A PROMISING early-phase clinical trial has found that stapokibart, a monoclonal antibody targeting the IL-4 receptor alpha subunit, may offer a safe and effective treatment option for children aged 6–11 years with moderate-to-severe atopic dermatitis (AD). The findings mark an important step toward expanding treatment options for paediatric patients with this chronic inflammatory skin disease.
Dosing and Pharmacokinetics: How Stapokibart Works in Children
Stapokibart is already approved for adults with moderate-to-severe AD, but its use in younger populations has not previously been evaluated. This phase 1b/2a open-label, single-arm study (NCT06162507) assessed the drug’s safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity in a cohort of 25 children across multiple centres in China.
Participants were assigned weight-based dosing: those weighing 30–60 kg received 300 mg every three weeks (with a 600 mg loading dose), while children weighing 15–30 kg received 150 mg every two weeks (with a 300 mg loading dose). All patients underwent eight weeks of treatment followed by an eight-week observation period.
Overall, stapokibart was well tolerated. Mild or moderate adverse events occurred in 68% of participants, with no severe treatment-related reactions and no new safety signals. Importantly, no anti-drug antibodies were detected during the study, suggesting low immunogenicity.
Trial Findings Support Further Research into Stapokibart for AD
Efficacy outcomes were encouraging. By week 8, more than half (53.8%) of children in the higher-weight group and three-quarters (75.0%) in the lower-weight group achieved EASI-75, a benchmark indicating at least a 75% improvement in eczema severity. Pharmacokinetic analyses showed rapid increases in stapokibart levels after the first dose, with further accumulation over the treatment period and expected declines after discontinuation. Reductions in inflammatory biomarkers supported the clinical improvements observed.
While the sample size was small and the trial lacked a comparator arm, the results suggest that stapokibart could become a valuable addition to paediatric AD therapy. The authors stress that larger, controlled studies will be essential to confirm long-term safety and efficacy, but the early data signal meaningful promise for children with limited treatment options.
Reference
Zhao M et al. Safety and efficacy of stapokibart, an anti–IL-4Rα monoclonal antibody, in children aged 6–11 years with moderate-to-severe atopic dermatitis: An open-label, single-arm phase 1b/2a trial. Br J Dermatol. 2025;DOI:10.1093/bjd/ljaf455.
