Sanofi SA ((SNY)), Sanofi ((DE:SNW)), Sanofi ((SNYNF)) announced an update on their ongoing clinical study.
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Sanofi recently completed a Phase 3 clinical study titled Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton’s Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2). The study aimed to evaluate the efficacy and safety of SAR442168 compared to Teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis (MS). The primary objective was to assess the annualized relapse rate, while secondary objectives included evaluating disability progression, MRI lesions, cognitive performance, and quality of life.
The study tested the drug Tolebrutinib, an oral BTK inhibitor, against Teriflunomide, an existing MS treatment. Tolebrutinib is intended to reduce relapse rates and improve overall patient outcomes in MS.
This randomized, double-blind study used a parallel intervention model with triple masking (participant, investigator, outcomes assessor) to ensure unbiased results. The primary purpose was treatment-focused.
The study began on June 11, 2020, and reached primary completion in June 2025, with the last update submitted on June 30, 2025. These dates are crucial as they mark the timeline of data collection and analysis, impacting the study’s relevance and timeliness.
The completion of this study could potentially boost Sanofi’s stock performance by demonstrating the efficacy of Tolebrutinib, positioning it as a strong competitor in the MS treatment market. Positive results might enhance investor sentiment and place Sanofi ahead of competitors in the MS drug market.
The study is completed, and further details are available on the ClinicalTrials portal.