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
The MS Center at EvergreenHealth is conducting a Phase III, randomized, double-blind, double-dummy,
parallel-group study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult patients with primary progressive multiple sclerosis (PPMS).
In this study, patients will receive fenebrutinib (or placebo) and ocrelizumab (or placebo).
Who may be eligible to participate?
Patients 18 to 65 years of age with PPMS may be eligible to participate. Other inclusion and exclusion criteria apply.
What does participation involve?
This study will consist of the following phases:
- screening (for up to four weeks)
- double-blind treatment (DBT) phase
- DBT safety follow-up (DBT-SFU)
- optional open-label extension (OLE)
- OLE safety follow-up (OLE-SFU) phase
All eligible patients will be randomized 1:1 to either daily fenebrutinib (or placebo) or ocrelizumab (or placebo).
Investigator
Theodore Brown, MD, MPH, EvergreenHealth MS Center
