Xeligekimab（GR1501）治疗中重度斑块状银屑病患者的疗效和安全性研究：一项多中心、随机、双盲II期临床试验。

Investigation of the Efficacy and Safety of Xeligekimab (GR1501) in Patients with Moderate-to-Severe Plaque Psoriasis: A Multicenter, Randomized, Double-Blind Phase II Clinical.

作者信息

Cai Lin, Li Chengxin, Li Shanshan, Zhang Xiaodong, Wang Gang, Yu Jianbin, Huang Kun, Fang Hong, Ding Yangfeng, Wang Jinyan, Jiang Congjun, Lu Qianjin, Tao Juan, Zhang Jianzhong

机构信息

Department of Dermatology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.

Department of Dermatology, Chinese PLA General Hospital, Beijing, China.

出版信息

Dermatol Ther (Heidelb). 2025 Jun 15. doi: 10.1007/s13555-025-01450-x.

DOI:10.1007/s13555-025-01450-x

PMID:40517362

Abstract

INTRODUCTION

Psoriasis is a chronic inflammatory skin disease. This study evaluated the efficacy and safety of xeligekimab (GR1501), a novel anti-interleukin-17A (anti-IL-17A) monoclonal antibody, in Chinese patients with moderate-to-severe plaque psoriasis.

METHODS

In this multicenter, randomized, double-blind, phase II trial, 199 patients were assigned (1:1:1:1) to receive placebo (n = 49) or xeligekimab 100 mg (n = 50), 150 mg (n = 49), or 200 mg (n = 51) every 4 weeks for 12 weeks. All participants then entered a 40-week extension receiving xeligekimab 200 mg every 4 or 8 weeks. The primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI 75) at week 12. Secondary endpoints included PASI 75, PASI 90 (≥ 90% improvement), and a static Physician's Global Assessment (sPGA) score of 0/1 (clear/almost clear) at week 52. Safety, pharmacokinetics (PK), and anti-drug antibodies (ADA) were also assessed.

RESULTS

At week 12, PASI 75 response rates for the 100, 150, and 200 mg groups were 86.0%, 89.8%, and 88.2%, respectively, versus 2.0% for placebo (P < 0.05). At week 52, PASI 75, PASI 90, and sPGA 0/1 response rates remained high in both 4-week (98.8%, 83.3%, 77.4%) and 8-week (92.9%, 83.3%, 78.6%) groups. No dose-dependent safety issues or ADA positivity were observed.

CONCLUSION

Xeligekimab demonstrated strong efficacy, sustained response, and favorable safety in patients with moderate-to-severe plaque psoriasis.

TRIAL REGISTRATION NUMBER

ChiCTR1800017956.

摘要

引言

银屑病是一种慢性炎症性皮肤病。本研究评估了新型抗白细胞介素-17A（抗IL-17A）单克隆抗体希利吉单抗（GR1501）对中国中度至重度斑块状银屑病患者的疗效和安全性。

方法

在这项多中心、随机、双盲II期试验中，199例患者按1:1:1:1分配，分别接受安慰剂（n = 49）或希利吉单抗100 mg（n = 50）、150 mg（n = 49）或200 mg（n = 51），每4周一次，共12周。所有参与者随后进入为期40周的延长期，每4或8周接受200 mg希利吉单抗治疗。主要终点是第12周时银屑病面积和严重程度指数（PASI 75）降低75%。次要终点包括第52周时的PASI 75、PASI 90（改善≥90%）以及静态医师整体评估（sPGA）评分为0/1（清除/几乎清除）。还评估了安全性、药代动力学（PK）和抗药物抗体（ADA）。

结果

在第12周时，100 mg、150 mg和200 mg组的PASI 75缓解率分别为86.0%、89.8%和88.2%，而安慰剂组为2.0%（P < 0.05）。在第52周时，4周组（98.8%、83.3%、77.4%）和8周组（92.9%、83.3%、78.6%）的PASI 75、PASI 90和sPGA 0/1缓解率仍然很高。未观察到剂量依赖性安全问题或ADA阳性。