A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Evaluation of PLN-74809 on Type 1 Collagen Deposition Using 68Ga-CBP8 PET/MRI Imaging in Participants With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
This is a Phase 2a, single -center, randomized, double-blind, placebo-controlled study to evaluate type 1 collagen deposition in the lungs following once-daily treatment with PLN-74809 for 12-weeks. This study is occurring at Massachusetts General Hospital.
详细描述
This is a Phase 2a, single-center, randomized, double-blinded, placebo-controlled study to evaluate type 1 collagen deposition in the lungs of participants with Idiopathic Pulmonary Fibrosis (IPF) following once-daily (QD) treatment with 160 mg PLN-74809 for 12 weeks. The study consists of an up to 28-day screening period, a 12-week treatment period, and a 2 week (±3 days) post treatment follow-up period.
Approximately 12 eligible participants will be randomized in a 2:1 ratio (160 mg PLN-74809 vs placebo; approximately 8 receiving PLN-74809 and 4 receiving placebo) on Day 1 (Visit 3). Randomization will be stratified by use of standard of care IPF therapy with pirfenidone or nintedanib. PET/MRI scans will be conducted at Baseline and at Week 12.
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)
盲法说明
double-blind
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
- •Participants, aged 40 years or older
- •Diagnosis of IPF, within 8 years prior to Screening
- •FVC % predicted ≥45%; historical FVC for entry in the study is permitted if within 1 month of screening
- •Diffusing capacity for carbon monoxide DLco (hemoglobin-adjusted) ≥30%; historical DLco for entry in the study is permitted if within 1 month of Screening
- •Participants currently receiving treatment for IPF with nintedanib or pirfenidone are permitted, if on a stable dose for at least 3 months
排除标准
- •Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA
- •Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio <0.7 at Screening
- •Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression
- •Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening
- •Smoking of any kind within 3 months of Screening
研究组 & 干预措施
PLN-74809
160 mg PLN-74809
干预措施: PLN-74809 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Outcome
时间窗: 12 weeks
Change from Baseline in top quartile whole lung PET standardized uptake value (SUV) following 12 weeks of treatment with PLN-74809. The whole lung SUV measures the intensity of the uptake of the radiotracer, 68GA-CBP8: peptide-based collagen binding probe 8 tagged with Gallium-68 radioisotope, in lung tissue. A negative change from baseline is a positive outcome and represents a decrease in the whole lung SUV corresponding to a decrease in collagen deposition in the lung. A positive change from baseline is a negative outcome and represents an increase in the whole lung SUV corresponding to an increase in collagen deposition in the lung.
次要结局
- Secondary Safety and Tolerability(From screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose)