[Translation] A randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the efficacy and safety of PLN-74809 (Bexotegrast) in the treatment of idiopathic pulmonary fibrosis (BEACON-IPF)
主要目的:表征第52周时bexotegrast相比安慰剂对特发性肺纤维化( IPF)受试者的用力肺活量(FVC)变化的影响。次要目的:1.表征52周治疗期间 bexotegrast相比安慰剂对疾病进展的影响。2.在基线接受和未接受背景治疗的IPF受试者中,表征第52周时bexotegrast相比安慰剂对FVC变化的影响。3.表征52周治疗后 bexotegrast相比安慰剂对IPF总体症状和功能改善的影响。4.利用高分辨率计算机断层扫描(HRCT),表征第52周时bexotegrast相比安慰剂对肺纤维化改变的影响。5.表征52周治疗期间 bexotegrast相比安慰剂在 IPF受试者中的安全性和耐受性。
[Translation] Primary Objectives: To characterize the effect of bexotegrast versus placebo on the change in forced vital capacity (FVC) at week 52 in subjects with idiopathic pulmonary fibrosis (IPF). Secondary Objectives: 1. To characterize the effect of bexotegrast versus placebo on disease progression during the 52-week treatment period. 2. To characterize the effect of bexotegrast versus placebo on the change in FVC at week 52 in subjects with IPF who did and did not receive background therapy at baseline. 3. To characterize the effect of bexotegrast versus placebo on improvement in global symptoms and function in IPF after 52 weeks of treatment. 4. To characterize the effect of bexotegrast versus placebo on changes in lung fibrosis at week 52 using high-resolution computed tomography (HRCT). 5. To characterize the safety and tolerability of bexotegrast versus placebo in subjects with IPF during the 52-week treatment period.