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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

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Trial Profile

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, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Dec 2025

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At a glance

  • Drugs Fenebrutinib (Primary) ; Teriflunomide
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FENhance 2
  • Sponsors Roche

Most Recent Events

  • 09 Nov 2025 According to a Genentech media release, all data together will be considered for submission to regulatory authorities.
  • 09 Nov 2025 According to a Genentech media release, following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.
  • 09 Nov 2025 Primary endpoint (Annualized Relapse Rate (ARR)) has been met, according to results presented in the Genentech Media Release.

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