A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 544
- 试验地点
- 174
- 主要终点
- Progression Free Survival
研究概览
简要总结
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects from 45 to 85 years of age
- •Definite IPF within 3 years prior to screening
- •Be able to walk at least 50 meters
排除标准
- •Significant diseases other than IPF
- •Obstructive lung disease
- •Aortic aneurysm greater than or equal to 3.5 cm in diameter
- •Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.
- •N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
- •Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
- •Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Simtuzumab
Participants will receive simtuzumab for up to 254 weeks.
干预措施: Simtuzumab (Drug)
Simtuzumab Placebo
Participants will receive simtuzumab placebo for up to 254 weeks.
干预措施: Simtuzumab placebo (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Up to 148 weeks
Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
PFS Among the Participants With sLOXL2 ≥ 50th Percentile
时间窗: Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 75th Percentile
时间窗: Up to 148 weeks
次要结局
- Overall Survival (OS)(Up to 151 weeks)
- Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile(Up to 151 weeks)
- Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile(Up to 151 weeks)
- Relative Change From Baseline in FVC % Predicted(Weeks 54, 106, and 130)
- Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations(Up to 148 weeks)
- Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations(Up to 148 weeks)
- Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death(Up to 148 weeks)
- Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)(Weeks 58, 106, and 130)
- Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score(Week 58, 106, and 130)