ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1453

Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study

Ling Zhou1, Juan Zhao1, Lingyun Sun2, Xuan Zhang3, Xiaomei Li4, Jiankang Hu5, Lijun Wu6, Zhenyu Jiang7, Min Yang8, Xiaoxia Wang9, Yongjun Mei10, Qingchun Huang11, Yongtao Chen12, Yang Li13, Lingli Dong14, Hui Luo15, Li Guo16, Jianguo You16, Yunpeng Zhang16, Ke Ren16 and Huji Xu1, 1Shanghai Changzheng Hospital, Shanghai, China (People's Republic), 2Nanjing Drum Tower Hospital, Nanjing, China (People's Republic), 3Beijing Hospital, Beijing, China, 4The First Affiliated Hospital of University of Science and Technology of China, Anhui, China (People's Republic), 5Department of Rheumatology, Pingxiang People's Hospital, Pingxiang, China, Pingxiang, China (People's Republic), 6People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China (People's Republic), 7The First Hospital of Jilin University, Changchun, China (People's Republic), 8Nanfang Hospital, Guangzhou, China (People's Republic), 9Second Hospital of Shanxi Medical University, Taiyuan, China (People's Republic), 10The First Affiliated Hospital of Bengbu Medical College, Bengbu, China, 11The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China (People's Republic), 12West China Hospital, Sichuan University, Chengdu, China (People's Republic), 13Guangdong Provincial People's Hospital, Guangzhou, China (People's Republic), 14Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China (People's Republic), 15Xiangya Hospital, Central South University, Changsha, China (People's Republic), 16Kanova Biopharma, Zhejiang, China (People's Republic)

Meeting: ACR Convergence 2024

Keywords: , ,

Session Information

Date: Sunday, November 17, 2024

Title: SpA Including PsA – Treatment Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: XKH004, the first recombinant anti-human IL-17A/F humanized monoclonal antibody in China (also known as XKH004), shares the same therapeutic target as Bimekizumab from UCB pharma, the first biologic targeting IL-17 A/F (XKH004 is the second one worldwide). In the Phase 1 clinical trial, XKH004 demonstrated favorable safety and efficacy profiles in healthy volunteers. In this article, we present the results of a Phase 2 study of XKH004 (CTR20212135).

Methods: The AS patients included in the study met the 1984 New York criteria, were aged between 18 and 60 years, and had ≥4 scores of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and total back pain. Totally 140 patients were randomized in a 2:2:2:1 ratio to receive XKH004 at doses of 80, 160, or 320mg (with a loading dose of 320mg, followed by 160mg doses) or placebo. The primary endpoint was the Assessment of SpondyloArthritis International Society ≥40% improvement (ASAS40) response rate at week 16, while secondary endpoints included ASAS20 response rate, BASFI, BASDAI, BASMI, MASES, ΔCRP, ΔESR, total back pain, morning stiffness score, safety, and immunogenicity.

Results: At week 16, 50.4% of all patients in XHK004 group achieved ASAS40 at W16, showing a significant difference compared to the placebo group (25%) (P = 0.035). However, only the response rate of 80mg group (52.5%) was significantly higher than the placebo group (25.0%) (P=0.043).For endpoint of ASAS20, 70.0% of patients in the XKH004 80 mg group and 69.2% in the 320 mg group achieved it compared to 40.0% in the PBO group (P=0.025 and P=0.031, respectively), while no statistically significant difference was noted for the 160 mg group. There were significant differences in the ΔCRP and ΔESR between each XKH004 treatment group and the placebo group.

Regarding safety,59.2% patients in the XKH004 group experienced at least one treatment-emergent adverse event related to IMP, showing no statistically significant differences compared to the placebo group(55%) . SAEs were reported in 5 of 120 patients (4.2%) treated with XKH004, while only two SAEs were deemed to be drug-related. In this trial, no immunogenicity risk was observed across all dosage groups.

Conclusion: In patients with active AS, various dosages of XKH004 effectively improved disease activity. The safety and tolerability profile were favorable, and no immunogenicity risk was identified for up to 24 weeks.

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Disclosures: L. Zhou: None; J. Zhao: None; L. Sun: None; X. Zhang: None; X. Li: None; J. Hu: None; L. Wu: None; Z. Jiang: None; M. Yang: None; X. Wang: None; Y. Mei: None; Q. Huang: None; Y. Chen: None; Y. Li: None; L. Dong: Amgen Inc., 12, MITIGATE Committee Member; H. Luo: None; L. Guo: None; J. You: None; Y. Zhang: None; K. Ren: None; H. Xu: None.

To cite this abstract in AMA style:

Zhou L, Zhao J, Sun L, Zhang X, Li X, Hu J, Wu L, Jiang Z, Yang M, Wang X, Mei Y, Huang Q, Chen Y, Li Y, Dong L, Luo H, Guo L, You J, Zhang Y, Ren K, Xu H. Efficacy and Safety of the Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection (XKH004) in Patients with Active Ankylosing Spondylitis: Findings from a 24-Week, Phase 2 Multicenter, Randomized, Placebo-Controlled Study [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/efficacy-and-safety-of-the-recombinant-anti-human-il-17a-f-humanized-monoclonal-antibody-injection-xkh004-in-patients-with-active-ankylosing-spondylitis-findings-from-a-24-week-phase-2-multicenter/. Accessed .

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