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Not yet recruiting NCT07339566

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

Phase II / Phase III Interventional Nr-axial Spondyloarthritis Non-Radiographical Axial Spondyloarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xeligekimab injection.
Who it may be relevant to
Registry conditions: Nr-axial Spondyloarthritis, Non-Radiographical Axial Spondyloarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Xeligekimab injection
    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 th

Primary outcome measures

  • Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12 [Time frame: at the 12th week after administration]
Secondary outcome measures (6)
  • The proportion of overall participants achieving an ASAS40 response at week 12. [Time frame: week 12]
  • The proportion of participants meeting the ASAS 5/6 response criteria. [Time frame: week 12]
  • The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). [Time frame: week 12]
  • The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI). [Time frame: week 12]
  • The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores. [Time frame: week 12]
  • Incidents of AE、TRAE、SAE [Time frame: up to 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science an — Wuhan

Identifiers

NCT: NCT07339566 · nr-axSpA--IL17Ai

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗