A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Summary

This study will evaluate the efficacy and safety of ocrelizumab (Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).

Timeline

Start

2019-08-12

Primary completion

2025-01-15

Completion

2028-01-19

Outcome

Met primary endpoint

registry Ocrelizumab vs Placebo; p = 0.0007; Hazard Ratio (HR) 0.70 (95% CI 0.57 to 0.86); Log Rank NCT04035005 ↗

registry Ocrelizumab vs Placebo; p <.0001; Hazard Ratio (HR) 0.45 (95% CI 0.31 to 0.64); Log Rank NCT04035005 ↗

Publications

• Giovannoni G, Airas L, Bove R, Cutter GR, Czarnecki M, Drulovic J, Hobart J, Kuhle J, Montalban X, Selmaj KW, Tur C, Wolinsky JS, Baldinotti A, Bonati U, Craveiro L, Giacobino C, Manfrini M, Schneble HM, Stevenson P, Wang Q, Yang K, Oh J; ORATORIO-HAND study group. Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study. Lancet. 2026 May 30;407(10544):2195-2207. doi: 10.1016/S0140-6736(26)00617-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ocrelizumab	Monoclonal antibody	600 mg	Intravenous

Indications