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 (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be 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.
| Condition | Multiple Sclerosis, Primary Progressive |
|---|---|
| Treatment | Placebo, Ocrelizumab, Fenebrutinib |
| Clinical Study Identifier | NCT04544449 |
| Sponsor | Hoffmann-La Roche |
| Last Modified on | 15 September 2023 |
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