (33)
- Local Institution - 0114Loma Linda, California
- University of California Davis HealthSacramento, California
- University of South FloridaTampa, Florida
- Local Institution - 0093Chicago, Illinois
- University of Chicago Medical CenterChicago, Illinois
- University of Louisville, Norton Children's Research InstituteLouisville, Kentucky