Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi SA is conducting a clinical study titled ‘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.’ The study aims to evaluate the annualized relapse rate in patients with relapsing forms of multiple sclerosis, comparing the effects of Frexalimab to Teriflunomide. This research is significant as it may offer new insights into treatment options for this condition.
The intervention being tested includes Frexalimab, an experimental drug administered via infusion, and Teriflunomide, an active comparator given as an oral tablet. The study also involves placebo treatments and other supportive medications like MRI contrast agents, Cholestyramine, and Activated Charcoal.
The study design is interventional, with a randomized allocation and a parallel intervention model. It employs a quadruple masking approach, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment assignments. The primary purpose of the study is treatment-focused.
The study began on December 13, 2023, with an estimated completion timeline of approximately 40 months for the first participant and 20 months for the last. The most recent update was submitted on July 22, 2025, indicating ongoing recruitment and progress.
The market implications of this study are substantial, as positive results could enhance Sanofi’s market position and influence investor sentiment favorably. The development of Frexalimab could potentially impact the competitive landscape in the treatment of multiple sclerosis, offering a new alternative to existing therapies.
The study is currently ongoing, with further details available on the ClinicalTrials portal.