A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 20
- 主要终点
- Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
研究概览
简要总结
A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.
详细描述
Four part study:
Part A - 4 week treatment period evaluating PLN-74809 or matching placebo
Part B - 12 week treatment period evaluating PLN-74809 or matching placebo
Part C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo
Part D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo
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
- •Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C & D)
- •FVC % of predicted ≥45%
- •DLco (hemoglobin-adjusted) ≥30%
- •Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed, 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
Placebo
Placebo
干预措施: Placebo (Drug)
PLN-74809 Dose Level 1 (Part A)
PLN-74809 Dose Level 1 (Part A) - 4 weeks
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 2 (Part A)
PLN-74809 Dose Level 2 (Part A) - 4 weeks
干预措施: PLN-74809 (Drug)
PLN-74809 Dose Level 2 (Part B)
PLN-74809 Dose Level 2 (Part B) - 12 weeks
干预措施: PLN-74809 (Drug)
PLN-74809 - Dose Level 3 (Part C)
PLN-74809 Dose Level 3 (Part C) - 12 weeks
干预措施: PLN-74809 (Drug)
PLN-74809 - Dose Level 4 (Part C)
PLN-74809 Dose Level 4 (Part C) - 12 weeks
干预措施: PLN-74809 (Drug)
PLN-74809 - Dose Level 5 (Part D)
PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks
干预措施: PLN-74809 (Drug)
结局指标
主要结局
Part A - Number of Participants With Serious Treatment-Emergent Adverse Events
时间窗: Up to 4 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Part A - Number of Participants With Treatment-Emergent Adverse Events
时间窗: Up to 4 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events
时间窗: Up to 12 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Part D - Number of Participants With Treatment-Emergent Adverse Events
时间窗: Up to 48 weeks
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.
Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events
时间窗: Up to 12 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Part D - Number of Participants With Serious Treatment-Emergent Adverse Events
时间窗: Up to 48 weeks
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
次要结局
- Part D - Assessment of PLN-74809 Total Plasma Concentrations(Week 24, 2 Hours Post Dose)
- Part A - Assessment of PLN-74809 Total Plasma Concentrations(Week 4, 1 Hour Post Dose)
- Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations(Week 12, 2 Hours Post Dose)