A new early-phase clinical trial has found that Stapokibart may offer a safe and effective treatment option for children aged 6–11 years with moderate-to-severe atopic dermatitis (AD).
The study (phase 1b/2a; NCT06162507) enrolled 25 children across multiple centres in China. Participants were given weight-based dosing: children weighing 30–60 kg received 300 mg every three weeks (after a 600 mg loading dose), while those weighing 15–30 kg received 150 mg every two weeks (after a 300 mg loading dose). All patients completed eight weeks of treatment followed by an eight-week observation period.
Results showed that Stapokibart was generally well tolerated: mild or moderate adverse events occurred in 68% of participants, and there were no reports of severe treatment-related reactions or new safety signals. Importantly, no anti-drug antibodies were detected, indicating low immunogenicity in this pediatric population.
Efficacy outcomes were promising. By week 8, among the higher-weight group (30–60 kg), 53.8% achieved EASI-75 — defined as at least a 75% improvement in eczema severity. In the lower-weight group (15–30 kg), 75.0% reached EASI-75. Stapokibart levels in the body rose quickly after the first dose, further increased with repeated dosing, and declined as expected after treatment ended. Reductions in inflammatory biomarkers paralleled the clinical improvements.
While the small sample size and absence of a comparator arm limit the conclusions, the study’s data suggest that Stapokibart could become a valuable addition to paediatric AD therapy — potentially offering children with moderate-to-severe atopic dermatitis a new, effective and well-tolerated treatment option.
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