Fenebrutinib for Relapsing Multiple Sclerosis
(FENhance Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it mentions that any previous treatment with immunomodulatory or immunosuppressive medication requires an appropriate washout period (time without taking certain medications). It's best to discuss your current medications with the study team.
Is Fenebrutinib safe for humans?
How is the drug Fenebrutinib different from other treatments for relapsing multiple sclerosis?
Research Team
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Eligibility Criteria
Adults with Relapsing Multiple Sclerosis (RMS) who meet specific criteria like an EDSS score of 0-5.5, can complete certain physical tests within set times, and agree to use contraception or abstain from sex. Excluded are those with disease duration over 10 years and low disability, pregnant or breastfeeding women, individuals with recent cancer history, active infections including hepatitis B/C and TB, significant blood disorders or immunodeficiency.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Double-Blind Treatment
Participants are randomized to receive either fenebrutinib or teriflunomide in a double-blind fashion
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension (optional)
Participants may opt into continuation of treatment long-term after the double-blind phase
Treatment Details
Interventions
- Fenebrutinib
- Placebo
- Teriflunomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University