A pivotal Phase III trial of Sanofi and Regeneron’s Dupixent (dupilumab) to treat severe atopic dermatitis in children aged six to 11 years has met its primary and secondary endpoints.
Dupixent, which is being developed by the companies under a global collaboration agreement, is a fully-human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.
The randomised, double-blind, placebo-controlled Dupixent paediatric trial has evaluated the efficacy and safety of the antibody combined with topical corticosteroids (TCS) in children with severe atopic dermatitis.
A total of 367 patients aged six to 11 years were enrolled for the trial and all of them received TCS throughout the trial.
They were randomised into one of three treatment groups for a period of 16 weeks.
Based on the topline data, it was found that adding Dupixent to standard-of-care TCS for children with severe atopic dermatitis significantly improved measures of overall disease severity, skin clearing, itching, and health-related quality of life, compared to TCS alone.
Regeneron president and chief scientific officer George Yancopoulos said: “The results from this trial, the first to assess a biologic medicine in children under 12 with atopic dermatitis, are very important because of the significant unmet needs in this patient population.
“Children in the trial had suffered from severe atopic dermatitis for most of their lives.”
Sanofi and Regeneron are also studying dupilumab in other clinical development programmes for diseases driven by allergic and other type 2 inflammation.
Sanofi Research and Development global head John Reed said: “In this trial, children with severe atopic dermatitis had uncontrolled disease covering, on average, nearly 60% of their skin.
“We are encouraged by these results, which demonstrate that Dupixent improved skin lesions, reduced itching, cleared the skin and, importantly, improved health-related quality of life measures for these young patients.”