Efficacy and Safety of SAR156597 in the Treatment of Idiopathic Pulmonary Fibrosis (IPF): A Randomized, Double-blind, Placebo-controlled, 52-week Dose-ranging Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 327
- 试验地点
- 101
- 主要终点
- Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
研究概览
简要总结
Primary Objective:
To evaluate, in comparison with placebo, the efficacy of 2 dose levels/regimens of SAR156597 administered subcutaneously during 52 weeks on lung function of participants with Idiopathic Pulmonary Fibrosis (IPF).
Secondary Objectives:
To evaluate the efficacy of 2 dose levels/regimens of SAR156597 compared to placebo on IPF disease progression.
To evaluate the safety of 2 dose levels/regimens of SAR156597 compared to placebo in participants with IPF.
详细描述
The total study duration of study was expected up to 68 weeks (screening period of 4 weeks, treatment period of 52 weeks, and 12 weeks of follow up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo qw
Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks.
干预措施: placebo (Drug)
SAR156597 200 mg q2w
Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
干预措施: SAR156597 (Drug)
SAR156597 200 mg q2w
Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks.
干预措施: placebo (Drug)
SAR156597 200 mg qw
Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks.
干预措施: SAR156597 (Drug)
结局指标
主要结局
Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) at Week 52
时间窗: Baseline, Week 52
FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.
次要结局
- Time to Disease Progression: Kaplan-Meier Estimates of Probability of Disease Progression at Week 52(From randomization to disease progression (up to Week 52))
- Time to Event: Kaplan-Meier Estimates of Probability of All Cause Mortality (Deaths) at Week 52(From randomization up to Week 52)