Study Detail
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Sanofi Study for Relapsing Multiple Sclerosis
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis
Sanofi’s FREXALT Study is looking for people with relapsing forms of multiple sclerosis (RMS) to take part. The purpose of the study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of teriflunomide.
Additional Study Details
This event-driven study will have variable duration of approximately 40 months for the first participant being randomized and approximately 20 months for the last participant randomized.
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.
Participants will receive a stipend for each visit as well as travel reimbursement
Who can take part in the study?
Individuals 18-55 years old
Individuals with a previous diagnosis of RRMS
Individuals with an EDSS score ≤5.5 at the first visit (screening visit)
Individuals with at least 1 of the following prior to screening:
≥1 documented relapse within the previous year OR
≥2 documented relapses within the previous 2 years, OR
≥1 documented Gd enhancing lesion on an MRI scan within the previous year.
