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Introduction <p>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.</p> Methods <p>In this multicenter, randomized, double-blind, phase&#xa0;II trial, 199 patients were assigned (1:1:1:1) to receive placebo (<i>n</i> = 49) or xeligekimab 100&#xa0;mg (<i>n</i> = 50), 150&#xa0;mg (<i>n</i> = 49), or 200&#xa0;mg (<i>n</i> = 51) every 4&#xa0;weeks for 12&#xa0;weeks. All participants then entered a 40-week extension receiving xeligekimab 200&#xa0;mg every 4 or 8&#xa0;weeks. The primary endpoint was a 75% reduction in the Psoriasis Area and Severity Index (PASI&#xa0;75) at week&#xa0;12. Secondary endpoints included PASI&#xa0;75, PASI&#xa0;90 (≥ 90% improvement), and a static Physician’s Global Assessment (sPGA) score of 0/1 (clear/almost clear) at week&#xa0;52. Safety, pharmacokinetics (PK), and anti-drug antibodies (ADA) were also assessed.</p> Results <p>At week&#xa0;12, PASI&#xa0;75 response rates for the 100, 150, and 200&#xa0;mg groups were 86.0%, 89.8%, and 88.2%, respectively, versus 2.0% for placebo (<i>P</i> &lt; 0.05). At week&#xa0;52, PASI&#xa0;75, PASI&#xa0;90, and sPGA&#xa0;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.</p> Conclusion <p>Xeligekimab demonstrated strong efficacy, sustained response, and favorable safety in patients with moderate-to-severe plaque psoriasis.</p> Trial Registration Number <p>ChiCTR1800017956.</p>

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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 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月15日

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

摘要

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.