[Translation] A multicenter, parallel-group, double-blind, two-arm, phase III study evaluating the efficacy and safety of standard therapy plus subcutaneous anifrolumab versus standard therapy plus placebo in adult subjects with idiopathic inflammatory myopathies (polymyositis and dermatomyositis)
主要目的:证明Anifrolumab在第52周疾病活动度中度改善方面相较于安慰剂的优效性
关键次要目的:1. 证明第52周时Anifrolumab在肌肉改善方面相较于安慰剂的优效性
2. 证明第52周时Anifrolumab在OCS剂量下降方面相较于安慰剂的优效性
3. 证明第52周时Anifrolumab在PM受试者疾病活动度中度改善方面相较于安慰剂的优效性
4. 证明第52周时Anifrolumab在DM受试者疾病活动度中度改善方面相较于安慰剂的优效性
5. 证明第8周时Anifrolumab在皮肤疾病活动度改善方面相较于安慰剂的优效性
次要目的:1. 评估Anifrolumab与安慰剂相比在第52周疾病活动度方面的有效性
[Translation] Primary objective: To demonstrate the superiority of Anifrolumab over placebo in moderate improvement of disease activity at week 52
Key secondary objectives: 1. To demonstrate the superiority of Anifrolumab over placebo in muscle improvement at week 52
2. To demonstrate the superiority of Anifrolumab over placebo in OCS dose reduction at week 52
3. To demonstrate the superiority of Anifrolumab over placebo in moderate improvement of disease activity in PM subjects at week 52
4. To demonstrate the superiority of Anifrolumab over placebo in moderate improvement of disease activity in DM subjects at week 52
5. To demonstrate the superiority of Anifrolumab over placebo in improvement of skin disease activity at week 8
Secondary objectives: 1. To evaluate the effectiveness of Anifrolumab compared with placebo in disease activity at week 52