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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-Radiographical Axial Spondyloarthritis; Nr-axial Spondyloarthritis
• Intervention / Treatment: Drug: Xeligekimab injection

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: LingLi Dong, PhD; Phone Number: 086-XXXXXXXXXX; Email: tjhdongll@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: lingli Dong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Xeligekimab treatment; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving ASAS20 (ankylosing spondylitis disease activity score) at week 12	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	at the 12th week after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of overall participants achieving an ASAS40 response at 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.	week 12
The proportion of participants meeting the ASAS 5/6 response criteria.	ASAS 5/6 response is defined as an improvement of ≥20% in at least five of all six domains.	week 12
The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).	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.	week 12
The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).	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.	week 12
The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.	The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis.	week 12
Incidents of AE、TRAE、SAE	overall safety and tolerability of Xeligekimab.	up to 12 weeks

Collaborators and Investigators

• Sponsor: Lingli Dong

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 4, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Nr-axSpA; IL-17A; Xeligekimab Injection
• Additional Relevant MeSH Terms: Axial Spondyloarthritis; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Spinal Diseases; Spondylarthropathies; Ankylosis; Spondylarthritis; Spondylitis; Non-Radiographic Axial Spondyloarthritis
• Other Study ID Numbers: nr-axSpA--IL17Ai

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No