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: 13 Mar 2026

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At a glance

Drugs Colestyramine (Primary) ; Frexalimab (Primary) ; Charcoal; Contrast media; Gadobutrol; Teriflunomide
Indications Multiple sclerosis
Focus Registrational; Therapeutic Use
Acronyms FREXALT; FREXALT-1
Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement

28 Aug 2025 Planned number of patients changed from 1400 to 1600.
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.

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