A Participant- and Investigator-blinded, Randomized, Placebo-controlled, Multicenter, Platform Study to Investigate Efficacy, Safety, and Tolerability of Various Single Treatments in Participants With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 18
- 主要终点
- Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted
研究概览
简要总结
A participant- and investigator-blinded, randomized, placebo-controlled, multicenter, platform study to investigate efficacy, safety, and tolerability of various single treatments in participants with idiopathic pulmonary fibrosis
详细描述
This was a randomized, placebo-controlled, participant- and investigator-blinded platform study in participants with idiopathic pulmonary fibrosis. Participants underwent a screening period of 42 days, a treatment period of 26 weeks and a post-treatment safety follow-up period of 30 days. This study was designed to safely allow rapid and efficient screening of potentially efficacious investigational products in participants with IPF. The study was terminated for strategic reasons and no additional cohorts were created.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants at least 40 years of age
- •IPF diagnosed based on ATS/ERS/JRS/ALAT IPF 2018 modified guidelines
- •FVC ≥45% predicted
- •DLCO, corrected for hemoglobin, ≥25% predicted (inclusive)
- •Unlikely to undergo lung transplantation during this trial in the opinion of the investigator
- •If a participant is taking nintedanib or pirfenidone, they must be on a stable regimen for at least 8 weeks prior to randomization
排除标准
- •Airway obstruction (i.e. prebronchodilator FEV1/ FVC < 0.7) or evidence of a bronchodilator response at screening
- •Emphysema >20% on screening HRCT
- •Fibrosis <10% on screening HRCT
- •Clinical diagnosis of any connective tissue disease
- •Clinically diagnosed acute exacerbation of IPF (AE-IPF) or other significant clinical worsening within 3 months of randomization
- •Additional protocol-defined inclusion / exclusion criteria may apply.
研究组 & 干预措施
LTP001
LTP001 orally once daily in the morning for approximately 26 weeks.
干预措施: LTP001 (Drug)
LTP001
LTP001 orally once daily in the morning for approximately 26 weeks.
干预措施: Standard of Care (SoC) (Drug)
Placebo
Placebo orally once daily in the morning for approximately 26 weeks.
干预措施: Placebo (Drug)
Placebo
Placebo orally once daily in the morning for approximately 26 weeks.
干预措施: Standard of Care (SoC) (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment Epoch in Forced Vital Capacity (FVC) Expressed in Percent Predicted
时间窗: Baseline, up to approximately 26 weeks
Forced Vital Capacity (FVC) is the total amount of air exhaled during the Forced expiratory volume (FEV) test measured through spirometry testing. FEV measures how much air a person can exhale during a forced breath. It is expressed as percent predicted, defined as FVC of the participant divided by the average FVC in the population for any person of similar age, sex, and body composition multiplied by 100. A positive change from baseline is considered a favorable outcome.
次要结局
- Change From Baseline to End of Treatment Epoch in FVC(Baseline, up to approximately 26 weeks)
- Progression-free Survival (PFS)(Baseline, up to approximately 26 weeks)
- Number of Participants With Absolute Decline of ≥10% Predicted in FVC(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Diffusion Capacity of Lung for Carbon Monoxide (DLCO)(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in 6-minute Walk Distance (6MWD)(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Total Score From the K-BILD Questionnaire(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Scores From Leicester Cough Questionnaire(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Scores From the the R-Scale for IPF Questionnaire(Baseline, up to approximately 26 weeks)
- Change From Baseline to the End of Treatment Epoch in Total Score From the Living With IPF Questionnaire(Baseline, up to approximately 26 weeks)