Vunakizumab in Adults with Spondyloarthritis

NCT06770088 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: KY-2024-371-01
• Study Type: interventional
• Target: 880
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with spondyloarthritis who achieved ASAS40 response

  Proportion of patients with spondyloarthritis who achieved ASAS40 response

  week 16

Secondary Outcomes (2)

• The proportion of patients achieving ASAS20

  Week 16

• Proportion of patients with spondyloarthritis who achieved ASAS20 response

  Week 52

Study Arms (1)

single arm

ACTIVE COMPARATOR

Vunakizumab

Drug: vnacicizumab

Interventions

vnacicizumab DRUG

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

single arm

Eligibility Criteria

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

You may qualify if:

• Patients older than 18 years when signing the informed consent;
• Patients diagnosed with spondyloarthritis (excluding psoriatic arthritis) and are eligible for biologic therapy;
• 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.

You may not qualify if:

• Patients with severe hypersensitivity reaction to the active ingredient or any excipient of Vunakizumab;
• 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;
• active infection with important clinical significance;
• patients with moderate to severe heart failure (NYHA class Ⅲ/Ⅳ);
• patients with malignant tumors who were receiving treatment or were not receiving treatment;
• 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;
• any other condition that the investigator considers would prevent the subject from adhering to and completing the study protocol.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Spondylarthritis

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Central Study Contacts

Jieruo Gu

CONTACT

+86 13922280820; gujieruo@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: January 10, 2025
• Primary Completion: January 10, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 13, 2025

Record last verified: 2024-12