Clinical Trial

A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)

Study acronym: Operetta 2
Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and \< 18 years over a flexible duration. The double-blind period will last until after the last participant randomized has completed 24 weeks.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-07-16
notable Trial sites reduced: 102 -> 71 locations 2026-07-16
Trial Details
NCT Number NCT05123703
Lead Sponsor Hoffmann-La Roche
Collaborators: PPD Development, LP
Conditions Relapsing-remitting Multiple Sclerosis
Enrollment 188 participants
Start Date 2022-05-19
Primary Completion 2025-06-09 (estimated)
Study Completion 2029-09-17 (estimated)
Updated on ClinicalTrials.gov 2026-07-15