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A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

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Trial Profile

A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Sep 2026

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At a glance

  • Drugs Frexalimab (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FREVIVA
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

Most Recent Events

  • 14 May 2026 Planned primary completion date changed from 23 Dec 2026 to 24 Mar 2028.
  • 14 May 2026 Status changed from recruiting to active, no longer recruiting.
  • 10 Feb 2025 Planned number of patients changed from 858 to 900.

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