Xeligekimab injection: Subjects who have signed the informed consent form will undergo examinations and assessments according to the inclusion/exclusion criteria specified in the trial protocol. After screening and successful enrollment, they will enter the treatment period. Dosing time points are (W0, W2, W4, W8, W12), with a subcutaneous injection of Xeligekimab 100mg each time. Week 12 is the last dosing time. After week 12, the physician will comprehensively assess whether to continue using Xeligekimab based on the patient's condition. If continuation is required, the patient will need to purchase Xeligekimab at their own expense.
During the trial, the research physician and nurse will monitor safety, record the subject's vital signs and adverse events after dosing. Laboratory tests will be performed before and after the trial.
Study summary
Subjects who have signed the informed consent form will undergo examinations and assessments according to the inclusion/exclusion criteria specified in the trial protocol. After screening and successful enrollment, they will enter the treatment period. Dosing time points are (W0, W2, W4, W8, W12), with a subcutaneous injection of Xeligekimab 100mg each time. Week 12 is the last dosing time. After week 12, the physician will comprehensively assess whether to continue using Xeligekimab based on the patient's condition. If continuation is required, the patient will need to purchase Xeligekimab at their own expense.
During the trial, the research physician and nurse will monitor safety, record the subject's vital signs and adverse events after dosing. Laboratory tests will be performed before and after the trial.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Male or female patients aged 18 years or older;
* Diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) criteria for axial spondyloarthritis;
* Ineffective or intolerant to NSAID therapy;
* Objective signs of inflammation (abnormal MRI or C-reactive protein);
* Active axial spondyloarthritis with BASDAI score ≥4 and BASDAI question 2 ≥4;
* Visual Analogue Scale (VAS) score ≥4;
Exclusion Criteria:
* Patients with radiographic evidence of sacroiliitis, bilateral ≥grade 2 or unilateral ≥grade 3;
* Presence of other active inflammations besides axial spondyloarthritis (e.g., active inflammatory bowel disease \[IBD\] or uveitis);
* Chest X-ray suggesting active infection or malignant lesions;
* Active systemic infection within 2 weeks prior to enrollment;
* Known tuberculosis, HIV, hepatitis B, or hepatitis C infection at screening;
* History of lymphoproliferative disease, any history of malignancy (within the past 5 years);
* Subjects with unstable cardiovascular disease;
* Patients taking potent opioid analgesics;
* Pregnant or lactating women.
Primary outcome measure(s)
Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12 — at the 12th week after administration ASAS20 response is defined as an improvement of
20% and an absolute improvement from baseline of 2 units on a 10-point scale in at least three of the four main domains and no worsening assessed at all in the remaining domain.
Main ASAS domains:
Patient's global assessment of disease activity measured on a VAS scale Patient's assessment of back pain, represented by either total or nocturnal pain scores, both measured on a VAS scale Function represented by BASFI average of 10 questions regarding ability to perform specific tasks as measured by VAS scale Inflammation represented by mean duration and severity of morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI as measured by VAS scale
Trial sites (1)
Facility
City
Region
Status
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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