drugset / Trial / NCT04586023

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

NCT04586023

Phase 3 Active not recruiting 751 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-03-24
Primary completion
2025-09-05
Completion
2027-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenebrutinib Small molecule Oral
Comparator Teriflunomide Small molecule Oral

Indications