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Clinical Trial
. 2025 May 19;26(1):107.
doi: 10.1186/s40360-025-00885-4.

Safety, pharmacokinetics, preliminary efficacy, pharmacodynamics, and immunogenicity of QX002N, an anti-IL-17A monoclonal antibody, after short-term treatment of active ankylosing spondylitis

Min Wu  1 , Qianqian Li  1 , Min Fang  2 , Hong Zhang  1 , Yanhua Ding  3
Affiliations
Clinical Trial

Safety, pharmacokinetics, preliminary efficacy, pharmacodynamics, and immunogenicity of QX002N, an anti-IL-17A monoclonal antibody, after short-term treatment of active ankylosing spondylitis

Min Wu et al. BMC Pharmacol Toxicol. .

Abstract

Background: To investigate the safety, pharmacokinetics, preliminary efficacy, pharmacodynamics, and immunogenicity of QX002N, an interleukin-17 A monoclonal antibody, in Chinese patients with active ankylosing spondylitis (AS).

Methods: In this phase 1b, double-blind, placebo-controlled, multiple ascending dose study, eligible patients with active AS were randomized into three dose (40, 80, or 160 mg) cohorts, with a 4:1 ratio in each cohort to subcutaneously receive either QX002N or a placebo once every 2 weeks with six doses in total. All patients were followed for 14 weeks (98 days) after the last dose. The primary endpoints were the safety and pharmacokinetics of QX002N, and the secondary endpoints included its preliminary efficacy, pharmacodynamics, and immunogenicity.

Results: Thirty patients (n = 10 in each cohort) were included, with 24 receiving QX002N and 6 receiving a placebo. A total of 85 adverse drug reactions, predominantly Grade 1-2, were identified in 20 out of 24 patients (83.3%) who took QX002N. The exposure to QX002N increased proportionally with the dose escalating from 40 mg to 160 mg. Patients taking 160 mg QX002N achieved higher response rates (ASAS20: 87.6% at Week 8 [Day 56]); ASAS40: 50.0% at Week 12 [Day 78]), than those taking 40-mg or 80-mg QX002N. An increase in interleukin-17 A and a decrease in interleukin-6 levels in the serum, with decreases in the erythrocyte sedimentation rate and high-sensitivity C-reactive protein levels, were observed. Anti-drug antibodies were detected in only one of 24 patients taking QX002N.

Conclusions: Subcutaneous administration of QX002N demonstrates a favorable safety profile, with linear pharmacokinetic characteristics. Promising clinical responses in pharmacodynamics and preliminary efficacy have been observed. Immunogenicity does not appear to be a concern.

Trial registration: This study was registered with Chinadrugtrials.org.cn (CTR20201277), the data of registration was in 20 Jul, 2020.

Keywords: Anti-IL-17A monoclonal antibody; Efficacy; Immunogenicity; Pharmacokinetics; QX002N; Safety.

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Conflict of interest statement

Declarations. Ethical approval: The study was approved by Ethics Committee of the First Hospital of Jilin University (approval number: 20Y116-001) and conducted in accordance with the Declaration of Helsinki and the Guidelines for Good Clinical Practice. Written informed consent was obtained from each participant before the study commenced. Consent to participate: All participants provided written informed consent for this study. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Percentage of patients achieving ASAS20 and ASAS40 responses in different treatment cohorts. (A) ASAS20 response rate; (B) ASAS40 response rate. X axis: Time after administration (week); Y axis: Percentage of patients achieving ASAS20 or ASAS40 responses
Fig. 3
Fig. 3
Changes in the levels of hsCRP, ESR, I-17, and IL-6 in different treatment cohorts. (A) hsCRP; (B) ESR; (C) IL-17; (D) IL-6. hsCRP, high-sensitivity C-reactive protein; ESR, erythrocyte sedimentation rate; IL-17, interleukin-17; IL-6, interleukin-6
Fig. 4
Fig. 4
Mean concentration-time curves with standard deviation after subcutaneous injection of multiple ascending doses of QX002N. (A) Liner scale for multiple ascending dose; (B) Log scale for multiple ascending dose study; (C) Liner scale for the last dose; (D) Log scale for the last dose
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References

    1. Sieper J, Poddubnyy D, Axial spondyloarthritis. Lancet. 2017;390:73–84. 10.1016/s0140-6736(16)31591-4. - PubMed
    1. Ranganathan V, Gracey E, Brown MA, Inman RD, Haroon N. Pathogenesis of ankylosing spondylitis - recent advances and future directions. Nat Rev Rheumatol. 2017;13:359–67. 10.1038/nrrheum.2017.56. - PubMed
    1. Lata M, Hettinghouse AS, Liu CJ. Targeting tumor necrosis factor receptors in ankylosing spondylitis. Ann N Y Acad Sci. 2019;1442:5–16. 10.1111/nyas.13933. - PMC - PubMed
    1. van der Heijde D, Ramiro S, Landewé R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, et al. 2016 Update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76:978–91. 10.1136/annrheumdis-2016-210770. - PubMed
    1. Ward MM, Deodhar A, Gensler LS, Dubreuil M, Yu D, Khan MA, Haroon N, Borenstein D, Wang R, Biehl A, et al. 2019 Update of the American college of rheumatology/spondylitis association of America/spondyloarthritis research and treatment network recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2019;71:1599–613. 10.1002/art.41042. - PMC - PubMed

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