NCT04586023

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fenebrutinib	Participants will receive fenebrutinib.
DRUG	Teriflunomide	Participants will receive teriflunomide.
DRUG	Placebo	Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.

Timeline

• Start date: 2021-03-24
• Primary completion: 2025-09-05
• Completion: 2027-07-09
• First posted: 2020-10-14
• Last updated: 2026-03-16

Locations

108 sites across 17 countries: United States, Austria, Brazil, Bulgaria, Canada, Denmark, France, Greece, Guatemala, India, Italy, Mexico, Poland, Russia, South Korea, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study