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 company said 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.
Dr Karl Ziegelbauer, Chief Scientific Officer at Almirall, said: “At Almirall, we are committed to advancing skin science through a holistic approach to disease management, recognising the profound effect skin conditions have on people’s lives. We are excited about the positive, top-line results from the phase 3 ADorable-1 trial and the meaningful impact they could have on children and adolescents and their life trajectories.”
Prof Weidinger, Department of Dermatology, Allergology and Venerology at University Hospital Schleswig-Holstein in Kiel, Germany, explained: “Children with atopic dermatitis still face considerable unmet needs, with persistent symptoms, limited treatment options, and a disease burden that grows with severity. There is a need for advanced treatment solutions, considering the specific challenges of younger patients and their families.”
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.
