Vunakizumab in Adults with Spondyloarthritis

Phase 4

Not yet recruiting

• Conditions: Spondyloarthritis (SpA)
• Interventions: Drug: vnacicizumab

• Registration Number: NCT06770088
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This prospective, single-arm, multicenter study is aimed to explore the efficacy and safety of Vunakizumab in adults with spondyloarthritis. The primary endpoint is the proportion of adults with spondyloarthritis achieving ankylosing spondylitis assessment score (ASAS) 40 at week 16 in the treatment of Vunakizumab.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study Start: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2026-01-10
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 880

Inclusion Criteria

1. Patients older than 18 years when signing the informed consent;
2. Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;
3. The subjects voluntarily signed informed consent before the start of any procedures related to the study, were able to communicate with the investigators smoothly, understood and were willing to strictly abide by the requirements of the clinical research protocol to complete the study.

Exclusion Criteria

1. Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;
2. fertile women (defined as all women with the physical requirements for pregnancy) and men who are pregnant or who are unwilling or unable to use highly effective birth control during the study and within 20 weeks after last receiving the study drug;
3. active infection with important clinical significance;
4. patients with moderate to severe heart failure (NYHA class Ⅲ/Ⅳ);
5. patients with malignant tumors who were receiving treatment or were not receiving treatment;
6. concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to inflammatory bowel disease, which may affect the efficacy and safety evaluation according to the investigator's judgment;
7. any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	vnacicizumab	Vunakizumab

Primary Outcome Measures

Name	Time	Method
Proportion of patients with spondyloarthritis who achieved ASAS40 response	week 16	Proportion of patients with spondyloarthritis who achieved ASAS40 response

Secondary Outcome Measures

Name	Time	Method
The proportion of patients achieving ASAS20	Week 16	The proportion of patients achieving ASAS20
Proportion of patients with spondyloarthritis who achieved ASAS20 response	Week 52	Proportion of patients with spondyloarthritis who achieved ASAS20 response