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

NCT07339566 | Not Yet Recruiting Phase 2

• 1 other identifier: nr-axSpA--IL17Ai
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Non-Radiographical Axial Spondyloarthritis; Nr-axial Spondyloarthritis

Keywords

Nr-axSpA; Xeligekimab Injection; IL-17A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The proportion of overall participants achieving an ASAS40 response at week 12.

  week 12

• The proportion of participants meeting the ASAS 5/6 response criteria.

  week 12

• The change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

  week 12

• The change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI).

  week 12

• The change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) scores.

  week 12

Study Arms (1)

Xeligekimab treatment

EXPERIMENTAL

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

Interventions

Xeligekimab injection DRUG

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.

Xeligekimab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lingli Dong: lead

Study Sites (1)

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Non-Radiographic Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Central Study Contacts

LingLi Dong, PhD

CONTACT

086-XXXXXXXXXX; tjhdongll@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor;professor of medicine

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 14, 2026
• Study Start: January 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)