Vunakizumab in Adults with Spondyloarthritis
ConditionSpondyloarthritis (SpA)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- vnacicizumab
Treatment groups
880 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov