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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12 [Срок оценки: at the 12th week after administration]

Вторичные конечные точки (6)

• The proportion of overall participants achieving an ASAS40 response at week 12. [Срок оценки: week 12]
• The proportion of participants meeting the ASAS 5/6 response criteria. [Срок оценки: week 12]
• The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). [Срок оценки: week 12]
• The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI). [Срок оценки: week 12]
• The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores. [Срок оценки: week 12]
• Incidents of AE、TRAE、SAE [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science an — Ухань

Идентификаторы

NCT: NCT07339566 · nr-axSpA--IL17Ai

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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