[Translation] A phase II/III, randomized, double-blind, placebo-controlled, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous belimumab in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). parallel group study
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 purpose: To evaluate the effectiveness of belimumab compared with placebo in slowing the decline in lung volume in subjects with DCSSC-ILD on the basis of standard treatment.
Key secondary purposes:
To evaluate the effectiveness of belimumab compared with placebo in reducing skin thickening at week 52 in subjects with DCSSC-ILD in addition to standard treatment
To evaluate the effectiveness of belimumab compared with placebo in reducing fatigue in subjects with DCSSC-ILD on the basis of standard treatment.
To evaluate the effectiveness of belimumab compared with placebo in slowing the progression of SSC or reducing mortality in subjects with DCSSC-ILD on the basis of standard treatment.