Non-Radiographical Axial Spondyloarthritis, Nr-axial Spondyloarthritis
Conditions
Keywords
Nr-axSpA, Xeligekimab Injection, IL-17A
Brief 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. 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
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.
Sponsors
Lingli Dong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| The proportion of participants meeting the ASAS 5/6 response criteria. | week 12 | ASAS 5/6 response is defined as an improvement of ≥20% in at least five of all six domains. |
| The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). | 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. |
| The proportion of overall participants achieving an ASAS40 response at week 12. | 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. |
| The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores. | 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. |
| Incidents of AE、TRAE、SAE | up to 12 weeks | overall safety and tolerability of Xeligekimab. |
| The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI). | 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. |
Countries
China
Contacts
Primary ContactLingLi Dong, PhD
Outcome results
None listed