A multicenter, randomized, double-blinded, placebo-controlled, phase Ⅲ study evaluating the efficacy and safety of Xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis

• Published in: British journal of dermatology (1951) 2024-02
• Main Authors: Cai, Lin, Jiang, Congjun, Zhang, Guoqiang, Fang, Hong, Wang, Jinyan, Li, Yumei, Xu, Hui, Xiao, Rong, Ding, Yangfeng, Huang, Kun, Zhang, Chunlei, Zhang, Litao, Chen, Bin, Duan, Xinsuo, Pan, Weili, Han, Guangming, Chen, Rongyi, Liu, Lunfei, Zhang, Shoumin, Tao, Juan, Pang, Xiaowen, Yu, Jianbin, Wang, Huiping, Zhao, Yi, Li, Chengxin, Kang, Xiaojing, Qin, Lanying, Zhu, Xiaofang, Su, Juan, Li, Shanshan, Yang, Chunjun, Feng, Wenli, Lei, Tiechi, Jiang, Shan, Fang, Ruihua, Lin, Mao, Lu, Qianjin, Xu, Chunxing, Wang, Wei, Zhang, Jianzhong
• Format: Article
• Language: English
• ISSN: 1365-2133

Xeligekimab is a fully human monoclonal antibody that selectively neutralizes IL-17A and had shown potential efficacy in preliminary trials. To evaluate the efficacy and safety of Xeligekimab in Chinese patients with moderate-to-severe psoriasis. A total of 420 Chinese patients were randomized to 200 mg Xeligekimab every 2 weeks (n = 281) or placebo (n = 139) for the first 12 weeks, followed by extending the treatment schedule to GR1501 every 4 weeks for further 40 weeks. Efficacy was assessed by evaluating the Physician's Global Assessment (PGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75/90/100 improvement. The safety profile was also evaluated. At week 12, The PASI 75/90/100 were achieved in 90.7%/74.4%/30.2%% patients in GR1501 group compared with 8.6%/1.4%/0% patients in placebo group, respectively. The PGA 0/1 were achieved in 74.4% patients of GR1501 group and 3.6% patients in placebo group, respectively. The PASI 75 and PGA 0/1 maintained until week 52. No unexpected adverse events were observed. Xeligekimab showed high efficacy and is well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.