[Translation] A Phase II, double-blind, dose-ranging, parallel-group, long-term extension study in subjects with subacute cutaneous lupus erythematosus, discoid lupus erythematosus, and/or systemic lupus erythematosus who completed treatment in the WILLOW (MS200569_0003) study , to evaluate the safety and effectiveness of Enpatoran
主要目的:评价enpatoran在SCLE、DLE和/或SLE受试者中的长期安全性和耐受性。
次要目的:评价enpatoran在SCLE、DLE和/或SLE受试者中的长期安全性和耐受性及疾病控制方面的长期有效性;
第三/探索性目的:评价enpatoran在SCLE、DLE和/或SLE受试者中的疾病控制方面的长期有效性;评价enpatoran在SLE受试者中的疾病控制方面的长期有效性;评价enpatoran在SCLE、DLE和/或SLE受试者中对患者报告的症状和功能状态方面的长期有效性;评价enpatoran在活动性SLE受试者中对患者报告的症状和功能状态方面的长期有效性;研究活动性SLE受试者中,Enpatoran对生物标志物的影响;研究Enpatoran对免疫细胞亚群和免疫球蛋白的影响;研究Enpatoran对PD生物标志物的影响;通过稀疏PK采样采集enpatoran血浆浓度数据;评价enpatoran对疫苗免疫状态的长期影响。评价Enpatoran对比安慰剂对活动性狼疮皮疹受试者红斑的影响。
[Translation] Primary Objective: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE.
Secondary objectives: To evaluate the long-term safety and tolerability and long-term effectiveness of enpatoran in subjects with SCLE, DLE and/or SLE in terms of disease control;
Tertiary/exploratory purpose: To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SCLE, DLE and/or SLE; to evaluate the long-term effectiveness of enpatoran in disease control in subjects with SLE; to evaluate the long-term effectiveness of enpatoran in disease control in subjects with SLE; Long-term effectiveness of enpatoran on patient-reported symptoms and functional status in subjects with SCLE, DLE, and/or SLE; To evaluate the long-term effectiveness of enpatoran on patient-reported symptoms and functional status in subjects with active SLE; Study The effect of Enpatoran on biomarkers in subjects with active SLE; study the effect of Enpatoran on immune cell subsets and immunoglobulins; study the effect of Enpatoran on PD biomarkers; collect enpatoran plasma concentration data through sparse PK sampling; To evaluate the long-term effects of enpatoran on vaccine immune status. To evaluate the effect of Enpatoran versus placebo on erythema in subjects with active lupus rash.