Sanofi and Regeneron Pharmaceuticals have reported positive results from the Phase III clinical trial of Dupixent (dupilumab) in children aged six to 11 years with severe atopic dermatitis.
In combination with standard-of-care topical corticosteroids (TCS), the drug led to significant improvements in disease signs, symptoms, and health-related quality of life.
Dupixent is a fully-human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) protein signalling.
According to findings from clinical trials of the drug, IL-4 and IL-13 are involved in the type 2 inflammation associated with atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP).
The randomised, double-blind, placebo-controlled Phase III trial assessed the safety and efficacy of the drug plus TCS in 367 paediatric patients with atopic dermatitis covering an average of 60% of their skin.
In the trial, the majority of participants treated with the Dupixent combination experienced clear or almost clear skin at week 16 and more than two-thirds had a minimum of 75% overall improvement.
Trial principal investigator Amy Paller said: “In my practice, I see children with severe atopic dermatitis struggling with intense, persistent itching and skin lesions covering much of their body, and caregivers who are desperate for additional treatment options that can help control this disease.
“Data from the Phase III trial in children aged six to 11 adds to the established efficacy and safety data in adults and adolescents and provides hope to physicians and families for a potential new treatment option for children with this chronic disease.”
The companies reported positive top-line data from the trial in August last year.
The trial results are currently under review by regulatory agencies, including in the US, Canada and EU.