3상모집 중단 (진행 중)

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis

연구 개요

A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

스폰서
리드: 로슈
적응증
Multiple Sclerosis, Primary Progressive
중재
Fenebrutinib, Ocrelizumab, Placebo matched to ocrelizumab, Placebo matched to fenebrutinib
목표 등록
985
시작일
2020-10-26
완료(예정)
2027-07-21

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