Efficacy and Safety of SSGJ-608 in Moderate-to-Severe Plaque Psoriasis: A Pivotal Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial.
{"title":"Efficacy and Safety of SSGJ-608 in Moderate-to-Severe Plaque Psoriasis: A Pivotal Multicenter, Double-Blind, Placebo-Controlled, Randomized, Phase III Clinical Trial.","authors":"Ling Han, Haihong Qin, Xiaonian Lu, Litao Zhang, Linfeng Li, Hongfang Han, Jinyan Wang, Xinsuo Duan, Dongjie Sun, Wenlin Yang, Hong Ren, Xiaohua Wang, Chao Ci, Yu Wang, Xiuping Han, Wenhao Yin, Chunshui Yu, Min Zhang, Jianjian Zhu, Liming Wu, Zudong Meng, Tongxiang Zeng, Huiping Wang, Yunyun Shan, Yangfeng Ding, Wenli Feng, Xiaoli Zhang, Guoqiang Zhang, Qing Guo, Hao Cheng, Chao Ji, Ruihua Fang, Xiuqin Dong, Xiaofang Zhu, Tiechi Lei, Xueyuan Yang, Rong Xiao, Zhijun Liu, Xiaohua Tao, Rixin Chen, Jing Lou, Yanli Liu, Jing Zhang, Jinhua Xu","doi":"10.1007/s40257-026-01057-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>SSGJ-608 is a recombinant, humanized, immunoglobulin G1 monoclonal antibody that targets human interleukin-17A with high specificity and high affinity.</p><p><strong>Objective: </strong>We aimed to evaluate the efficacy and safety of SSGJ-608 in patients with moderate-to-severe psoriasis in China.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov Identifiers: NCT05536726.</p>","PeriodicalId":7706,"journal":{"name":"American Journal of Clinical Dermatology","volume":" ","pages":""},"PeriodicalIF":11.4000,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Clinical Dermatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40257-026-01057-8","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
The American Journal of Clinical Dermatology is dedicated to evidence-based therapy and effective patient management in dermatology. It publishes critical review articles and clinically focused original research covering comprehensive aspects of dermatological conditions. The journal enhances visibility and educational value through features like Key Points summaries, plain language summaries, and various digital elements, ensuring accessibility and depth for a diverse readership.
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