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Not yet recruiting NCT06770088

Vunakizumab in Adults with Spondyloarthritis

Phase IV Interventional Spondyloarthritis (SpA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: vnacicizumab.
Who it may be relevant to
Registry conditions: Spondyloarthritis (SpA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of patients with spondyloarthritis who achieved ASAS40 response [Time frame: week 16]
Secondary outcome measures (2)
  • The proportion of patients achieving ASAS20 [Time frame: Week 16]
  • Proportion of patients with spondyloarthritis who achieved ASAS20 response [Time frame: Week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06770088 · KY-2024-371-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗