[Translation] A randomized, double-blind, multicenter clinical trial to evaluate the efficacy, safety, and immunogenicity of different induction doses of GR1501 injection in patients with plaque psoriasis

评价GR1501注射液不同诱导治疗剂量在中、重度斑块状银屑病患者中的疗效。

[Translation]

To evaluate the efficacy of different induction treatment doses of GR1501 injection in patients with moderate to severe plaque psoriasis.

Start Date06 Dec 2023

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

CTR20233595 / Active, not recruitingPhase 1

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

[Translation] Multicenter clinical trial on the pharmacokinetics of GR1501 injection in different populations and at different dosages

主要目的： Part A/B：评价GR1501注射液在健康受试者中单剂皮下注射给药的药代动力学特征； Part C：评价GR1501注射液在老年受试者中单剂皮下注射给药的药代动力学特征；次要目的： Part A/B：评价GR1501注射液在健康受试者中单剂皮下注射给药的安全性；评价GR1501注射液在健康受试者中单剂皮下注射给药的免疫原性； Part C：评价GR1501注射液在老年受试者中单剂皮下注射给药的安全性；评价GR1501注射液在老年受试者中单剂皮下注射给药的免疫原性。

[Translation]

Primary objectives: Part A/B: To evaluate the pharmacokinetic characteristics of GR1501 injection after a single subcutaneous injection in healthy subjects; Part C: To evaluate the pharmacokinetic characteristics of GR1501 injection after a single subcutaneous injection in elderly subjects; Secondary objectives: Part A/B: To evaluate the safety of GR1501 injection after a single subcutaneous injection in healthy subjects; To evaluate the immunogenicity of GR1501 injection after a single subcutaneous injection in healthy subjects; Part C: To evaluate the safety of GR1501 injection after a single subcutaneous injection in elderly subjects; To evaluate the immunogenicity of GR1501 injection after a single subcutaneous injection in elderly subjects.

Start Date08 Nov 2023

Sponsor / Collaborator

Chongqing Genrix Biopharmaceutical Co., Ltd.

[+1]

NCT05881785 / CompletedPhase 3

A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.

Start Date13 Jun 2022

Sponsor / Collaborator

Zhixiang (Shanghai) Medical Technology Co., Ltd.

100 Clinical Results associated with Xeligekimab

100 Translational Medicine associated with Xeligekimab

100 Patents (Medical) associated with Xeligekimab

Literatures (Medical) associated with Xeligekimab

10 Sep 2024·Journal of clinical pharmacology

Population Pharmacokinetics of Xeligekimab: An Anti-IL-17A Monoclonal Antibody, in Patients with Moderate to Severe Plaque Psoriasis.

Article

Author: Shi, Haiyang ; Meng, Qingheng ; Liu, Hongxia ; Zhang, Lingxiao ; Wang, Wei ; Zheng, Qingshan ; Xu, Ling

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 (V_c/F), peripheral compartment volume (V_p/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 V_c/F was 25.8% and 49.8%, respectively. The elimination half-life (t_1/2) was approximately 28.5 days. CL/F was significantly influenced by factors such as body weight, age, gender, and baseline total protein. V_c/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.

14 Aug 2024·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

Author: Lin, Mao ; Li, Chengxin ; Liu, Lunfei ; Xu, Hui ; Su, Juan ; Zhang, Guoqiang ; Jiang, Congjun ; Yang, Chunjun ; Zhu, Xiaofang ; Chen, Bin ; Huang, Kun ; Zhang, Shoumin ; Feng, Wenli ; Chen, Rongyi ; Fang, Ruihua ; Han, Guangming ; Xiao, Rong ; Wang, Jinyan ; Pang, Xiaowen ; Tao, Juan ; Qin, Lanying ; Kang, Xiaojing ; Zhang, Litao ; Wang, Huiping ; Xu, Chunxing ; Jiang, Shan ; Lei, Tiechi ; Lu, Qianjin ; Li, Yumei ; Duan, Xinsuo ; Pan, Weili ; Ding, Yangfeng ; Wang, Wei ; Zhang, Jianzhong ; Fang, Hong ; Cai, Lin ; Zhao, Yi ; Yu, Jianbin ; Li, Shanshan ; Zhang, Chunlei

AbstractBackgroundXeligekimab (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.ObjectivesTo evaluate the efficacy and safety of xeligekimab in Chinese patients with moderate-to-severe psoriasis.MethodsA 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.ResultsAt 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.ConclusionsXeligekimab showed high efficacy and was well tolerated in Chinese patients with moderate-to-severe plaque psoriasis.

01 Nov 2020·BMJ OpenQ4 · MEDICINE

Randomised, double-blind, multicentre, phase Ⅰ/Ⅱ dose escalation and expansion trial of GR1501 in patients with plaque psoriasis: study protocol

Q4 · MEDICINE

ArticleOA

Author: Zhang, Jianzhong ; Fang, Yi ; Shen, Tiantian ; Niu, Suping ; Cai, Lin ; Wang, Qian ; Cui, Yimin ; Dong, Wenliang ; Zheng, Qingshan ; Xia, Lin ; Fu, Weixing ; Wang, Wei ; Fan, Huaying ; Nie, Xiaoyan ; Wang, Qi ; Wang, Jiaxue

IntroductionPsoriasis 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 analysisA 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 disseminationThe 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 numberChiCTR1800017956.

100 Deals associated with Xeligekimab

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Plaque psoriasis	CN	Chongqing Genrix Biopharmaceutical Co., Ltd.	20 Aug 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Axial Spondyloarthritis	NDA/BLA	CN	Chongqing Genrix Biopharmaceutical Co., Ltd.	04 Jan 2024
Lupus Nephritis	Phase 2	CN	Chongqing Genrix Biopharmaceutical Co., Ltd.	08 Feb 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR2100043223 (NEWS) Manual	Phase 3	Plaque psoriasis	420	赛立奇单抗注射液	(elrrchyklr) = jaorpontol crrmrqtjio (nqjzvfsskz ) Met View more	Positive	27 Aug 2024
				Placebo	(elrrchyklr) = iykmurhrwu crrmrqtjio (nqjzvfsskz ) Met View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Xeligekimab

Overview

Basic Info

Gene Sequence

Related

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation