{
  "abstract": "Ankylosing spondylitis (AS) is an immune-mediated spondyloarthropathy with unmet clinical needs. We conducted a superiority, phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of XKH004, a humanized monoclonal antibody targeting interleukin-17A/F in active AS. Of 489 screened patients with inadequate response to conventional therapy, 166 were excluded based on predefined criteria. The remaining 323 eligible patients were randomized 1:1 via a centralized interactive web-response system to receive subcutaneous XKH004 160 mg every 4 weeks or placebo until week 16. All patients completed a 52-week follow-up period, comprising 44 weeks of open-label XKH004 treatment followed by an 8-week safety follow-up. Participants and investigators were blinded to treatment allocation. Efficacy analyses utilized the Cochran–Mantel–Haenszel test. The primary endpoint was the proportion of patients achieving an Assessment of SpondyloArthritis international Society ≥ 40% improvement (ASAS40) response at week 16; secondary endpoints included ASAS20/50, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, Ankylosing Spondylitis Quality of Life, and Ankylosing Spondylitis Disease Activity Score. At week 16, ASAS40 response was achieved by 45.4% with XKH004 ( n = 161) vs 19.4% with placebo ( n = 162; absolute difference, 95% confidence interval, 15.47–35.02; P < 0.001), with efficacy in the XKH004 group sustaining and further improving to 66.2% by week 52. Serious adverse events occurred in 1.2% and 2.5% of patients in the XKH004 and placebo groups, respectively. Overall, XKH004 was well tolerated and induced rapid, sustained improvements, supporting its potential as a novel therapeutic option for active AS. The trial was registered in the China Drug Experiment database (CTR20232310) and ClinicalTrials.gov (NCT07498634) and supported by the National Natural Science Foundation of China, National Key Research and Development Project, Shanghai Municipal Key Clinical Specialty, and Shanghai Science and Technology Development Funds.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Rheumatology and Immunology, National Key Laboratory for Immunity and Inflammation, Changzheng Hospital, Naval Medical University, Shanghai, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of Henan University of Science & Technology, Henan, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of Xiamen University, Fujian, China",
    "Department of Rheumatology and Immunology, Jining No.1 People's Hospital, Shandong, China",
    "Department of Rheumatology and Immunology, The First Hospital of Lanzhou University, Gansu, China",
    "Department of Rheumatology and Immunology, Xiangya Hospital of Central South University, Hunan, China",
    "Department of Rheumatology and Immunology, West China Hospital of Sichuan University, Sichuan, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of Nanchang University, Jiangxi, China",
    "Department of Rheumatology and Immunology, The People’s Hospital of Guangxi Zhuang Autonomous Region, Guangxi Zhuang Autonomous Region, China",
    "Department of Rheumatology and Immunology, The First Hospital of Jilin University, Jilin, China",
    "Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Jiangsu, China",
    "Department of Rheumatology and Immunology, Pingxiang People's Hospital, Jiangxi, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital), Anhui, China",
    "Department of Rheumatology and Immunology, Linyi People's Hospital, Shandong, China",
    "Department of Rheumatology and Immunology, Xuanwu Hospital, Capital Medical University, Beijing, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of Kunming Medical University, Yunnan, China",
    "Department of Rheumatology and Immunology, Shenzhen People's Hospital, Guangdong, China",
    "Department of Rheumatology and Immunology, Changzhou No.2 People's Hospital, Jiangsu, China",
    "Department of Rheumatology and Immunology, Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Hubei, China",
    "Department of Rheumatology and Immunology, Affiliated Hospital of North Sichuan Medical College, Sichuan, China",
    "Department of Rheumatology and Immunology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Zhejiang, China",
    "Department of Rheumatology and Immunology, Qingdao Municipal Hospital, Shandong, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of Bengbu Medical University, Anhui, China",
    "Department of Rheumatology and Immunology, The Second Hospital of Shanxi Medical University, Shanxi, China",
    "Department of Rheumatology and Immunology, Guangdong Provincial People's Hospital, Guangdong, China",
    "Department of Rheumatology and Immunology, Peking University Third Hospital, Beijing, China",
    "Department of Rheumatology and Immunology, Tianjin Medical University General Hospital, Tianjin, China",
    "Department of Rheumatology and Immunology, Cangzhou People's Hospital, Hebei, China",
    "Department of Rheumatology and Immunology, Hainan General Hospital, Hainan, China",
    "Department of Rheumatology and Immunology, Nanfang Hospital of Southern Medical University, Guangdong, China",
    "Department of Rheumatology and Immunology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangdong, China",
    "Department of Rheumatology and Immunology, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China",
    "Department of Rheumatology and Immunology, Hebei PetroChina Central Hospital, Hebei, China",
    "Department of Rheumatology and Immunology, Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia Autonomous Region, China",
    "Department of Rheumatology and Immunology, People's Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Uygur Autonomous Region, China",
    "Department of Rheumatology and Immunology, The Second Affiliated Hospital of Dalian Medical University, Liaoning, China",
    "Department of Rheumatology and Immunology, The First Affiliated Hospital of Soochow University, Jiangsu, China",
    "Kanova Biopharmaceutical Co., Ltd., Beijing, China",
    "Westlake University School of Medicine, Zhejiang, China",
    "Department of Rheumatology and Immunology, National Key Laboratory for Immunity and Inflammation, Changzheng Hospital, Naval Medical University, Shanghai, China; Correspondence:"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 45,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Ling Zhou"
    },
    {
      "affs": [
        0
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      "name": "Ran Yan"
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    {
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        0
      ],
      "name": "Songying Ye"
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    {
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        0
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      "name": "Juan Zhao"
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        1
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      "name": "Xiaofei Shi"
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        2
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      "name": "Guixiu Shi"
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    {
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        3
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      "name": "Shujie Li"
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    {
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        4
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      "name": "Yanfei Chen"
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    {
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        5
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      "name": "Hui Luo"
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    {
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        6
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      "name": "Yongtao Chen"
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    {
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        7
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      "name": "Rui Wu"
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    {
      "affs": [
        8
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      "name": "Jinying Lin"
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    {
      "affs": [
        9
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      "name": "Zhenyu Jiang"
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    {
      "affs": [
        10
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      "name": "Lingyun Sun"
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    {
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        11
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      "name": "Jiankang Hu"
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    {
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        12
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      "name": "Xiaomei Li"
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    {
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        13
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      "name": "Zhenchun Zhang"
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    {
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        14
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      "name": "Yi Zhao"
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    {
      "affs": [
        15
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      "name": "Jian Xu"
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    {
      "affs": [
        16
      ],
      "name": "Xiaoping Hong"
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    {
      "affs": [
        17
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      "name": "Lei Zhou"
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    {
      "affs": [
        18
      ],
      "name": "Lingli Dong"
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    {
      "affs": [
        19
      ],
      "name": "Guohua Yuan"
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    {
      "affs": [
        20
      ],
      "name": "Huaxiang Wu"
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    {
      "affs": [
        21
      ],
      "name": "Qian Xing"
    },
    {
      "affs": [
        22
      ],
      "name": "Yongjun Mei"
    },
    {
      "affs": [
        23
      ],
      "name": "Xiaoxia Wang"
    },
    {
      "affs": [
        24
      ],
      "name": "Yang Li"
    },
    {
      "affs": [
        25
      ],
      "name": "Rong Mu"
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    {
      "affs": [
        26
      ],
      "name": "Wei Wei"
    },
    {
      "affs": [
        27
      ],
      "name": "Zunfang Xu"
    },
    {
      "affs": [
        28
      ],
      "name": "Shudian Lin"
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    {
      "affs": [
        29
      ],
      "name": "Min Yang"
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    {
      "affs": [
        30
      ],
      "name": "Qingchun Huang"
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    {
      "affs": [
        31
      ],
      "name": "Qiong Fu"
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    {
      "affs": [
        32
      ],
      "name": "Wei Gou"
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    {
      "affs": [
        33
      ],
      "name": "Hongbin Li"
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    {
      "affs": [
        34
      ],
      "name": "Lijun Wu"
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    {
      "affs": [
        35
      ],
      "name": "Xiaodan Kong"
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    {
      "affs": [
        36
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      "name": "Jian Wu"
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    {
      "affs": [
        37
      ],
      "name": "Jianguo You"
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    {
      "affs": [
        37
      ],
      "name": "Ke Ren"
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    {
      "affs": [
        37
      ],
      "name": "Li Guo"
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    {
      "affs": [
        38
      ],
      "name": "Chen Dong"
    },
    {
      "affs": [
        39
      ],
      "name": "Huji Xu"
    }
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  "bibtex": "https://research.draconitic.com/paper/ap9rk90a37x78.bib",
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  "doi": "10.1016/j.hlife.2026.07.005",
  "fulltext_url": "http://www.sciencedirect.com/science/article/pii/S2949928326000532",
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  "landing_url": "https://doi.org/10.1016/j.hlife.2026.07.005",
  "language": "en",
  "licence": "CC-BY-NC-ND",
  "licence_label": "CC BY-NC-ND",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by-nc-nd/4.0/",
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      "2745|Spondyloarthritis Studies and Treatments"
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  "pdf_url": "https://www.sciencedirect.com/science/article/pii/S2949928326000532/pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-24",
  "publisher": "Elsevier",
  "ris": "https://research.draconitic.com/paper/ap9rk90a37x78.ris",
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      "first_seen": "2026-10-30T13:44:32Z",
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  "title": "Efficacy and safety of XKH004, a novel dual interleukin-17A/F inhibitory monoclonal antibody, in active ankylosing spondylitis: A 52-week phase 3 randomized study",
  "title_text": "Efficacy and safety of XKH004, a novel dual interleukin-17A/F inhibitory monoclonal antibody, in active ankylosing spondylitis: A 52-week phase 3 randomized study",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T13:44:32Z",
  "url": "https://research.draconitic.com/paper/ap9rk90a37x78",
  "venue": "hLife",
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