Lebrikizumab and Stapokibart Show Efficacy in Pediatric Atopic Dermatitis Trials
Two phase 3 trials demonstrate significant improvements in skin clearance and disease severity for children and adolescents with moderate-to-severe atopic dermatitis treated with targeted biologics.
Almirall has reported positive top-line results from its phase 3 ADorable-1 trial, which evaluated lebrikizumab in children and adolescents aged six months to under 18 years with moderate-to-severe atopic dermatitis. The treatment met both co-primary and key secondary endpoints, with results showing notable improvements in skin clearance, disease severity, itch and quality of life at week 16.
According to the data, 63% of paediatric patients achieved meaningful skin improvement and 44% reached clear or almost clear skin. The trial enrolled 363 inadequately controlled patients who received weight-based doses of lebrikizumab or placebo every two or four weeks, alongside topical corticosteroids. Key findings included significant reductions in disease severity, near-complete skin clearance and improved quality of life, with benefits seen across symptoms, emotional impact, sleep and daily activities.
Safety results were consistent with the established profile of lebrikizumab, with no new safety signals observed. The most common adverse events were upper respiratory tract infections and nasopharyngitis. Further results from ADorable-1 and the 52-week ADorable-2 extension study are expected later this year, alongside ongoing research into additional dermatological indications.
In a separate randomized, double-blind, placebo-controlled phase 3 trial, stapokibart demonstrated high efficacy in adolescents with moderate-to-severe atopic dermatitis. Stapokibart is a novel humanized monoclonal antibody targeting IL-4Rα that has been approved for the treatment of adults with moderate-to-severe AD in China.
Of the 180 enrolled patients, 120 received stapokibart and 60 received placebo. Patients with a baseline weight ≥60 kg received subcutaneous stapokibart or placebo every two weeks, while those weighting 30 to <60 kg received treatment every three weeks. All patients were given moisturizers during the whole study. Totally 178 (98.9%) patients completed the double-blind treatment.
At week 18, higher proportions of stapokibart- vs. placebo-treated patients achieved EASI-75 (73.9% vs. 43.3%; difference: 30.5%; P<0.0001) and an IGA response (57.1% vs. 25.0%; difference: 31.8%; P<0.0001). The proportion of patients achieving ≥4-point reductions in weekly average of daily Peak Pruritus Numerical Rating Scale score was also significantly higher in stapokibart group than in placebo group (36.1% vs. 15.0%; difference: 21.1%; P=0.0037).
The incidence of adverse events was similar between the stapokibart (62.5%) and placebo (61.7%) groups. No conjunctivitis was found.