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Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Trial Profile

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2025

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At a glance

  • Drugs Colestyramine (Primary) ; Frexalimab (Primary) ; Charcoal; Contrast media; Teriflunomide
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms FREXALT; FREXALT-1
  • Sponsors Sanofi
  • Most Recent Events

    • 25 Apr 2024 According to a Sanofi media release, regulatory submission expected in 2027.
    • 01 Feb 2024 According to a Sanofi media release, first participant has been treated.
    • 07 Dec 2023 Status changed from not yet recruiting to recruiting.

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