Sanofi SA ((SNY)), Sanofi ((SNYNF)), Sanofi ((DE:SNW)) announced an update on their ongoing clinical study.
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Sanofi SA is currently conducting a clinical study titled ‘Efficacy and Safety of SAR441344 in the Treatment of Systemic Lupus Erythematosus.’ This Phase 2 study aims to evaluate the efficacy and safety of Frexalimab (SAR441344) in treating adults aged 18 to 70 with active Systemic Lupus Erythematosus (SLE). The study’s significance lies in its potential to offer a new treatment option for SLE, a chronic autoimmune disease.
The intervention being tested is Frexalimab, administered initially via intravenous infusion and subsequently through subcutaneous injections. The study compares this treatment against a placebo to assess its effectiveness over a 24-week period.
This randomized, double-blind study employs a parallel intervention model with quadruple masking, ensuring that participants, care providers, investigators, and outcomes assessors are unaware of the treatment allocations. The primary purpose is treatment-focused, aiming to establish proof of concept for Frexalimab’s efficacy in SLE.
The study began on November 10, 2021, with an estimated completion date in 2025. The last update was submitted on June 25, 2025. These dates are crucial as they indicate the study’s progress and timeline for potential results.
The outcome of this study could significantly impact Sanofi’s stock performance and investor sentiment, particularly if Frexalimab proves to be a successful treatment for SLE. This development could position Sanofi favorably against competitors in the autoimmune treatment market.
The study is ongoing, with further details available on the ClinicalTrials portal.