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 - PubMed (original) (raw)
Clinical Trial
. 2026 Jan;40(1):151-162.
doi: 10.1007/s40259-025-00750-0. Epub 2025 Nov 17.
Shangzhu Zhang 1 2 3 4, Dong Xu 1 2 3 4, Shujie Li 6, Xiaoxia Wang 7, Fenghong Yuan 8, Wei Gou 9, Baijie Xu 10, Lingyun Sun 11, Jieruo Gu 12, Dongmei Zhou 13, Xiaomei Li 14, Ning Kong 15, Yi Zhao 16, Jie Hao 17, Tianwang Li 18, Xiaoyun Fan 19, Qiang Shu 20, Hua Wei 21, Tao Jiang 22, Jing Yang 23, Long Qian 24, Hongsheng Sun 25, Xiaoyan Cai 26, Zhenyu Jiang 27, Guohua Yuan 28, Li Qin 29, Min Yang 30, Jian Xu 31, Wenqiang Fan 32, Li Sun 33, Hua Zhang 34, Chunyan Zhang 35, Ning Zhang 36, Zhanyun Da 37, Jiankang Hu 38, Jingchun Jin 39, Ju Liu 40, Lie Dai 41, Lingli Dong 42, Wei Wang 43, Xiaofeng Zeng 44 45 46 47
Affiliations
- PMID: 41247398
- PMCID: PMC12790509
- DOI: 10.1007/s40259-025-00750-0
Clinical Trial
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 et al. BioDrugs. 2026 Jan.
Abstract
Background: Xeligekimab 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.
Objective: This phase III trial aimed to investigate the efficacy and safety of xeligekimab in patients with radiographic axial spondyloarthritis (r-axSpA).
Methods: This 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.
Results: A 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.
Conclusion: Xeligekimab 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 registration: ClinicalTrials.gov identifier: NCT05881785 (Date: 21 May 2023).
© 2025. The Author(s).
Conflict of interest statement
Declarations. Conflict of Interest: Wei Wang was an employee of Chongqing Genrix Biopharmaceutical at the time of the study. The other authors have declared no conflict of interest. Availability of Data and Material: The data that support the findings of this study are not openly available for reasons of sensitivity, but are available from the corresponding author upon reasonable request. Ethical Approval: The study protocol and its amendments were reviewed and approved by the independent ethics committee or Institutional Review Board (IRB) at each center. The study was conducted in accordance with the principles outlined in the Declaration of Helsinki and the Council of International Organizations of Medical Sciences International Ethical Guidelines. Consent to Participate: Written informed consent was obtained from all enrolled patients. Consent for Publication: Not applicable. Code Availability: Not applicable. Author Contributions: All listed authors fulfill the ICMJE authorship criteria, have approved the final version for publication, and accept responsibility for the integrity of the work as a whole. All authors contributed to the study design, data analysis, and interpretation. The first draft of the manuscript was written by Shangzhu Zhang, and all authors commented on previous versions. All authors read and approved the final manuscript.
Figures
Fig. 1
Patients’ disposition through week 48. The number of patients completing or not completing treatment periods is calculated with the initial number of patients who were randomized to that group
Fig. 2
Response rate (NRI) for ASAS20 (a), ASAS40 (b), and ASAS5/6 (c) in the estimand population through week 48. *p<0.001, ^p<0.01, +p<0.05 vs. placebo. Missing values were handled using NRI. Data are presented as the proportion of patients achieving ASAS20 (a), ASAS40 (b), and ASAS5/6 (c) responses at each study visit through week 48 in the estimand population. Results are shown separately for patients receiving xeligekimab 100 mg, xeligekimab 200 mg, placebo-100 mg, and placebo-200 mg, illustrating treatment response trends over time. ASAS Assessment of SpondyloArthritis international Society, NRI Non-Responder Imputation
References
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