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
| Condition | Multiple Sclerosis |
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| Phase | Phase 3 |
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| Sponsor | Hoffmann-La Roche |
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| Status | Active, not recruiting |
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| Enrollment | 769 participants |
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| Interventions | Ocrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone |
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| Start date | Dec 3, 2020 |
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| Completion date | Jun 30, 2025 |
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| Results posted | Jul 24, 2026 |
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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 mg | 158.7 weeks |
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| Ocrelizumab 1200 mg or 1800 mg | 169.0 weeks |
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| p-value | 0.6376 |
| Hazard Ratio (HR) | 0.95 (95% CI 0.76–1.18) |
Open in BENITIONS
View on ClinicalTrials.gov
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