This is a prospective, open-label, controlled, multiple centers, randonmized clinical trial. It compares the clinical efficacy and safety of vunakizumab ivarmacitinib and glucocorticoids in the treatment of active Takayasu's arteritis.
In this study, 180 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized in to the vunakizumab treatment group, ivarmacitinib treatment group and glucocorticoid treatment group. Patients will follow the same reduction steps for glucocorticoids. The primary endpoint is the percentage of patients who are in complete response at week 52. The efficacy will be evaluated at week 4, 12, 26, 38 and 52. Safety is also monitored during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Vanakizumab 240mg each 4 weeks taken subcutaneously with an additional injection at day 15
Ivarmacitinib 8mg daily taken orally
Prednisone taken daily according to preset tapering protocol
Beijing Anzhen Hospital Capital Medical University
Beijing, Beijing Municipality, China
Complete response rate at week 52
Percentage of patients with complete response at week 52
Time frame: week 52
Complete response at week 26
Percentage of patients with complete response at week 26
Time frame: week 26
Combined response rate of vunakizumab at week 26 and week 52
Percentage of patients with response treated with vunakizumab at week 26 and week 52
Time frame: week 26 and week 52
Combined response rate of ivarmacitinib at week 26 and week 52
Percentage of patients with response treated with ivarmacitinib at week 26 and week 52
Time frame: week 26 and week 52
Time to relapse
Time to relapse in each treatment group
Time frame: week 52
Time to event
Time to event (including relapse, discontinuation due to AE/SAE, treatment failure)
Time frame: week 52
Patient-Reported Outcomes
The comparison of PtGA and PhGA in each individual during the treatment in each group
Time frame: week 52
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