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NCT Number: NCT07339566

Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis

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.

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Key information

Conditions

Nr-axial Spondyloarthritis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Non-Radiographic Axial Spondyloarthritis Non-Radiographical Axial Spondyloarthritis Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location contact

lingli Dong

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xeligekimab injection

Drug

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.

Primary outcomes

  1. Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12

    Time frame: 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

Secondary outcomes

  1. The proportion of overall participants achieving an ASAS40 response at week 12.

    Time frame: 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.

  2. The proportion of participants meeting the ASAS 5/6 response criteria.

    Time frame: week 12

    ASAS 5/6 response is defined as an improvement of

    ≥20% in at least five of all six domains.

  3. The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

    Time frame: week 12

    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.

  4. The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).

    Time frame: week 12

    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.

  5. The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.

    Time frame: week 12

    The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis.

  6. Incidents of AE、TRAE、SAE

    Time frame: up to 12 weeks

    overall safety and tolerability of Xeligekimab.

Study contacts

Contact information is provided by the study sponsor or research team.

LingLi Dong, PhD

CONTACT

[email protected]

086-XXXXXXXXXX

Sponsors and collaborators

Lead sponsor

Lingli Dong

Other

Registry information

Official study title

Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis: A Single-Center, Single-Arm Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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