[Translation] A phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of anifrolumab in Asian subjects with active systemic lupus erythematosus
主要目的:
根据第52周达到BICLA应答的受试者比例差异来评估anifrolumab与安慰剂相比对疾病活动度的影响。
关键次要目的:
评估anifrolumab与安慰剂相比对以下指标的影响:
基线OCS ≥ 10 mg/日的亚组受试者中,第40周时达到OCS剂量 ≤ 7.5 mg/日且维持至第52周的受试者比例;
第12周时,基线CLASI活动评分 ≥ 10的受试者亚组中皮肤红斑狼疮病面积和严重程度指数(CLASI)活动度评分降低 ≥ 50%的受试者比例;
52周内年化发作率。
[Translation] Primary objective:
To evaluate the effect of anifrolumab compared with placebo on disease activity based on the difference in the proportion of subjects achieving a BICLA response at week 52.
Key secondary objectives:
To evaluate the effect of anifrolumab compared with placebo on the following indicators:
The proportion of subjects who achieved an OCS dose ≤ 7.5 mg/day at week 40 and maintained it until week 52 in the subgroup of subjects with baseline OCS ≥ 10 mg/day;
The proportion of subjects who achieved a ≥ 50% reduction in the Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) activity score at week 12 in the subgroup of subjects with baseline CLASI activity score ≥ 10;
Annualized flare rate within 52 weeks.