NCT04544449

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants 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.

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 985 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis, Primary Progressive

Interventions

Type	Name	Description
DRUG	Fenebrutinib	Participants will receive fenebrutinib.
DRUG	Ocrelizumab	Participants will receive ocrelizumab.
DRUG	Placebo matched to ocrelizumab	Participants will receive ocrelizumab-matching placebo.
DRUG	Placebo matched to fenebrutinib	Participants will receive fenebrutinib-matching placebo

Timeline

• Start date: 2020-10-26
• Primary completion: 2025-09-17
• Completion: 2027-07-21
• First posted: 2020-09-10
• Last updated: 2026-03-27

Locations

189 sites across 28 countries: United States, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, North Macedonia, Peru, Poland, Portugal, Puerto Rico, Russia, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study