Overview
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.
Description
This Phase III randomized, double-blind, double-dummy, multicenter study will evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally daily, in children and adolescents with Multiple Sclerosis aged between 10 and < 18 years. The study plans to enroll 233 patients in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which patients will be treated with either active ocrelizumab or active fingolimod for at least 96 weeks. Patients who complete the double-blind period will be offered the possibility to enter an optional open-label extension treatment period of at least 144 weeks with ocrelizumab.
Eligibility
Inclusion Criteria:
- Body weight ≥ 40 kg
- Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017
- EDSS at screening: 0-5.5, inclusive
- Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1
- At least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months
Exclusion Criteria:
- Known presence or suspicion of other neurologic disorders that may mimic MS
- Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude patient from participating in the study
- Patient with severe cardiac disease or significant findings on the screening ECG