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

NCT07339566 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-14

No results posted yet for this study

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.

Conditions

  • Nr-axial Spondyloarthritis
  • Non-Radiographical Axial Spondyloarthritis

Interventions

DRUG

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.

Sponsors & Collaborators

  • Lingli Dong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-06-30
Completion
2028-01-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07339566 on ClinicalTrials.gov