Nr-axial SpondyloarthritisPhase 2/3NCT07339566
Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis
A Phase 2/3 study testing Xeligekimab injection in people with Nr-axial Spondyloarthritis and Non-Radiographical Axial Spondyloarthritis, run by Lingli Dong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nr-axial Spondyloarthritis, Non-Radiographical Axial Spondyloarthritis
- What is being tested?
- Xeligekimab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 30 Jan 2028
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- Subjects with unstable cardiovascular disease;
- Patients taking potent opioid analgesics;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000
lingli Dong
About this study
Official title: Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis: A Single-Center, Single-Arm Study
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.
- Being tested
- Xeligekimab injection
- Keywords
- Nr-axSpA, Xeligekimab Injection, IL-17A
- Medical subject headings
- Non-Radiographic Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeligekimab injectionDrug
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 group | Role | What they receive |
|---|---|---|
| Xeligekimab treatment | Experimental | Through the subcutaneous administration of Xeligekimab, it is hoped to achieve the control of symptoms and inflammation in nr-axSpA, prevent or delay structural damage, and maximize patients' quality of life. Receives: Drug: Xeligekimab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12
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
Measured: at the 12th week after administration
Secondary outcomes (6)
The proportion of overall participants achieving an ASAS40 response at week 12.
ASAS40 response is defined as an improvement of
40% 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.
Measured: week 12
The proportion of participants meeting the ASAS 5/6 response criteria.
ASAS 5/6 response is defined as an improvement of
≥20% in at least five of all six domains.
Measured: week 12
The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS.
Measured: week 12
The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).
The BASFI (Bath Ankylosing Spondylitis Functional Index) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS.
Measured: week 12
The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.
The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis.
Measured: week 12
Incidents of AE、TRAE、SAE
overall safety and tolerability of Xeligekimab.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nr-axial SpondyloarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lingli Dong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lingli Dong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339566
- Sponsor's protocol ID
- nr-axSpA--IL17Ai
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No