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NCT Number: NCT06770088

Vunakizumab in Adults with 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

vnacicizumab

Drug

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

Primary outcomes

  1. Proportion of patients with spondyloarthritis who achieved ASAS40 response

    Time frame: week 16

    Proportion of patients with spondyloarthritis who achieved ASAS40 response

Secondary outcomes

  1. The proportion of patients achieving ASAS20

    Time frame: Week 16

    The proportion of patients achieving ASAS20

  2. Proportion of patients with spondyloarthritis who achieved ASAS20 response

    Time frame: Week 52

    Proportion of patients with spondyloarthritis who achieved ASAS20 response

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Acronym: V SPA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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