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

Lingli Dong

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Non-Radiographical Axial Spondyloarthritis; Nr-axial Spondyloarthritis

Treatments: Drug: Xeligekimab injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07339566

nr-axSpA--IL17Ai

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Xeligekimab treatment

Experimental group

Description:

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.

Treatment:

Drug: Xeligekimab injection