What question did this study set out to answer?

The main aim is to assess the efficacy and safety of stapokibart in treating moderate-to-severe atopic dermatitis in adolescents.

February 19, 2026

View Full Paper

Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial

Key Points

The main aim is to assess the efficacy and safety of stapokibart in treating moderate-to-severe atopic dermatitis in adolescents.
Multicenter, randomized, double-blind, placebo-controlled phase 3 trial
Patients randomized to receive either stapokibart (300 mg) or placebo
Treatment duration of 18 weeks with subcutaneous administration every two to three weeks based on weight
Primary endpoints included EASI-75 response and IGA score at week 18
73.9% of stapokibart-treated patients achieved EASI-75 versus 43.3% in the placebo group
57.1% of stapokibart patients had IGA response compared to 25.0% in placebo
36.1% of patients experienced significant itch relief in the stapokibart group versus 15.0% in placebo
Adverse event incidence was similar (62.5% for stapokibart vs. 61.7% for placebo)

Abstract

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, while treatment options remain limited. Stapokibart, a novel humanized monoclonal antibody targeting IL-4Rα, has been approved for the treatment of adults with moderate-to-severe AD in China. 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 3 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 two weeks (q2w), while those weighting 30 to 60 kg received treatment every three weeks (q3w). All patients were given moisturizers during the whole study. Coprimary endpoints were 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 0/1 with ≥2-point reduction from baseline (IGA response) at week 18. The safety was also assessed. Results Of the 180 enrolled patients, 120 received stapokibart (54 q2w; 66 q3w) and 60 received placebo (26 q2w; 34 q3w). Totally 178 (98.9%) patients completed the double-blind treatment. At week 18, higher proportions of stapokibart- vs. placebo-treated patients achieved EASI-75 (73.9% 88/119 vs. 43.3% 26/60; difference 95%CI: 30.5% 15.3%, 44.3%; P0.0001) and an IGA response (57.1% 68/119 vs. 25.0% 15/60; difference 95%CI: 31.8% 16.6%, 44.4%; P0.0001). The proportion of patients achieving ≥4-point reductions in weekly average of daily Peak Pruritus Numerical Rating Scale score was also significantly higher in stapokibart group than in placebo group (36.1% 43/119 vs. 15.0% 9/60; difference 95%CI: 21.1% 7.4%, 32.4%; P=0.0037). The incidence of adverse events was similar between the stapokibart (62.5% 75/120) and placebo (61.7% 37/60) groups. No conjunctivitis was found. Conclusion Stapokibart demonstrated high efficacy and favorable safety in adolescents with moderate-to-severe AD.

KI fragen

Bookmark

View Full Paper

Cite This Study

Zhou et al. (Fri,) studied this question.

synapsesocial.com/papers/6996a7d3ecb39a600b3ede40 https://doi.org/https://doi.org/10.1093/bjd/ljag052

KI fragen

Bookmark

View Full Paper