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

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.

Timeline

Start

2020-11-26

Primary completion

2024-12-19

Completion

2028-08-31

Publications

• Hauser SL, Giovannoni G, Montalban X, Oh J, Bar-Or A, Sormani MP, Weber MS, Stoll S, Nicholas JA, Nehrych T, Bonek R, Selmaj K, Maciejowski M, Zecevic D, Raposo C, Owen R, Bonati U, Madjar K, Harfst E, Wang Q, Raievska A, Manfrini M, Schneble HM, Kappos L; MUSETTE and GAVOTTE Study Groups. Efficacy and safety of a bodyweight-adjusted higher dose of ocrelizumab in relapsing (MUSETTE) and primary progressive (GAVOTTE) multiple sclerosis: two multicentre, randomised, double-blind, parallel-group phase 3b trials. Lancet. 2026 May 30;407(10544):2180-2194. doi: 10.1016/S0140-6736(26)00147-9.

Drugs

Indications