Vunakizumab in Adults with Spondyloarthritis (V SPA)

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 4

Conditions: Spondyloarthritis (SpA)

Treatments: Drug: vnacicizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06770088

KY-2024-371-01

Details and patient eligibility

About

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.

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

880 participants in 1 patient group

single arm

Active Comparator group

Description:

Vunakizumab

Treatment:

Drug: vnacicizumab