BENITIONSClinical Trial Intelligence

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Phase 3 Active, not recruiting NCT04544436

ConditionMultiple Sclerosis
PhasePhase 3
SponsorHoffmann-La Roche
StatusActive, not recruiting
Enrollment864 participants
InterventionsOcrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone
Start dateNov 26, 2020
Completion dateDec 19, 2024
Results postedFeb 17, 2026

Summary

This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.

Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12)

Up to approximately 4 years · weeks

Ocrelizumab 600 mgNA weeks
Ocrelizumab 1200 mg or 1800 mgNA weeks
p-value0.5278
Hazard Ratio (HR)0.93 (95% CI 0.73–1.18)

Open in BENITIONS View on ClinicalTrials.gov

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