BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT05123703

ConditionRelapsing-remitting Multiple Sclerosis
PhasePhase 3
SponsorHoffmann-La Roche
StatusActive, not recruiting
Enrollment188 participants
InterventionsOcrelizumab, Ocrelizumab Placebo, Fingolimod, Fingolimod Placebo
Start dateMay 19, 2022
Completion dateJun 9, 2025
Results postedJul 15, 2026

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-defined Annualized Relapse Rate (ARR)

Up to after the last participant randomized completed 24 weeks since first study treatment administration (up to approximately 160 weeks) · relapses per patient-year

Ocrelizumab0.070 relapses per patient-year
Fingolimod0.135 relapses per patient-year
Adjusted Rate Ratio0.517 (95% CI 0.193–1.329)

Open in BENITIONS View on ClinicalTrials.gov

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