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
| 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 | 864 participants |
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| Interventions | Ocrelizumab, Ocrelizumab, Antihistamine, Methylprednisolone |
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| Start date | Nov 26, 2020 |
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| Completion date | Dec 19, 2024 |
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| Results posted | Feb 17, 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 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 mg | NA weeks |
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| Ocrelizumab 1200 mg or 1800 mg | NA weeks |
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| p-value | 0.5278 |
| Hazard Ratio (HR) | 0.93 (95% CI 0.73–1.18) |
Open in BENITIONS
View on ClinicalTrials.gov
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