Study Comparing Remibrutinib and Ocrelizumab Treatments for Adults Aged 40 to 70 with Relapsing Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the effects of remibrutinib compared to continuous ocrelizumab treatment in people living with relapsing multiple sclerosis RMS. This Phase 3b study aims to provide data on the efficacy, safety, and tolerability of remibrutinib when patients switch from ocrelizumab. The trial is randomized, open-label, and conducted across multiple centers globally, including the USA. Participants in the study are assigned to either switch to remibrutinib tablets taken orally or continue with ocrelizumab administered via infusion or injection at standard doses. The study includes a Core Part lasting up to 24 months, during which these treatments are compared. Those completing the Core Part may enter an Extension Part lasting up to 24 months, where all participants receive remibrutinib in an open-label format. Throughout the study, participants will undergo regular monitoring including MRI scans to measure new or enlarging T2 lesions and assessments for disease activity and adverse events. The main outcome is the annualized rate of new or enlarging T2 lesions during the Core Part, with continued evaluations during the Extension Part. Safety and tolerability are closely monitored, and total participation can last up to 48 months.

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.