Evidence map›Paper›PMID 41247398›Full record

Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026

Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study.

Shangzhu Zhang, Dong Xu, Shengyun Liu, Shujie Li, Xiaoxia Wang, Fenghong Yuan, Wei Gou, Baijie Xu, Lingyun Sun, Jieruo Gu and 32 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05881785 (A Randomized, Double-blind, Placebo-controlled, Phase III Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05881785 phase3completednot on this map

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

TypeinterventionalSponsorGenrix (Shanghai) Biopharmaceutical Co., Ltd.Ran2022 to 2024Enrolled465ConditionsAxial SpondyloarthritisArmsGR1501 low dose, GR1501 high dose, placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

42 authors.

Shangzhu ZhangDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
Dong XuDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
Shengyun LiuDepartment of Rheumatology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Shujie LiDepartment of Rheumatology, Jining No. 1 People's Hospital, Jining, China.
Xiaoxia WangDepartment of Rheumatology, Second Hospital of Shanxi Medical University, Taiyuan, China.
Fenghong YuanRheumatism immunity branch, Wuxi People's Hospital, Wuxi, China.
Wei GouDepartment of Rheumatology, Hebei PetroChina Central Hospital, Langfang, China.
Baijie XuRheumatology and Immunology Department, Jieyang People's Hospital, Jieyang, China.
Lingyun SunRheumatology and Immunology Department, Nanjing Drum Tower Hospital, Nanjing, China.
Jieruo GuRheumatology and Immunology Department, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Dongmei ZhouDepartment of Rheumatology and Immunology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Xiaomei LiRheumatology and Immunology Department, Anhui Provincial Hospital, Hefei, China.
Ning KongDepartment of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.
Yi ZhaoRheumatic Immunology Department, West China Hospital of Sichuan University, Chengdu, China.
Jie HaoDepartment of Rheumatology, CANGZHOU People's Hospital, Cangzhou, China.
Tianwang LiRheumatism Immunity Branch, Guangdong Second Provincial General Hospital, Guangzhou, China.
Xiaoyun FanDepartment of Rheumatology, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
Qiang ShuDepartment of Rheumatology, Qilu Hospital of Shandong University, Jinan, China.
Hua WeiRheumatology and Immunology Department, North Jiangsu People's Hospital, Yangzhou, China.
Tao JiangDepartment of Division of Rheumatology, Jilin Province People's Hospital, Changchun, China.
Jing YangRheumatic Immunology Department, Mianyang Central Hospital, Mianyang, China.
Long QianRheumatology and Immunology Department, The Second Affiliated Hospital of Anhui Medical University, Hefei, China.
Hongsheng SunRheumatology and Immunology Department, Shandong First Medical University Affiliated Provincial Hospital, Jinan, China.
Xiaoyan CaiDepartment of Rheumatology, Guangzhou First People's Hospital, Guangzhou, China.
Zhenyu JiangRheumatology and Immunology Department, First Hospital of Jilin University, Changchun, China.
Guohua YuanRheumatic Immunology Department, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.
Li QinRheumatism Immunity Branch, Huzhou Third Municipal Hospital, Huzhou, China.
Min YangRheumatology Department, Nanfang Hospital of Southern Medical University, Guangzhou, China.
Jian XuDepartment of Rheumatology and Immunology, First Affiliated Hospital of Kunming Medical University, Kunming, China.
Wenqiang FanDepartment of Rheumatology and Immunology, Xinxiang Central Hospital, Xinxiang, China.
Li SunRheumatology and Immunology Department, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Hua ZhangDepartment of Rheumatology, Zaozhuang Municipal Hospital (Affiliated Hospital of Jining Medical College), Zaozhuang, China.
Chunyan ZhangRheumatology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Ning ZhangDepartment of Rheumatology and Immunology, Shengjing Hospital of China Medical University, Shenyang, China.
Zhanyun DaRheumatism Immunity Branch, Affiliated Hospital of Nantong University, Nantong, China.
Jiankang HuDepartment of Rheumatology and Immunology, Pingxiang People's Hospital, Pingxiang, China.
Jingchun JinRheumatology and Immunology Department, Yanbian University Hospital (Yanbian Hospital), Yanbian, China.
Ju LiuRheumatology and Immunology Department, Jiujiang First People's Hospital, Jiujiang, China.
Lie DaiRheumatism Immunity Branch, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Lingli DongDepartment of Rheumatology and Immunology, Tongji Medical College of HUST, Wuhan, China.
Wei WangChongqing Genrix Biopharmaceutical Co., Ltd, Chongqing, China.
Xiaofeng ZengDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China. xiaofeng.zeng@cstar.org.cn.ORCID http://orcid.org/0000-0002-3883-2318

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundXeligekimab is a novel immunoglobulin G4 (IgG4) monoclonal antibody targeting interleukin-17A (IL-17A). In a phase III trial in patients with plaque psoriasis, xeligekimab showed efficacy and safety consistent with other IL-17A inhibitors, supporting its potential application in the treatment of spondyloarthritis.

objectiveThis phase III trial aimed to investigate the efficacy and safety of xeligekimab in patients with radiographic axial spondyloarthritis (r-axSpA).

methodsThis was a phase III study conducted at multiple centers in China. Eligible patients were randomly assigned (1:1:1) to receive xeligekimab 100 mg, xeligekimab 200 mg, or placebo. Randomization was stratified by medication history (biologic-experienced vs. biologic-naïve) and weight (≥ 70 kg vs. < 70 kg). The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis International Society 20 (ASAS20) response at week 16. A key secondary endpoint was the ASAS40 response rate at the same time point.

resultsA total of 465 patients were recruited. A significantly higher proportion of patients receiving xeligekimab 200 mg (n = 114 (74.0%); p < 0.001, 95% confidence interval (CI) 28.5-48.4) and xeligekimab 100 mg (n = 102 (65.8%); p < 0.001, 95% CI 19.4-41.0) achieved an ASAS20 response compared to the placebo group (n = 56 (35.9%)) at week 16. Similarly, a significantly higher ASAS40 response rate was observed in the xeligekimab 100 mg group (n = 62 (40.0%); p < 0.001) and the xeligekimab 200 mg group (n = 64 (41.6%); p < 0.001) compared to placebo. Adverse events were similar across all groups, with serious adverse events occurring in 1.6% of the treatment group during the core treatment period. No unexpected safety signals were reported through week 48.

conclusionXeligekimab demonstrated significant efficacy in improving the signs and symptoms of active r-axSpA in Chinese patients at week 16, with sustained effects observed through week 48 and no new safety signals identified.

trial registrationClinicalTrials.gov identifier: NCT05881785 (Date: 21 May 2023).

Indexed as

Antibodies, Monoclonal, HumanizedAxial SpondyloarthritisInterleukin-17AdultChinaDouble-Blind MethodEast Asian PeopleFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedIL17A protein, humanInterleukin-17

Identifiers

PMID41247398
PMCPMC12790509

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