Vunakizumab in Adults with Spondyloarthritis (V SPA)

January 10, 2025 updated by: Gu Jieruo, Sun Yat-sen University

A Prospective, Single-arm, Multicenter Study to Explore the Efficacy and Safety of Vunakizumab in Adults with Active Spondyloarthritis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

880

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: single arm
Vunakizumab
Drug: vnacicizumab
Vunakizumab 120 mg subcutaneous injection at baseline and week2, week4, then every other 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with spondyloarthritis who achieved ASAS40 response
Time Frame: week 16
Proportion of patients with spondyloarthritis who achieved ASAS40 response
week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients achieving ASAS20
Time Frame: Week 16
The proportion of patients achieving ASAS20
Week 16
Proportion of patients with spondyloarthritis who achieved ASAS20 response
Time Frame: Week 52
Proportion of patients with spondyloarthritis who achieved ASAS20 response
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2025

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY-2024-371-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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