Vunakizumab in Adults with Spondyloarthritis

NCT ID: NCT06770088

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 880 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-10
• Study Completion Date: 2027-12-31

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.

Conditions

Spondyloarthritis (SpA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

Vunakizumab

Group Type: ACTIVE_COMPARATOR

vnacicizumab

Intervention Type: DRUG

Vunakizumab 120 mg subcutaneous injection at baseline and week2, week4, then every other 4 weeks.

Interventions

vnacicizumab

Vunakizumab 120 mg subcutaneous injection at baseline and week2, week4, then every other 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Gu Jieruo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jieruo Gu

Role: CONTACT

gujieruo@163.com

+86 13922280820

Other Identifiers

KY-2024-371-01

Identifier Type: -

Identifier Source: org_study_id