Not Yet RecruitingPhase 4

Vunakizumab in Adults with Spondyloarthritis

880 participantsStarted 2025-01-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Proportion of patients with spondyloarthritis who achieved ASAS40 response

Timeframe: week 16

Trial details

NCT IDNCT06770088

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-10

Contact for this trial

Jieruo Gu

+86 13922280820 gujieruo@163.com

View on ClinicalTrials.gov More Spondyloarthritis (SpA) trials