Primary objective:~• To demonstrate equivalent efficacy of BAT2306 and Cosentyx® in patients with moderate to severe plaque psoriasis.~Secondary objectives:~To evaluate the efficacy of BAT2306 compared with Cosentyx over the study period based on secondary efficacy endpoints.~To evaluate the safety and tolerability of BAT2306 compared with Cosentyx over the study period.~To evaluate the immunogenicity of BAT2306 compared with Cosentyx over the study period.~To evaluate the steady-state pharmacokinetics (PK) of BAT2306 compared with Cosentyx.~To assess safety and immunogenicity after transition from Cosentyx to BAT2306.
This study is a multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare efficacy, safety, immunogenicity, and PK of BAT2306 with Cosentyx in patients with moderate to severe plaque psoriasis.~The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (Treatment Period 1 [TP1]), and a 28-week secondary treatment period (Treatment Period 2 [TP2]). The study will be a maximum of 56 weeks.