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

Authors

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

Published in

Frontiers in immunology. Volume 17. Pages 1810418. Epub Jun 09, 2026.

Abstract

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.
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.
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.
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.
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.
https://clinicaltrials.gov/, identifier NCT06299982.

PMID:
42344898
Bibliographic data and abstract were imported from PubMed on 25 Jun 2026.

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