[Translation] A Phase II/III, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of subcutaneous belimumab in adult patients with systemic sclerosis-related interstitial lung disease (SSc-ILD)
主要目的:评价贝利尤单抗与安慰剂相比在标准治疗基础上对减缓DCSSC-ILD受试者肺容量下降的有效性
关键次要目的:
评价贝利尤单抗与安慰剂相比在标准治疗基础上对降低DCSSC-ILD受试者第52周皮肤增厚程度的有效性
评价贝利尤单抗与安慰剂相比在标准治疗基础上减轻DCSSC-ILD受试者疲劳的有效性。
评价贝利尤单抗与安慰剂相比在标准治疗基础上对减缓DCSSC-ILD受试者SSC进展或降低死亡率的有效性
[Translation] Primary objective: To evaluate the effectiveness of belimumab compared with placebo on standard treatment in slowing the decline of lung volume in DCSSC-ILD subjects
Key secondary objectives:
To evaluate the effectiveness of belimumab compared with placebo on standard treatment in reducing the degree of skin thickening at week 52 in DCSSC-ILD subjects
To evaluate the effectiveness of belimumab compared with placebo on standard treatment in reducing fatigue in DCSSC-ILD subjects.
To evaluate the effectiveness of belimumab compared with placebo on standard treatment in slowing the progression of SSC or reducing mortality in DCSSC-ILD subjects