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Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis
Sponsor: Lingli Dong
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.
Official title: Efficacy and Safety of Xeligekimab in the Treatment of Non-Radiographic Axial Spondyloarthritis: A Single-Center, Single-Arm Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-01-31
Completion Date
2028-01-30
Last Updated
2026-01-14
Healthy Volunteers
No
Interventions
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 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.
Locations (1)
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China