NCT04586010

A 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: 746 (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 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension 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: 2021-03-17
• Primary completion: 2026-01-27
• Completion: 2027-11-30
• First posted: 2020-10-14
• Last updated: 2026-02-17

Locations

160 sites across 23 countries: United States, Argentina, China, Dominican Republic, Finland, Georgia, Germany, Hong Kong, Hungary, Italy, Kenya, Mexico, Netherlands, North Macedonia, Peru, Poland, Portugal, Russia, Serbia, Spain, Switzerland, Tunisia, Ukraine

Regulatory

• FDA-regulated drug study