Randomized, double-blind study comparing frexalimab (SAR441344) to teriflunomide in adult with relapsing multiple sclerosis
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
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Clinical Trial Information
Trial Contact: Monserrate, Francheska; Carlo, Charlene S; Mondragon, Diana; Melendez, Thomas L; Flores-Vega, Mariangelis
Trial Phone: 321-841-4717 ; 321.841.1324 ; 3218419454 ; 321.841.6813 ; 321-841-717
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IRB No: W23.203.10
Protocol Abbrev: EFC17919
Principal Investigator: Amy (Amparo) Gutierrez, MD, FAAN
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: EFC17919
Treatment: frexalimab (SAR441344) and teriflunomide
ClinicalTrials.gov ID: NCT06141473
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Objective
Primary
• To assess the efficacy of frexalimab compared to
a daily dose of 14 mg teriflunomide measured by
ARR in participants with relapsing forms of MS
Secondary
• To assess the efficacy of frexalimab compared to
teriflunomide on disability worsening, MRI lesions,
cognitive performance, physical function, and
quality of life -
Key Eligibility
Patients 18 to 55 years of age diagnosed with RMS
