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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05123703
Study type Interventional
Source Hoffmann-La Roche
Contact Reference Study ID Number: WN42086 https://forpatients.roche.com
Phone 888-662-6728 (U.S. and Canada)
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date January 31, 2022
Completion date November 5, 2029

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