更新于：2024-12-07
Xeligekimab
赛立奇单抗
更新于：2024-12-07
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 中国 (2024-08-20), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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序列信息
Sequence Code 616717864H
来源: *****
Sequence Code 616717865L
来源: *****
关联
14
项与 赛立奇单抗 相关的临床试验一项评价GR1501注射液不同诱导剂量在斑块状银屑病患者中的有效性、安全性和免疫原性的随机、双盲、多中心临床试验
GR1501注射液在不同人群、不同给药剂量下的药代动力学多中心临床试验
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis
100 项与 赛立奇单抗 相关的临床结果
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100 项与 赛立奇单抗 相关的转化医学
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100 项与 赛立奇单抗 相关的专利（医药）
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4
项与 赛立奇单抗 相关的文献（医药）2024-09-10JOURNAL OF CLINICAL PHARMACOLOGY
Population Pharmacokinetics of Xeligekimab: An Anti-IL-17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis.
Article
作者: Liu, Hongxia ; Zheng, Qingshan ; Wang, Wei ; Meng, Qingheng ; Xu, Ling ; Zhang, Lingxiao ; Shi, Haiyang
Xeligekimab, a recombinant fully human IgG4 monoclonal antibody, has been strategically developed to target IL-17A and is presently in the developmental phase for treating moderate to severe plaque psoriasis. This study aims to investigate the pharmacokinetic profile of Xeligekimab, utilizing data derived from clinical trials specifically conducted in Chinese patients. The study conducted a population pharmacokinetic (PopPK) analysis involving 614 patients with plaque psoriasis. Examined covariates encompassed demographics, baseline laboratory tests, anti-drug antibodies (ADA), injection site, and disease-related baseline characteristics. Model evaluation utilized goodness-of-fit, prediction-corrected visual prediction check, and bootstrap methods. The clinical significance of covariates statistically associated with Xeligekimab was assessed through simulation analysis. The PopPK model of Xeligekimab demonstrated characteristics of a two-compartment model with first-order absorption and linear elimination. Inter-individual variability (IIV) was estimated for clearance and volume of distribution. For a typical plaque psoriasis patient, the estimated values for absorption rate constant (Ka), apparent clearance (CL/F), central compartment volume (Vc/F), peripheral compartment volume (Vp/F), and inter-compartmental clearance (Q/F) was 0.225 per day, 2.223 L/day, 4.02 L, 4.13 L, and 1.11 L/day, respectively. The estimated IIV for CL/F and Vc/F was 25.8% and 49.8%, respectively. The elimination half-life (t1/2) was approximately 28.5 days. CL/F was significantly influenced by factors such as body weight, age, gender, and baseline total protein. Vc/F was significantly influenced by body weight, age, gender, and baseline albumin. However, the clinical relevance of these covariate effects on exposure parameters was determined to be limited.
2024-08-14The British journal of dermatology
A multicentre randomized double-blind placebo-controlled phase III study of the efficacy and safety of xeligekimab (GR1501) in patients with moderate-to-severe plaque psoriasis
Article
作者: Jiang, Congjun ; Duan, Xinsuo ; Han, Guangming ; Kang, Xiaojing ; Li, Yumei ; Liu, Lunfei ; Jiang, Shan ; Zhang, Jianzhong ; Zhang, Litao ; Chen, Bin ; Li, Chengxin ; Wang, Huiping ; Wang, Jinyan ; Zhu, Xiaofang ; Cai, Lin ; Wang, Wei ; Qin, Lanying ; Pang, Xiaowen ; Lin, Mao ; Su, Juan ; Zhao, Yi ; Xu, Chunxing ; Tao, Juan ; Li, Shanshan ; Zhang, Guoqiang ; Feng, Wenli ; Yu, Jianbin ; Zhang, Shoumin ; Ding, Yangfeng ; Chen, Rongyi ; Huang, Kun ; Xu, Hui ; Zhang, Chunlei ; Fang, Hong ; Yang, Chunjun ; Lei, Tiechi ; Xiao, Rong ; Fang, Ruihua ; Lu, Qianjin ; Pan, Weili
Abstract:
Background:
Xeligekimab (GR1501) is a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A and has shown potential efficacy in treating moderate-to-severe psoriasis in preliminary trials.
Objectives:
To evaluate the efficacy and safety of xeligekimab in Chinese patients with moderate-to-severe psoriasis.
Methods:
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 an extension of the treatment schedule to xeligekimab every 4 weeks for a further 40 weeks. Efficacy was assessed by evaluating achievement of Physician Global Assessment (PGA) 0/1 and 75%, 90% and 100% improvement in Psoriasis Area and Severity Index (PASI 75, PASI 90 and PASI 100, respectively). The safety profile was also evaluated.
Results:
At week 12, PASI 75, PASI 90 and PASI 100 were achieved in 90.7%, 74.4% and 30.2% of patients in the xeligekimab group vs. 8.6%, 1.4% and 0% of patients in the placebo group, respectively. PGA 0/1 was achieved in 74.4% patients in the xeligekimab group and 3.6% of patients in the placebo group. PASI 75 and PGA 0/1 were maintained until week 52. No unexpected adverse events were recorded.
Conclusions:
Xeligekimab showed high efficacy and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.
2020-11-01BMJ open4区 · 医学
Randomised, double-blind, multicentre, phase Ⅰ/Ⅱ dose escalation and expansion trial of GR1501 in patients with plaque psoriasis: study protocol
4区 · 医学
ArticleOA
作者: Dong, Wenliang ; Fan, Huaying ; Cai, Lin ; Nie, Xiaoyan ; Zhang, Jianzhong ; Wang, Qi ; Wang, Jiaxue ; Cui, Yimin ; Fu, Weixing ; Niu, Suping ; Wang, Wei ; Fang, Yi ; Wang, Qian ; Xia, Lin ; Zheng, Qingshan ; Shen, Tiantian
Introduction:
Psoriasis is a life-long, immune-mediated disease that greatly reduces the quality of life of patients. Plaque psoriasis is the most common form of psoriasis. Treatment options for plaque psoriasis with good tolerance and sufficient response remain profoundly limited. Based on mechanistic findings that suggest the key pathogenic role of interleukin (IL)-17 in plaque psoriasis, we hypothesise that GR1501, a new monoclonal antibody (IL-17A targeted), will be an efficacious treatment for plaque psoriasis. This phase I/II trial aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of GR1501.
Methods and analysis:
A multicentre, randomised, double-blind, phase I/II dose escalation and expansion trial will be conducted at four hospitals in China. In total, 226 patients with plaque psoriasis will be enrolled in the study, with 46 cases in the dose-escalation stage and 180 cases randomised to GR1501 or the placebo in a 3:1 ratio in the expansion cohort. The primary outcomes are safety and tolerability; the secondary outcomes include pharmacokinetics, immunogenicity and efficacy.
Ethics and dissemination:
The study is in accordance with the Declaration of Helsinki, and the ethics approvals of the protocol have been obtained from the ethics committees of all participating centres, including Peking University People’s Hospital, Chinese PLA General Hospital, The First Affiliated Hospital, College of Medicine, Zhejiang University and the Second Xiangya Hospital of Central South University. The findings of the study will be presented in published journals or at scientific conferences or meetings.
Trial registration number:
ChiCTR1800017956.
100 项与 赛立奇单抗 相关的药物交易
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 斑块状银屑病 | 中国 | 2024-08-20 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 中轴性脊柱关节炎 | 申请上市 | 中国 | 2024-01-04 | |
| 狼疮性肾炎 | 临床2期 | 中国 | 2023-02-08 |
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临床结果
临床结果
适应症
分期
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临床3期 | 420 | 築蓋淵糧網積鹽醖鑰淵(襯餘網觸鬱繭顧觸餘齋) = 窪艱窪積鬱積餘網構夢 鏇願襯鏇觸憲餘鹹醖觸 (築遞淵窪蓋廠壓製鑰構 ) 达到 更多 | 积极 | 2024-08-27 | |||
Placebo | 築蓋淵糧網積鹽醖鑰淵(襯餘網觸鬱繭顧觸餘齋) = 餘壓鬱願餘鏇範蓋積膚 鏇願襯鏇觸憲餘鹹醖觸 (築遞淵窪蓋廠壓製鑰構 ) 达到 更多 |
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