About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Xeligekimab injection
Treatment groups
Sponsors and collaborators
Lingli Dong
Lead sponsor
Tongji Hospital
Sponsor institution