Spondyloarthritis (SpA)
Conditions
Brief 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.
Interventions
DRUGvnacicizumab
Vunakizumab 120 mg subcutaneous injection at baseline and week2, week4, then every other 4 weeks.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with spondyloarthritis who achieved ASAS40 response | week 16 | Proportion of patients with spondyloarthritis who achieved ASAS40 response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving ASAS20 | Week 16 | The proportion of patients achieving ASAS20 |
| Proportion of patients with spondyloarthritis who achieved ASAS20 response | Week 52 | Proportion of patients with spondyloarthritis who achieved ASAS20 response |
Contacts
Primary ContactJieruo Gu
Outcome results
None listed