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

ConditionsNr-axial SpondyloarthritisNon-Radiographical Axial Spondyloarthritis
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLingli Dong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Xeligekimab treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at the 12th week after administration

Secondary outcomes

1

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.

Time frame
week 12
2

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.

Time frame
week 12
3

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.

Time frame
week 12
4

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.

Time frame
week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lingli Dong

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: