Recruiting PHASE3 INTERVENTIONAL 2-arm NCT06141473

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis (FREXALT)

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

Sponsor: Sanofi

Conditions Multiple Sclerosis

Interventions Activated charcoal Cholestyramine Frexalimab MRI contrast-enhancing agents Placebo infusion Placebo tablet Teriflunomide

Updated 26 times since 2023 Last updated: Mar 4, 2026 Started: Dec 13, 2023 Primary completion: May 6, 2027 Completion: May 6, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT06141473, this PHASE3 trial focuses on Multiple Sclerosis and remains actively recruiting participants. Sponsored by Sanofi, it has been updated 26 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

26 versions recorded

Mar 2026 — Present [monthly]

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▶ Show 21 earlier versions

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Status: Not Yet Recruiting → Recruiting
Dec 2023 — Jan 2024 [monthly]

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First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Abington, United States , Abu Dhabi, United Arab Emirates , Albuquerque, United States , Alexandria, United States , Altamonte Springs, United States , Ankara, Turkey (Türkiye) , Asahikawa, Japan , Athens, Greece , Aurora, United States , Bangkok, Thailand and 300 more locations