A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Patients With Primary Progressive Multiple Sclerosis.
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.
Inclusion Criteria:
OLE Inclusion Criteria:
Exclusion Criteria:
OLE Exclusion Criteria:
Capital Federal, 000C1021, Argentina
Sofia, 1113, Bulgaria
Dresden, 01307, Germany
Freiburg im Breisgau, 79106, Germany
Rome, Lazio 00133, Italy
Tialnepantla, Mexico 54055, Mexico
Wroc?aw, 51-685, Poland
Krasnoyarsk, Krasnoyarsk Krai 660037, Russia
Moskva, Moscow Oblast 117997, Russia
Moskva, Moscow Oblast 127015, Russia
Chernivtsi, Chernihiv Governorate 58022, Ukraine
Zaporizhzhya, Kharkiv Governorate 69600, Ukraine
Dnipro, Tavria Okruha, Ukraine