BENITIONSClinical Trial Intelligence

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

Phase 3 Active, not recruiting NCT04548999

ConditionMultiple Sclerosis
PhasePhase 3
SponsorHoffmann-La Roche
StatusActive, not recruiting
Enrollment769 participants
InterventionsOcrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone
Start dateDec 3, 2020
Completion dateJun 30, 2025
Results postedJul 24, 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 PPMS, 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 4.5 years · weeks

Ocrelizumab 600 mg158.7 weeks
Ocrelizumab 1200 mg or 1800 mg169.0 weeks
p-value0.6376
Hazard Ratio (HR)0.95 (95% CI 0.76–1.18)

Open in BENITIONS View on ClinicalTrials.gov

Other trials for this condition

All trials

This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.