[Translation] A Phase II, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, adaptive study to evaluate the efficacy and safety of Enpatoran in subjects with systemic lupus erythematosus and cutaneous lupus erythematosus (subacute cutaneous lupus erythematosus and/or discoid lupus erythematosus) who are receiving standard of care
主要目的:
基于CLASI-A,评价Enpatoran在降低疾病活动度方面的剂量-应答关系;
基于BICLA应答率,评价Enpatoran在降低疾病活动度方面的剂量-应答关系;
次要目的:
评价Enpatoran与安慰剂相比的安全性和耐受性;
评价Enpatoran与安慰剂相比,在患有活动性狼疮皮疹的狼疮受试者中的疾病控制方面的有效性;
证明Enpatoran与安慰剂相比,在第1天接受泼尼松≥10 mg的SLE受试者达到BICLA应答和具有临床意义的CS减少方面的作用;
评价Enpatoran与安慰剂相比,在以活动性狼疮皮疹为主的狼疮受试者中的疾病控制方面的有效性;
评价Enpatoran与安慰剂相比,在活动性SLE受试者中的疾病控制方面的有效性;
评价Enpatoran与安慰剂相比,在患有活动性狼疮皮疹的狼疮受试者中的患者报告的症状和功能状态方面的有效性;
评价Enpatoran与安慰剂相比,在活动性SLE受试者中患者报告的症状方面的有效性。
以及相关探索性目的。
[Translation] Primary objectives:
To evaluate the dose-response relationship of Enpatoran in reducing disease activity based on CLASI-A;
To evaluate the dose-response relationship of Enpatoran in reducing disease activity based on BICLA response rate;
Secondary objectives:
To evaluate the safety and tolerability of Enpatoran compared with placebo;
To evaluate the efficacy of Enpatoran compared with placebo in disease control in lupus subjects with active lupus rash;
To demonstrate that Enpatoran is more effective than placebo in patients receiving ≥10 days of prednisone on day 1. mg in achieving BICLA response and clinically meaningful CS reduction in SLE subjects;
Evaluate the effectiveness of Enpatoran compared with placebo in disease control in lupus subjects with active lupus rash;
Evaluate the effectiveness of Enpatoran compared with placebo in disease control in active SLE subjects;
Evaluate the effectiveness of Enpatoran compared with placebo in patient-reported symptoms and functional status in lupus subjects with active lupus rash;
Evaluate the effectiveness of Enpatoran compared with placebo in patient-reported symptoms in active SLE subjects.
And related exploratory objectives.