Sanofi and Regeneron’s Dupixent (dupilumab) has demonstrated significant improvements in itch and hives for patients with chronic spontaneous urticaria (CSU), according to late-stage results shared by the companies.
Detailed results from the confirmatory trial will be submitted to the US Food and Drug Administration (FDA) by the end of the year, after the regulator requested additional data for the therapy in this indication.
Study C of the phase 3 LIBERTY-CUPID programme randomised more than 150 CSU patients aged six years and older to receive Dupixent or placebo as an add-on to standard-of-care antihistamines.
Patients enrolled to the trial remained symptomatic despite antihistamine use and were not previously treated with Novartis and Genentech’s Xolair (omalizumab).
An 8.64-point reduction in itch severity from baseline was observed in the Dupixent group versus a 6.10-point reduction for placebo at 24 weeks.
Dupixent was also shown to be superior in reducing urticaria activity (itch and hive) severity, with a 15.86-point reduction from baseline compared to an 11.21-point reduction with placebo at 24 weeks.
The companies added that 30% of Dupixent-treated patients reported no urticaria (complete response) compared to 18% of those on placebo, and safety results were “generally consistent” with the known safety profile of Dupixent in its approved dermatological indications.
Affecting approximately 40 million people globally, CSU is an inflammatory skin disease characterised by red, raised, itchy and sometimes painful hives or wheals that last for six weeks or longer. The condition is usually treated with H1 antihistamines, but remains uncontrolled in many patients.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple diseases, including CSU.
Dietmar Berger, chief medical officer, global head of development at Sanofi, said: “The positive pivotal data from this study reinforces the potential of Dupixent to offer a new treatment option for the many people suffering from CSU who do not respond to standard-of-care antihistamines.
“With clinically meaningful reductions in itch and hives for patients receiving Dupixent, we look forward to sharing this data with the FDA to bring Dupixent to patients with CSU in the US as soon as possible.”