Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis (NCT07339566) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis
China40 participantsStarted 2026-01-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12