A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- PureTech
- 入组人数
- 240
- 试验地点
- 103
- 主要终点
- Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
研究概览
简要总结
This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.
详细描述
This study is a randomized, double-blind, being conducted at centers globally to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in 240 treatment naïve adult patients with IPF ≥ 40 years in age. Patients will be randomized in a ratio of 1:1:1:1 to receive treatment of LYT-100, pirfenidone, or placebo to be taken daily for up to 183 days (26 week treatment period) with the primary outcome of Rate of decline in Forced Vital Capacity (FVC; in mL) over 26 weeks. Secondary endpoints, including spirometry, inflammatory biomarkers, and patient-reported outcomes will also be evaluated.
After completion of the double-blind period of the study, patients may participate in a long-term extension to evaluate tolerability and long-term safety. Patients receiving LYT-100 in the double-blind period will continue the dose throughout the long-term extension. Patients receiving pirfenidone or placebo in the double-blind period will be re-randomized in a 1:1 ratio to receive LYT-100 550mg or 825mg TID dose throughout the long-term extension.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naïve patients or those with <6 months of exposure to nintedanib with physician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines
- •Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 as confirmed by central readers
- •DLCO corrected for Hemoglobin (Hb) [visit 1] ≥ 30% and ≤90% of predicted of normal
- •FVC ≥ 45% of predicted normal
排除标准
- •Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1)
- •Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, and cancer
- •Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis
- •Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion)
- •Cardiovascular diseases, any of the following:
- •Uncontrolled hypertension, within 3 months of Visit 1
- •Myocardial infarction within 6 months of Visit 1
- •Unstable cardiac angina within 6 months of Visit 1
- •Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lower respiratory tract infection within 3-months of Visit 1
研究组 & 干预措施
Placebo
Placebo oral administration
干预措施: Placebo (Drug)
pirfenidone 801 mg TID
pirfenidone 801 mg TID oral administration
干预措施: Pirfenidone (Drug)
LYT-100 550 mg TID
LYT-100 (Deupirfenidone) 550 mg TID oral administration
干预措施: Deupirfenidone (Drug)
LYT-100 825 mg TID
LYT-100 (Deupirfenidone) 825 mg TID oral administration
干预措施: Deupirfenidone (Drug)
结局指标
主要结局
Rate of decline in Forced Vital Capacity over 26 weeks (Part A)
时间窗: 26 weeks
Rate of decline in Forced Vital Capacity (FVC; in mL)
次要结局
- Forced Vital Capacity (FVC) percent predicted change (Part A)(Baseline to Week 26)
- Time to hospitalization or mortality (Part A)(26 weeks)
- Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part A)(26 weeks)
- Forced Vital Capacity (FVC) percent predicted change (Part B)(26 Weeks)
- Rate of decline in Forced Vital Capacity over 26 weeks (Part B)(26 Weeks)
- Time to Idiopathic Pulmonary Fibrosis (IPF) progression (Part B)(26 Weeks)