[Translation] A Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety of Bimekizumab in Chinese adult subjects with moderate to severe plaque psoriasis
主要目的:比较Bimekizumab皮下注射给药16周与安慰剂治疗中度至重度斑块状PSO研究受试者的有效性。
次要目的:评价Bimekizumab 与安慰剂相比治疗4周时的有效性:达到 PASI75 应答;
评价Bimekizumab与安慰剂相比治疗16周时的有效性:达到完全清除(PASI100);
根据 PSD (P-SIM) 应答评估,评价 Bimekizumab与安慰剂相比治疗16周时对瘙痒、疼痛和鳞屑的影响;
评估为期 16 周治疗期间 Bimekizumab 的安全性。
[Translation] Primary objective: To compare the efficacy of Bimekizumab administered subcutaneously for 16 weeks with placebo in the treatment of moderate to severe plaque PSO study subjects.
Secondary objectives: To evaluate the efficacy of Bimekizumab compared with placebo at 4 weeks: achieving PASI75 response;
To evaluate the efficacy of Bimekizumab compared with placebo at 16 weeks: achieving complete clearance (PASI100);
To evaluate the effect of Bimekizumab compared with placebo at 16 weeks on pruritus, pain and scaling as assessed by PSD (P-SIM) response;
To evaluate the safety of Bimekizumab during the 16-week treatment period.