NCT07339566Not yet recruitingPhase 2/3
Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis
Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis: A Single-Center, Single-Arm Study
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 31 Jan 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Lingli Dong
- Diseases
- Ankylosing spondylitis
- NCT number
- NCT07339566
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 40
- From 31 Jan 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active systemic infection within 2 weeks prior to enrollment;
Other illness
- 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;
- 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;
Other
- Patients with radiographic evidence of sacroiliitis, bilateral ≥grade 2 or unilateral ≥grade 3;
- Patients taking potent opioid analgesics;
- Pregnant or lactating women.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.