American journal of clinical dermatology · 2026
Efficacy and Safety of SSGJ-608 in Moderate-to-Severe Plaque Psoriasis: A Pivotal Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial.
СтатьяНазвание 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.
Han Ling, Qin Haihong, Lu Xiaonian, Zhang Litao, Li Linfeng, Han Hongfang, Wang Jinyan, Duan Xinsuo, Sun Dongjie, Yang Wenlin, Ren Hong, Wang Xiaohua, Ci Chao, Wang Yu, Han Xiuping, Yin Wenhao, Yu Chunshui, Zhang Min, Zhu Jianjian, Wu Liming, Meng Zudong, Zeng Tongxiang, Wang Huiping, Shan Yunyun, Ding Yangfeng, Feng Wenli, Zhang Xiaoli, Zhang Guoqiang, Guo Qing, Cheng Hao, Ji Chao, Fang Ruihua, Dong Xiuqin, Zhu Xiaofang, Lei Tiechi, Yang Xueyuan, Xiao Rong, Liu Zhijun, Tao Xiaohua, Chen Rixin, Lou Jing, Liu Yanli, Zhang Jing, Xu Jinhua
Аннотация
BACKGROUND: SSGJ-608 is a recombinant, humanized, immunoglobulin G1 monoclonal antibody that targets human interleukin-17A with high specificity and high affinity.
OBJECTIVE: We aimed to evaluate the efficacy and safety of SSGJ-608 in patients with moderate-to-severe psoriasis in China.
METHODS: Adult patients aged 18 years or older with moderate-to-severe plaque psoriasis were randomly assigned (2:2:1) to receive subcutaneous injections of placebo (placebo group), 80 mg of SSGJ-608 every 2 weeks after a starting dose of 160 mg at week 0 (608A group), or 160 mg of SSGJ-608 every 4 weeks (608B group). At week 12, patients in the 608A group received SSGJ-608 80 mg every 4 weeks, patients in the 608B group received SSGJ-608 160 mg every 8 weeks, and patients in the placebo group were re-allocated (1:1) to either the 608A or 608B group to receive 608 80 mg every 4 weeks (with an additional 160-mg loading dose of SSGJ-608 at week 12) or 160 mg every 8 weeks. All patients received treatment until week 48. The primary endpoints were a ≥75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI75) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.
RESULTS: A total of 458 patients were randomly assigned to either the 608A group (n = 184), the 608B group (n = 183), or the placebo group (n = 91). At week 12, compared with those in the placebo group, a greater proportion of patients in the 608A group and in the 608B group achieved the primary endpoints of PASI75 (95.1% vs 93.4% vs 8.8%) and sPGA of 0 or 1 (76.1% vs 67.2% vs 1.1%). At week 52, PASI75 was maintained by 93.7% in the 608A group and 93.6% in the 608B group, sPGA of 0 or 1 was maintained by 89.3% in the 608A group and 89.4% in the 608B group, PASI90 was maintained by 92.6% in the 608A group and 92.5% in the 608B group, respectively. Both treatment groups demonstrated a favorable safety profile, with no increase in risk observed with longer drug exposure.
CONCLUSIONS: SSGJ-608 showed rapid and robust clinical response at week 12 and through week 52, and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT05536726.
OBJECTIVE: We aimed to evaluate the efficacy and safety of SSGJ-608 in patients with moderate-to-severe psoriasis in China.
METHODS: Adult patients aged 18 years or older with moderate-to-severe plaque psoriasis were randomly assigned (2:2:1) to receive subcutaneous injections of placebo (placebo group), 80 mg of SSGJ-608 every 2 weeks after a starting dose of 160 mg at week 0 (608A group), or 160 mg of SSGJ-608 every 4 weeks (608B group). At week 12, patients in the 608A group received SSGJ-608 80 mg every 4 weeks, patients in the 608B group received SSGJ-608 160 mg every 8 weeks, and patients in the placebo group were re-allocated (1:1) to either the 608A or 608B group to receive 608 80 mg every 4 weeks (with an additional 160-mg loading dose of SSGJ-608 at week 12) or 160 mg every 8 weeks. All patients received treatment until week 48. The primary endpoints were a ≥75% improvement from baseline in the Psoriasis Area and Severity Index score (PASI75) and a static Physicians Global Assessment score of 0/1 (sPGA 0/1) at week 12.
RESULTS: A total of 458 patients were randomly assigned to either the 608A group (n = 184), the 608B group (n = 183), or the placebo group (n = 91). At week 12, compared with those in the placebo group, a greater proportion of patients in the 608A group and in the 608B group achieved the primary endpoints of PASI75 (95.1% vs 93.4% vs 8.8%) and sPGA of 0 or 1 (76.1% vs 67.2% vs 1.1%). At week 52, PASI75 was maintained by 93.7% in the 608A group and 93.6% in the 608B group, sPGA of 0 or 1 was maintained by 89.3% in the 608A group and 89.4% in the 608B group, PASI90 was maintained by 92.6% in the 608A group and 92.5% in the 608B group, respectively. Both treatment groups demonstrated a favorable safety profile, with no increase in risk observed with longer drug exposure.
CONCLUSIONS: SSGJ-608 showed rapid and robust clinical response at week 12 and through week 52, and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT05536726.