Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial

Clinical Snapshot

Key Findings

• P Value: P < 0.001 for both primary endpoints

• Effect Size: Absolute difference 30.5% for EASI 75, 31.8% for IGA response

• Primary Outcome: EASI 75 at week 18: 73.9% stapokibart vs 43% placebo; IGA 0/1 response: 57.1% vs 25%

• Nnt Or Sensitivity: NNT = 3.3 for EASI 75 response, NNT = 3.1 for IGA response

• Confidence Interval: EASI 75: 15.3-44.3%; IGA response: 16.6-44.4%

Clinical Application

Subcutaneous injection every 2-3 weeks is practical for specialist dermatology or immunology clinics Would require TGA approval and PBS listing. Fits within RACGP guidelines for specialist referral of severe atopic dermatitis. Comparable to existing biologics like dupilumab Adolescents with moderate-to-severe atopic dermatitis inadequately controlled with topical therapies

Abstract

BACKGROUND: Moderate-to-severe atopic dermatitis (AD) imposes a significant burden on adolescents and their families, leading to a substantial reduction in quality of life. Treatment options remain limited. Stapokibart, a novel humanized monoclonal antibody that targets interleukin-4Rα, has been approved in China for the treatment of adults with moderate-to-severe AD. OBJECTIVES: To evaluate the efficacy and safety of stapokibart in adolescents with moderate-to-severe AD. METHODS: In this randomized double-blind placebo-controlled phase III trial (NCT06277765), eligible patients were randomized (2 : 1) to stapokibart 300 mg (loading dose 600 mg) or placebo for 18 weeks. Patients with a baseline weight ≥ 60 kg received subcutaneous stapokibart or placebo every 2 weeks (Q2W), while those weighing 30 to < 60 kg received treatment every 3 weeks (Q3W). All patients were given moisturizers during the entire study period. Co-primary endpoints were the proportions of patients achieving a ≥ 75% improvement from baseline in Eczema Area and Severity Index (EASI 75) and an Investigator's Global Assessment (IGA) score of clear or almost clear (IGA 0 or 1) with ≥ 2-point reduction from baseline (IGA response) at week 18. Safety was also assessed. RESULTS: Of the 180 enrolled patients, 120 received stapokibart (Q2W, n = 54; Q3W, n = 66) and 60 received placebo (Q2W, n = 26; Q3W, n = 34). In total, 178 (98.9%) patients completed the double-blind treatment. At week 18, higher proportions of patients treated with stapokibart than those treated with placebo achieved EASI 75 [73.9% (n = 88/119) vs. 43% (n = 26/60); difference: 30.5% (95% confidence interval 15.3-44.3; P < 0.001)] and an IGA response [57.1% (n = 68/119) vs. 25% (n = 15/60); difference: 31.8% (95% confidence interval 16.6-44.4; P < 0.001)]. The proportion of patients achieving ≥ 4-point reductions in weekly average of daily Peak Pruritus Numerical Rating Scale score was also significantly higher in the stapokibart group than in the placebo group [36.1% (n = 43/119) vs. 15% (n = 9/60); difference: 21.1% (95% confidence interval 7.4-32.4; P = 0.004)]. The incidence of adverse events was similar between the stapokibart (62.5%; n = 75/120) and placebo (62%; n = 37/60) groups. No conjunctivitis was seen. CONCLUSIONS: Stapokibart has a high efficacy and favourable safety in adolescents with moderate-to-severe AD. An author video to accompany this article is available online. Atopic dermatitis is a long-term skin condition. It causes intense itching and painful patches of dry skin. It is more commonly known as eczema. Adolescents with moderate or severe eczema often need long-term treatment to control the symptoms. In China, a drug called ‘stapokibart’ has recently been approved to treat adults with moderate or severe eczema. This study was done in 32 hospitals in China. We included adolescents with moderate or severe eczema. We treated them with stapokibart or placebo (an inactive or ‘dummy’ medication) for 18 weeks. The patients received their treatment via an injection under their skin. Depending on their weight at the start of the study, patients received treatment every 2 or every 3 weeks. After 18 weeks, patients treated with stapokibart were less itchy and had more of an improvement in their skin than those treated with the placebo. Over half of the patients achieved clear (or almost clear) skin. Finally, we found that stapokibart was safe to take. Undesired results from taking the medication (called ‘adverse events’) were mild or moderate. Our results suggest that stapokibart is an effective and safe treatment option for adolescents with moderate or severe eczema.

References

1. 1.Zhou, C., Zhao, Y., Zhu, G., Wu, L., Liu, Y., Tao, X., Zhao, H., Wei, Z., Lu, W., Li, W., Ding, Y., Zhu, X., Hu, G., Cheng, H., Xiao, R., Man, X.-Y., Wang, Q., Li, S., Zeng, T., Wang, L., Xu, Y., Zhang, L., Liu, W., Zhao, G., Jia, Y., Huang, Y., Chen, B., & Zhang, J. (2026). Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial. *British Journal of Dermatology*. https://doi.org/10.1093/bjd/ljag052