ORATORIO is a randomized, double-blind, global multi-center, Phase 3 study evaluating the efficacy and safety of ocrelizumab 600mg every six months compared with placebo in 732 patients with PPMS. The primary endpoint was time to onset of confirmed disability progression (CDP), defined as an increase in Expanded Disability Status Scale (EDSS) that is sustained for at least 12 weeks.
The study met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo, as measured by EDSS. Detailed results will be presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
In addition to ORATORIO, ocrelizumab is also being studied in other Phase 3 trials, OPERA I and OPERA II, for the treatment of relapsing forms of MS. Results of both studies will also be presented at ECTRIMS. Genentech plans to submit data from all three studies to the FDA in early 2016.
Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS.
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