SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study

Lin Cai; Jing Chen; Liming Wu; Xinsuo Duan; Guoqiang Zhang; Yumei Li; Litao Zhang; Lanying Qin; Tongxiang Zeng; Xiaohua Wang; Jinyan Wang; Kun Huang; Hong Ren; Lunfei Liu; Yangfeng Ding; Yong Cui; Yunyun Shan; Jianyun Lu; Xiaohua Tao; Rixin Chen; Yin Tu; Min Yan; Xiaohong Zhu; Na Qiao; Zudong Meng; Yu Wang; Fang Cheng; Yanxia Yuan; Jianjian Zhu; Xiaoping Hu; Shuping Guo; Xiujuan Xia; Xiaoyong Man; Zhouwei Wu; Xuejun Chen; Guanzhi Chen; Yingxia He; Dong Lv; Yanyan Feng; Danqi Deng; Songmei Geng; Qing Guo; Wenli Feng; Xiulan Zhu; Yongjun Liu; Bingjiang Lin; Rushan Xia; Chunshui Yu; Juanli Fan; Mingkai Ji; Tiechi Lei; Wenlin Yang; Meiping Yang; Ying Gao; Weiquan Li; Meiying Jiang; Jing Lou; Yanli Liu; Cheng Zhou; Jianzhong Zhang

doi:10.3389/fimmu.2026.1810418

SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study

Lin Cai
, Jing Chen
, Liming Wu
, Xinsuo Duan
, Guoqiang Zhang
, Yumei Li
, Litao Zhang
, Lanying Qin
, Tongxiang Zeng
, Xiaohua Wang
, Jinyan Wang
, Kun Huang
, Hong Ren
, Lunfei Liu
, Yangfeng Ding
, Yong Cui
, Yunyun Shan
, Jianyun Lu
, Xiaohua Tao
, Rixin Chen

Yin Tu, Min Yan, Xiaohong Zhu, Na Qiao, Zudong Meng, Yu Wang, Fang Cheng, Yanxia Yuan, Jianjian Zhu, Xiaoping Hu, Shuping Guo, Xiujuan Xia, Xiaoyong Man, Zhouwei Wu, Xuejun Chen, Guanzhi Chen, Yingxia He, Dong Lv, Yanyan Feng, Danqi Deng, Songmei Geng, Qing Guo, Wenli Feng, Xiulan Zhu, Yongjun Liu, Bingjiang Lin, Rushan Xia, Chunshui Yu, Juanli Fan, Mingkai Ji, Tiechi Lei, Wenlin Yang, Meiping Yang, Ying Gao, Weiquan Li, Meiying Jiang, Jing Lou, Yanli Liu, Cheng Zhou, Jianzhong Zhang

Peking University
Central South University
Hangzhou First People's Hospital
Chengde Medical University
Hebei Medical University
Affiliated Hospital of Jiangsu University
Tianjin University of Traditional Chinese Medicine
Cangzhou People's Hospital
Jingzhou Central Hospital
Southern Medical University
University of Chinese Academy of Sciences
First Affiliated Hospital of Chongqing Medical University
First People's Hospital of Lianyungang
Zhejiang University
Shanghai Dermatology Hospital
China-Japan Friendship Hospital
Hangzhou Third People's Hospital
Zhejiang Provincial People's Hospital
Nanyang First People's Hospital
First Affiliated Hospital of Kunming Medical University
Shengli Oilfield Central Hospital
Wuxi Second People's Hospital
First People's Hospital of Qujing
Shiyan People's Hospital
Guizhou Medical University
Xingtai People's Hospital
The First People's Hospital of Changzhou
The First People’s Hospital of Changde City
Shanxi Medical University
Yantai Yuhuangding Hospital
Shanghai Jiao Tong University
Sichuan Provincial People's Hospital
Qingdao University
Panjin Liaoyou Gem Flower Hospital
Yancheng First People's Hospital
Chengdu Second People's Hospital
The Second Affiliated Hospital of Kunming Medical University
The Second Affiliated Hospital of Xi'an Jiaotong University
Sun Yat-sen Memorial Hospital of Sun Yat sen University
Second People's Hospital of Changzhi
Heilongjiang University of Traditional Chinese Medicine
Ningbo First Hospital
Jiangyin Hospital of Traditional Chinese Medicine
Suining Central Hospital
Yuncheng Central Hospital of Shanxi Province
Xiamen Medical College
Renmin Hospital of Wuhan University
Guangzhou Medical College
Jiangxi Provincial People's Hospital
The Central Hospital of Wuhan
Yue Bei People’s Hospital
Nanchang University
Ltd

科研成果: 期刊稿件 › 文章 › 同行评审

1 引用（Scopus）

摘要

Background: SSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity and has shown promising efficacy in treatment of moderate-to-severe psoriasis in preliminary trials. Objective: This multicenter, randomized, open-label, phase 3 trial aimed to further evaluate SSGJ-608 at different dosing intervals (80mg every two weeks and 160mg every four weeks) in patients with moderate-to-severe plaque psoriasis. Methods: A total of 770 patients with moderate to severe plaque psoriasis were randomly assigned (1:1) to receive subcutaneous injections of 80mg of SSGJ-608 every two weeks (Q2W) after a starting dose of 160mg at week 0(608A group), or 160mg of SSGJ-608 every four weeks (Q4W) (608 B group) for 12 weeks. Efficacy was assessed by PASI75 and sPGA 0 or 1 response rates at week 12 as co-primary endpoints, and proportion of patients who achieved PASI90, PASI100 or sPGA score of 0 at week 12 as secondary endpoints. The safety profile was also evaluated. Results: At week12, the proportions of patients achieving PASI75 (92.7% vs. 95.1%) and sPGA 0/1 (80.3% vs. 79.0%) were comparable between the two SSGJ-608 dose regimens. The PASI90, PASI100 and sPGA 0 response rates were 81.0% vs.82.3%, 49.4% vs. 47.5%, and 49.4% vs.47.3% in the 608A group and the 608B group, respectively. In the subgroup of patients previously treated with anti-IL-17 therapy, SSGJ-608 also achieved high clinical response rates at week12. The most common TEAEs were hypertriglyceridemia, upper respiratory tract infection, hyperuricemia, increased alanine aminotransferase and hypercholesterolemia. Both treatment groups demonstrated a favorable safety profile and no new safety signals were identified. Conclusions: SSGJ-608 was highly effective for treating patients with moderate-to-severe plaque psoriasis at 80mg Q2W and 160mg Q4W in a larger population, especially in patients previously treated with anti-IL-17 therapy, and exhibited a favorable tolerability profile in Chinese patients with moderate-to-severe plaque psoriasis. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT06299982.

源语言	英语
页（从-至）	1810418
页数	1
期刊	Frontiers in Immunology
卷	17
DOI	https://doi.org/10.3389/fimmu.2026.1810418
出版状态	已出版 - 2026
已对外发布	是

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Cai, L., Chen, J., Wu, L., Duan, X., Zhang, G., Li, Y., Zhang, L., Qin, L., Zeng, T., Wang, X., Wang, J., Huang, K., Ren, H., Liu, L., Ding, Y., Cui, Y., Shan, Y., Lu, J., Tao, X., ... Zhang, J. (2026). SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study. Frontiers in Immunology, 17, 1810418. https://doi.org/10.3389/fimmu.2026.1810418

@article{035d8214bdd64e07b6a0d358b8c94f0f,

title = "SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study",

abstract = "Background: SSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity and has shown promising efficacy in treatment of moderate-to-severe psoriasis in preliminary trials. Objective: This multicenter, randomized, open-label, phase 3 trial aimed to further evaluate SSGJ-608 at different dosing intervals (80mg every two weeks and 160mg every four weeks) in patients with moderate-to-severe plaque psoriasis. Methods: A total of 770 patients with moderate to severe plaque psoriasis were randomly assigned (1:1) to receive subcutaneous injections of 80mg of SSGJ-608 every two weeks (Q2W) after a starting dose of 160mg at week 0(608A group), or 160mg of SSGJ-608 every four weeks (Q4W) (608 B group) for 12 weeks. Efficacy was assessed by PASI75 and sPGA 0 or 1 response rates at week 12 as co-primary endpoints, and proportion of patients who achieved PASI90, PASI100 or sPGA score of 0 at week 12 as secondary endpoints. The safety profile was also evaluated. Results: At week12, the proportions of patients achieving PASI75 (92.7\% vs. 95.1\%) and sPGA 0/1 (80.3\% vs. 79.0\%) were comparable between the two SSGJ-608 dose regimens. The PASI90, PASI100 and sPGA 0 response rates were 81.0\% vs.82.3\%, 49.4\% vs. 47.5\%, and 49.4\% vs.47.3\% in the 608A group and the 608B group, respectively. In the subgroup of patients previously treated with anti-IL-17 therapy, SSGJ-608 also achieved high clinical response rates at week12. The most common TEAEs were hypertriglyceridemia, upper respiratory tract infection, hyperuricemia, increased alanine aminotransferase and hypercholesterolemia. Both treatment groups demonstrated a favorable safety profile and no new safety signals were identified. Conclusions: SSGJ-608 was highly effective for treating patients with moderate-to-severe plaque psoriasis at 80mg Q2W and 160mg Q4W in a larger population, especially in patients previously treated with anti-IL-17 therapy, and exhibited a favorable tolerability profile in Chinese patients with moderate-to-severe plaque psoriasis. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT06299982.",

keywords = "clinical trial, efficacy and safety, IL-17, plaque psoriasis, SSGJ-608",

author = "Lin Cai and Jing Chen and Liming Wu and Xinsuo Duan and Guoqiang Zhang and Yumei Li and Litao Zhang and Lanying Qin and Tongxiang Zeng and Xiaohua Wang and Jinyan Wang and Kun Huang and Hong Ren and Lunfei Liu and Yangfeng Ding and Yong Cui and Yunyun Shan and Jianyun Lu and Xiaohua Tao and Rixin Chen and Yin Tu and Min Yan and Xiaohong Zhu and Na Qiao and Zudong Meng and Yu Wang and Fang Cheng and Yanxia Yuan and Jianjian Zhu and Xiaoping Hu and Shuping Guo and Xiujuan Xia and Xiaoyong Man and Zhouwei Wu and Xuejun Chen and Guanzhi Chen and Yingxia He and Dong Lv and Yanyan Feng and Danqi Deng and Songmei Geng and Qing Guo and Wenli Feng and Xiulan Zhu and Yongjun Liu and Bingjiang Lin and Rushan Xia and Chunshui Yu and Juanli Fan and Mingkai Ji and Tiechi Lei and Wenlin Yang and Meiping Yang and Ying Gao and Weiquan Li and Meiying Jiang and Jing Lou and Yanli Liu and Cheng Zhou and Jianzhong Zhang",

note = "Publisher Copyright: Copyright {\textcopyright} 2026 Cai, Chen, Wu, Duan, Zhang, Li, Zhang, Qin, Zeng, Wang, Wang, Huang, Ren, Liu, Ding, Cui, Shan, Lu, Tao, Chen, Tu, Yan, Zhu, Qiao, Meng, Wang, Cheng, Yuan, Zhu, Hu, Guo, Xia, Man, Wu, Chen, Chen, He, Lv, Feng, Deng, Geng, Guo, Feng, Zhu, Liu, Lin, Xia, Yu, Fan, Ji, Lei, Yang, Yang, Gao, Li, Jiang, Lou, Liu, Zhou and Zhang.",

year = "2026",

doi = "10.3389/fimmu.2026.1810418",

language = "英语",

volume = "17",

pages = "1810418",

journal = "Frontiers in Immunology",

issn = "1664-3224",

publisher = "Frontiers Media SA",

}

Cai, L, Chen, J, Wu, L, Duan, X, Zhang, G, Li, Y, Zhang, L, Qin, L, Zeng, T, Wang, X, Wang, J, Huang, K, Ren, H, Liu, L, Ding, Y, Cui, Y, Shan, Y, Lu, J, Tao, X, Chen, R, Tu, Y, Yan, M, Zhu, X, Qiao, N, Meng, Z, Wang, Y, Cheng, F, Yuan, Y, Zhu, J, Hu, X, Guo, S, Xia, X, Man, X, Wu, Z, Chen, X, Chen, G, He, Y, Lv, D, Feng, Y, Deng, D, Geng, S, Guo, Q, Feng, W, Zhu, X, Liu, Y, Lin, B, Xia, R, Yu, C, Fan, J, Ji, M, Lei, T, Yang, W, Yang, M, Gao, Y, Li, W, Jiang, M, Lou, J, Liu, Y, Zhou, C & Zhang, J 2026, 'SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study', Frontiers in Immunology, 卷 17, 页码 1810418. https://doi.org/10.3389/fimmu.2026.1810418

TY - JOUR

T1 - SSGJ-608 in moderate-to-severe plaque psoriasis

T2 - a multicenter, randomized, open-label, phase 3 study

AU - Cai, Lin

AU - Chen, Jing

AU - Wu, Liming

AU - Duan, Xinsuo

AU - Zhang, Guoqiang

AU - Li, Yumei

AU - Zhang, Litao

AU - Qin, Lanying

AU - Zeng, Tongxiang

AU - Wang, Xiaohua

AU - Wang, Jinyan

AU - Huang, Kun

AU - Ren, Hong

AU - Liu, Lunfei

AU - Ding, Yangfeng

AU - Cui, Yong

AU - Shan, Yunyun

AU - Lu, Jianyun

AU - Tao, Xiaohua

AU - Chen, Rixin

AU - Tu, Yin

AU - Yan, Min

AU - Zhu, Xiaohong

AU - Qiao, Na

AU - Meng, Zudong

AU - Wang, Yu

AU - Cheng, Fang

AU - Yuan, Yanxia

AU - Zhu, Jianjian

AU - Hu, Xiaoping

AU - Guo, Shuping

AU - Xia, Xiujuan

AU - Man, Xiaoyong

AU - Wu, Zhouwei

AU - Chen, Xuejun

AU - Chen, Guanzhi

AU - He, Yingxia

AU - Lv, Dong

AU - Feng, Yanyan

AU - Deng, Danqi

AU - Geng, Songmei

AU - Guo, Qing

AU - Feng, Wenli

AU - Zhu, Xiulan

AU - Liu, Yongjun

AU - Lin, Bingjiang

AU - Xia, Rushan

AU - Yu, Chunshui

AU - Fan, Juanli

AU - Ji, Mingkai

AU - Lei, Tiechi

AU - Yang, Wenlin

AU - Yang, Meiping

AU - Gao, Ying

AU - Li, Weiquan

AU - Jiang, Meiying

AU - Lou, Jing

AU - Liu, Yanli

AU - Zhou, Cheng

AU - Zhang, Jianzhong

N1 - Publisher Copyright: Copyright © 2026 Cai, Chen, Wu, Duan, Zhang, Li, Zhang, Qin, Zeng, Wang, Wang, Huang, Ren, Liu, Ding, Cui, Shan, Lu, Tao, Chen, Tu, Yan, Zhu, Qiao, Meng, Wang, Cheng, Yuan, Zhu, Hu, Guo, Xia, Man, Wu, Chen, Chen, He, Lv, Feng, Deng, Geng, Guo, Feng, Zhu, Liu, Lin, Xia, Yu, Fan, Ji, Lei, Yang, Yang, Gao, Li, Jiang, Lou, Liu, Zhou and Zhang.

PY - 2026

Y1 - 2026

N2 - Background: SSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity and has shown promising efficacy in treatment of moderate-to-severe psoriasis in preliminary trials. Objective: This multicenter, randomized, open-label, phase 3 trial aimed to further evaluate SSGJ-608 at different dosing intervals (80mg every two weeks and 160mg every four weeks) in patients with moderate-to-severe plaque psoriasis. Methods: A total of 770 patients with moderate to severe plaque psoriasis were randomly assigned (1:1) to receive subcutaneous injections of 80mg of SSGJ-608 every two weeks (Q2W) after a starting dose of 160mg at week 0(608A group), or 160mg of SSGJ-608 every four weeks (Q4W) (608 B group) for 12 weeks. Efficacy was assessed by PASI75 and sPGA 0 or 1 response rates at week 12 as co-primary endpoints, and proportion of patients who achieved PASI90, PASI100 or sPGA score of 0 at week 12 as secondary endpoints. The safety profile was also evaluated. Results: At week12, the proportions of patients achieving PASI75 (92.7% vs. 95.1%) and sPGA 0/1 (80.3% vs. 79.0%) were comparable between the two SSGJ-608 dose regimens. The PASI90, PASI100 and sPGA 0 response rates were 81.0% vs.82.3%, 49.4% vs. 47.5%, and 49.4% vs.47.3% in the 608A group and the 608B group, respectively. In the subgroup of patients previously treated with anti-IL-17 therapy, SSGJ-608 also achieved high clinical response rates at week12. The most common TEAEs were hypertriglyceridemia, upper respiratory tract infection, hyperuricemia, increased alanine aminotransferase and hypercholesterolemia. Both treatment groups demonstrated a favorable safety profile and no new safety signals were identified. Conclusions: SSGJ-608 was highly effective for treating patients with moderate-to-severe plaque psoriasis at 80mg Q2W and 160mg Q4W in a larger population, especially in patients previously treated with anti-IL-17 therapy, and exhibited a favorable tolerability profile in Chinese patients with moderate-to-severe plaque psoriasis. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT06299982.

AB - Background: SSGJ-608 is an anti-interleukin-17A monoclonal antibody with high specificity and high affinity and has shown promising efficacy in treatment of moderate-to-severe psoriasis in preliminary trials. Objective: This multicenter, randomized, open-label, phase 3 trial aimed to further evaluate SSGJ-608 at different dosing intervals (80mg every two weeks and 160mg every four weeks) in patients with moderate-to-severe plaque psoriasis. Methods: A total of 770 patients with moderate to severe plaque psoriasis were randomly assigned (1:1) to receive subcutaneous injections of 80mg of SSGJ-608 every two weeks (Q2W) after a starting dose of 160mg at week 0(608A group), or 160mg of SSGJ-608 every four weeks (Q4W) (608 B group) for 12 weeks. Efficacy was assessed by PASI75 and sPGA 0 or 1 response rates at week 12 as co-primary endpoints, and proportion of patients who achieved PASI90, PASI100 or sPGA score of 0 at week 12 as secondary endpoints. The safety profile was also evaluated. Results: At week12, the proportions of patients achieving PASI75 (92.7% vs. 95.1%) and sPGA 0/1 (80.3% vs. 79.0%) were comparable between the two SSGJ-608 dose regimens. The PASI90, PASI100 and sPGA 0 response rates were 81.0% vs.82.3%, 49.4% vs. 47.5%, and 49.4% vs.47.3% in the 608A group and the 608B group, respectively. In the subgroup of patients previously treated with anti-IL-17 therapy, SSGJ-608 also achieved high clinical response rates at week12. The most common TEAEs were hypertriglyceridemia, upper respiratory tract infection, hyperuricemia, increased alanine aminotransferase and hypercholesterolemia. Both treatment groups demonstrated a favorable safety profile and no new safety signals were identified. Conclusions: SSGJ-608 was highly effective for treating patients with moderate-to-severe plaque psoriasis at 80mg Q2W and 160mg Q4W in a larger population, especially in patients previously treated with anti-IL-17 therapy, and exhibited a favorable tolerability profile in Chinese patients with moderate-to-severe plaque psoriasis. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT06299982.

KW - clinical trial

KW - efficacy and safety

KW - IL-17

KW - plaque psoriasis

KW - SSGJ-608

UR - https://www.scopus.com/pages/publications/105043666693

U2 - 10.3389/fimmu.2026.1810418

DO - 10.3389/fimmu.2026.1810418

M3 - 文章

C2 - 42344898

AN - SCOPUS:105043666693

SN - 1664-3224

VL - 17

SP - 1810418

JO - Frontiers in Immunology

JF - Frontiers in Immunology

ER -

SSGJ-608 in moderate-to-severe plaque psoriasis: a multicenter, randomized, open-label, phase 3 study

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