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
- 985명
- 시작일
- 2020-10-26
- 완료(예정)
- 2027-07-21
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