This is a multicenter, double-blind, randomized, parallel-group study to compare the efficacy,pharmacodynamics (PD), pharmacokinetics (PK), safety, and immunogenicity of BAT2506 versus Simponi® in participants with active PsA. The study will consist of up to 4-week Screening Period, a 52-week Treatment Period, and a 8-week Safety Follow-up Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
704
50mg/0.5mL
50mg/0.5mL
West China Hospital Sichuan University
Chengdu, China
ACR20
To demonstrate the equivalence of BAT2506 and Simponi® on ACR 20 response in participants with active PsA
Time frame: Week 8 for EMA or Week 14 for FDA and NMPA
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