The British journal of dermatology · 2026
Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zhou Cheng, Zhao Yan, Zhu Guannan, Wu Liming, Liu Yi, Tao Xiaohua, Zhao Hengguang, Wei Zhu, Lu Wei, Li Weiquan, Ding Yangfeng, Zhu Xiaohong, Hu Guohong, Cheng Hao, Xiao Rong, Man Xiao-Yong, Wang Qi, Li Shanshan, Zeng Tongxiang, Wang Lihua, Xu Yufeng, Zhang Libo, Liu Wei, Zhao Guoqing, Jia Yingmin, Huang Yanqiu, Chen Bo, Zhang Jianzhong
Аннотация
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.
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.