Sanofi-Regeneron Dupixent meets main goal of reducing itch in phase 3 skin disease trial
ipopba/iStock via Getty Images


A second phase 3 trial of Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) medicine Dupixent (dupilumab) met its main and key secondary goals, showing the drug significantly reduced itch and skin lesions in patients with prurigo nodularis compared to placebo after 24 weeks of treatment.

Prurigo nodularis is a chronic inflammatory skin disease that causes extreme itch and skin lesions.
The phase 3 trial â dubbed PRIME, which is part of LIBERTY-PN PRIME clinical program â showed that 60% of Dupixent patients experienced a clinically meaningful reduction in itch from baseline, compared to 18% of placebo patients.
About 48% of Dupixent patients achieved clear or almost clear skin, a secondary endpoint, compared to 18% of placebo patients.
The companies said Dupixent patients experienced significantly greater improvements in overall health-related quality of life, skin pain, and symptoms of anxiety and depression.
Overall rates of treatment-emergent adverse events were 71% for Dupixent and 63% for placebo. Adverse events most commonly observed with Dupixent included nasopharyngitis and headache.
The companies noted that the safety results of the trial were consistent with what was seen in PRIME2 and were also generally consistent with the known safety profile of Dupixent in its approved indications.
The companies added that data confirm the positive results that were previously reported from the phase 3 PRIME2 trial and will be submitted to regulatory authorities around the world starting in the first half of this year.