Safety and efficacy of stapokibart, an anti-interleukin-4 receptor α monoclonal antibody, in children aged 6–11 years with moderate-to-severe atopic dermatitis: an open-label single-arm phase Ib/IIa trial

BACKGROUND: Stapokibart is a novel anti-interleukin-4 receptor α (IL-4Rα) monoclonal antibody approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD). OBJECTIVES: To assess the safety, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of stapokibart in children with moderate-to-severe AD. METHODS: This was a multicentre open-label single-arm phase Ib/IIa trial (NCT06162507) involving 8 weeks of treatment and 8 weeks of follow-up. Children aged 6-11 years received subcutaneous stapokibart based on a bodyweight-tiered regimen (30-60 kg: 300 mg every 3 weeks for a total of three doses, including a 600-mg loading dose; 15-30 kg: 150 mg every 2 weeks for a total of four doses, including a 300-mg loading dose). RESULTS: Twenty-five patients (13 weighing 30-60 kg; 12 weighing 15-30 kg) received stapokibart; 68% reported mild or moderate adverse events. At week 8, 54% (n = 7/13) of those weighing 30-60 kg and 75% (n = 9/12) of those weighing 15-30 kg achieved a ≥ 75% improvement from baseline in Eczema Area and Severity Index. Stapokibart concentrations increased rapidly following the first dose, climbed further with repeated dosing and gradually declined after treatment discontinuation. Stapokibart reduced inflammatory biomarkers in both groups. No treatment-related antidrug antibodies were detected. No new safety signals emerged. CONCLUSIONS: Stapokibart shows potential in improving disease outcomes and appears to be well tolerated in children aged 6-11 years with moderate-to-severe AD. Larger controlled studies are needed to confirm long-term benefits.