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
Listed as NCT06141473, this observational or N/A phase trial focuses on Multiple Sclerosis and remains actively recruiting participants. Sponsored by Sanofi, it has been updated 29 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
29 versions recorded-
Apr 13, 2026 — Present [daily]
Recruiting
Phase: PHASE3 → None
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Mar 2026 — Present [monthly]
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▶ Show 24 earlier versions
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Jan 2026 — Present [monthly]
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Status: Not Yet Recruiting → Recruiting
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Dec 2023 — Jan 2024 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide in male and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will have variable duration depending on the recruitment rate, the event rate, the study discontinuation rate and the 12-month minimum treatment duration. Different participants will have different study durations. The last participant randomized will have at least 12 months of study duration, and assuming a 28-month recruitment period, the first participant randomized will have 40 months or longer of study duration. * The study intervention duration will vary similarly as the study duration. * The assessment of scheduled visits will include 1 common end of study \[EOS\] visit and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6 months and then every 3 months.
Contact Information
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .