5 trials tracked · 5 active · last refreshed 2026-08-10
Fenebrutinib is Roche's BTK inhibitor for multiple sclerosis, mechanistically similar to remibrutinib (both aim to reach immune activity inside the brain that antibody-based MS drugs can't). Its trials are the most direct head-to-head tests among the BTK candidates tracked here — separate Phase III trials compare it against teriflunomide in relapsing MS and, notably, against ocrelizumab itself (Roche's own already-approved MS antibody) in primary progressive MS, an unusually direct test of whether the newer drug can outperform the company's existing standard of care.
All 5 tracked trials are active, none yet completed with results — this is a program still waiting on its first Phase III readout.
Click a row for what it's testing, where, and how many participants.
| NCT ID | Title | Phase | Status | Started | |
|---|---|---|---|---|---|
| ▸ | NCT07161258 | A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS) | Phase II | Recruiting | 2025-10-06 |
This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \< 18 years. This study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period. Enrollment 12 (estimated) Sites 17 across 7 countries Countries Argentina, Brazil, Mexico, Poland, Portugal +2 more Sponsor Hoffmann-La Roche Primary outcome: Plasma Concentration of Fenebrutinib | |||||
| ▸ | NCT05119569 | A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS) | Phase II | Active, not recruiting | 2022-03-01 |
This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase. Enrollment 109 (actual) Sites 17 across 6 countries Countries Bosnia and Herzegovina, Croatia, Czechia, Serbia, Slovakia +1 more Sponsor Hoffmann-La Roche Primary outcome: DBT Phase: New Gadolinium (Gd) - Enhancing T1 Lesion Rate Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain Over 12 Weeks | |||||
| ▸ | NCT04586023 | Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) | Phase III | Active, not recruiting | 2021-03-24 |
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. Enrollment 751 (actual) Sites 106 across 17 countries Countries Austria, Brazil, Bulgaria, Canada, Denmark +12 more Sponsor Hoffmann-La Roche Primary outcome: Annualized Relapse Rate (ARR) | |||||
| ▸ | NCT04586010 | A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) | Phase III | Active, not recruiting | 2021-03-17 |
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. Enrollment 746 (actual) Sites 160 across 23 countries Countries Argentina, China, Dominican Republic, Finland, Georgia +18 more Sponsor Hoffmann-La Roche Primary outcome: Annualized Relapse Rate (ARR) | |||||
| ▸ | NCT04544449 | A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Ocrelizumab in Adult Participants With Primary Progressive Multiple Sclerosis | Phase III | Active, not recruiting | 2020-10-26 |
A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (and placebo) or intravenous (IV) ocrelizumab (and placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). 985 participants were enrolled and recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study. Enrollment 985 (actual) Sites 190 across 28 countries Countries Argentina, Australia, Austria, Brazil, Bulgaria +23 more Sponsor Hoffmann-La Roche Primary outcome: Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12) | |||||
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