NCT07805785尚未招募3 期
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel Group Study of Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Progressive Pulmonary Fibrosis (PPF)-PALM-PPF
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 800
- 主要终点
- Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
研究概览
简要总结
The primary objective of this study is to evaluate the effect of 52 weeks of once daily treatment with TPIP compared with placebo on lung function in adults with PPF.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologic evidence of pulmonary fibrosis of >10% extent on high-resolution computed tomography (HRCT) in the previous 12 months.
- •Diagnosis of interstitial lung disease (ILD) (other than idiopathic pulmonary fibrosis [IPF]) that fulfills at least 1 of the following criteria for progression within 24 months of screening despite standard treatment of ILD, as assessed by the Investigator:
- •Clinically significant decline in % predicted Forced Vital Capacity (FVC) based on ≥10% relative decline
- •Decline in % predicted FVC based on ≥5% to <10% relative decline combined with worsening of respiratory symptoms
- •Decline in % predicted FVC based on ≥5% to <10% relative decline combined with an increasing extent of fibrotic changes on chest imaging
- •Worsening of respiratory symptoms and increasing extent of fibrotic changes on chest imaging
- •Forced Vital Capacity ≥45% predicted at Screening.
- •Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin at Screening.
- •Participants may be either:
- •On stable therapy (defined as no dose changes in the prior 12 weeks) with an approved antifibrotic agent (eg, nintedanib or nerandomilast) for at least 12 weeks prior to Screening and during the screening period and are planning to stay on this background treatment throughout the study. Combination therapy with more than 1 approved antifibrotic agent is not allowed. Or
- •Not on treatment with an approved antifibrotic agent (eg, nintedanib or nerandomilast) for at least 8 weeks prior to Screening and during the screening period (ie, either antifibrotic-treatment-naïve or previously discontinued) and do not plan to start or restart antifibrotic treatment during the study.
- •If treated with rituximab, must be on it for at least 6 months before Screening and in the Investigator's clinical opinion must be refractory to the current regimen. If treated with other immunosuppressive agents (eg, mycophenolate, methotrexate, azathioprine, oral corticosteroids), need to be on treatment for at least 12 weeks before Screening and in the investigator's clinical opinion must be refractory to the current regimen.
排除标准
- •Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) <0.7 and less than the age-adjusted lower limit of normal at Screening.
- •Diagnosis of idiopathic pulmonary fibrosis (IPF).
- •Diagnosis of combined pulmonary fibrosis and emphysema.
- •Extent of emphysema greater than fibrosis on HRCT within 1 year prior to Screening or during the screening period confirmed by central overread.
- •Acute ILD exacerbation within 90 days prior to Screening or during the screening period (investigator-determined). If hospitalized for a respiratory indication, participants must have been discharged more than 90 days prior to Screening to be eligible.
- •Acute respiratory infection (eg, COVID-19, influenza, pneumonia) within 30 days prior to Screening or during the Screening period.
- •Acute pulmonary embolism within 90 days prior to Screening.
- •Prior TPIP exposure or participation in other clinical trials involving the study drug, TPIP.
- •Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).
- •History of clinically significant pulmonary hypertension (PH) (ie, pulmonary hypertension requiring medical treatment) or the participant has received any PH-approved therapy, including prostacyclin analogs (eg, beraprost, epoprostenol, iloprost, or treprostinil; except for acute vasoreactivity testing), prostacyclin receptor (IP receptor) agonists (eg, selexipag), endothelin receptor antagonists (eg, ambrisentan, bosentan, or macitentan), activin signaling inhibitors (eg, sotatercept), phosphodiesterase type 5 inhibitors (PDE5-Is; eg, sildenafil, tadalafil), or soluble guanylate cyclase stimulators (eg, riociguat) within 60 days prior to Screening or during the screening period. As needed use of a PDE5-I for erectile dysfunction is permitted, provided that no doses are taken within 48 hours prior to any study-related efficacy assessments.
- •Any physical limitation that would impair the participant's use of the inhaler device or ability to participate in spirometry and/or DLCO assessment.
- •Note: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive a TPIP-matching placebo, QD for up to 104 weeks.
干预措施: Placebo (Drug)
Treprostinil Palmitil Inhalation Powder (TPIP)
Experimental
Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to the maximum tolerated dose (up to 1280 μg) for up to 104 weeks.
干预措施: Treprostinil Palmitil Inhalation Powder (Drug)
结局指标
主要结局
Change From Baseline in Absolute Forced Vital Capacity (FVC) at Week 52
时间窗: Baseline, Week 52
次要结局
- Time to First Clinical Worsening Event(Up to 104 weeks)
- Time to First Acute Exacerbation of Interstitial Lung Disease (ILD)(Up to 104 weeks)
- Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % Predicted Corrected for Hemoglobin at Week 52(Baseline, Week 52)
- Time to Death(Up to 104 weeks)
- Change in Living With Pulmonary Fibrosis (L-PF) Total Symptom Domain Score From Baseline at Week 52(Baseline, Week 52)
- Plasma Concentrations of Treprostinil Palmitil (TP) and Treprostinil (TRE)(Pre-dose and post-dose at multiple timepoints up to Week 52)
- Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)(Up to 104 weeks)
研究者
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