Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance 2)
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) (FENhance 2)
ClinicalTrials.gov ID: NCT04586023
Sponsor: Hoffmann-La Roche
Information provided by: Hoffmann-La Roche (Responsible Party)
Last Update Posted: 2023-08-22
Brief 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. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.
OFFICIAL TITLE
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
INTERVENTION / TREATMENT
Drug: Fenebrutinib
Drug: Teriflunomide
Drug: Placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2021-03-24 |
| Primary Completion (Estimated) | 2025-10-02 |
| Study Completion (Estimated) | 2025-11-27 |
| Enrollment (Estimated) | 736 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers | GN42272 2020-001168-28 (EudraCT Number) 2022-502618-95-00 (Registry Identifier) (REGISTRY: EU Trial Number) |