French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and US-based biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) on Wednesday announced positive results from a phase 3 study of Dupixent (dupilumab) for patients with uncontrolled chronic spontaneous urticaria (CSU).

The study, LIBERTY-CUPID Study C, found that Dupixent significantly reduced itch and urticaria activity compared to placebo.

These results build on the findings of an earlier phase 3 study, CUPID-A, and support regulatory resubmission in the United States by the end of the year. If approved, Dupixent would be the first targeted therapy for CSU in a decade.

CSU is a chronic skin condition characterised by sudden, debilitating hives and persistent itch. It can significantly impact quality of life for affected patients.

The study enrolled 151 patients who were randomised to receive Dupixent or placebo in addition to standard-of-care antihistamines.

At 24 weeks, Dupixent-treated patients experienced a greater reduction in itch severity and urticaria activity compared to those receiving placebo. Additionally, a higher percentage of Dupixent-treated patients reported complete remission of their urticaria.

The safety profile of Dupixent in this study was generally consistent with its known safety profile in other approved indications.

Sanofi plans to submit detailed results from the study to the US Food and Drug Administration (FDA) in support of its supplemental biologics application for Dupixent in CSU.