A Study to Assess the Efficacy and Safety of Burfiralimab (hzVSF-v13) and DMRD (Disease-modifying Antirheumatic Drug)

This study is a Phase 2a, multi-center, randomized, double-blind, placebo-controlled. Efficacy and safety of biweekly intravenous infusions of burfiralimab (hzVSF-v13), added to DMARD treatment as standard of care, is evaluated in comparison with placebo. Participants of either sex, aged, 18\~80years, are enrolled it they have moderate to severe RA and had an inadequate response to disease-modifying antirheumatic drug(DMARD) treatments. The study consists of a screening period for up to 4 weeks, a treatment period of 10 weeks. Eligible participants are randomized in a 1:1:1 ratio to 1 of the 3 treatment groups: 200mg burfiralimab (hzVSF-v13) + SOC (study group 1), 600mg burfiralimab (hzVSF-v13) + SOC (study group 2), or placebo + SOC (control group). The primary focus of the study is to evaluate preliminary of the 2 doses of burfiralimab (hzVSF-v13, 200mg to 600mg) administered by IV infusion biweekly for 10 weeks when compared to placebo in lowering disease activity in participants. Efficacy analyses evaluate disease and health-related quality of life improvements at week 12 and week 18. Safety is assessed at up to 18 weeks.