NCT06422884进行中（未招募）2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Controlled Trial Evaluating the Safety and Efficacy of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 213
- 试验地点
- 79
- 主要终点
- Change in percent predicted forced vital capacity (ppFVC) compared to placebo
研究概览
简要总结
The goal of this clinical trial is to evaluate the impact that ENV-101 has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in this patient population.
详细描述
This trial is a 6-month, randomized, double-blind, controlled, dose-ranging trial of ENV-101 in adult patients with idiopathic pulmonary fibrosis (IPF). Patients are allowed to continue treatment with approved standard of care (e.g., nintedanib, pirfenidone) during the trial. Patients will be randomized to one of 3 dose levels of ENV-101 or placebo at baseline. The objectives of this trial are to characterize the efficacy, antifibrotic activity, and safety of ENV-101 to select the Phase 3 dose of ENV-101.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65+ years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 40 years old with an IPF diagnosis as confirmed by the Investigator.
- •Percent predicted FVC of ≥ 45% at study start.
- •Percent predicted diffusing capacity of lung for carbon monoxide (DLCO) ≥ 25%, adjusted for hemoglobin (Hgb) at study start.
- •Ability to perform spirometry tests.
- •Either stable treatment with standard of care (SoC) [i.e., antifibrotics, immunosuppressants (PPF only)] for at least 3 months prior to study start or not treated with SoC for at least 8 weeks prior to study start.
排除标准
- •Evidence of other known causes of interstitial lung disease (ILD).
- •Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at study start.
- •History of malignancy, including carcinoma during the preceding 5 years from study start, with the following exceptions:
- •Prior history of in situ melanoma, basal or squamous cell skin cancer if treated with curative therapy.
- •Patients with prostate cancer that are managed by surveillance.
- •Patients with ductal carcinoma in situ, treated surgically with curative intent.
- •Patients with moderate to severe hepatic impairment (Child-Pugh B and C).
- •Smoking (including vaping) within 6 months of study start; current smoker, or unwillingness to refrain from smoking during the clinical trial duration.
- •Active or suspected alcohol or drug abuse in the opinion of the Investigator.
- •Currently enrolled in another investigational device or drug trial, or less than 3 months from study start since ending another investigational device or drug trial(s) or receiving other investigational treatment(s).
- •Presence of active infection at study start or confirmed active human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
- •Major surgery requiring hospitalization (according to the Investigator) performed within 3 months prior to study start or planned during the course of the trial. Being on a transplant list is allowed.
- •Occurrence of serious illness requiring hospitalization within 90 days prior to study start.
- •Current or previous use (within 28 days prior to study start) of the following:
- •Endothelin receptor antagonist
- •Prostacyclin or prostacyclin analogue
- •Radiation to the lungs
- •Oral corticosteroids >15 mg/day
- •Use of cyclophosphamide or tocilizumab within 8 weeks, or rituximab within 6 months, prior to study start.
- •Use of drugs that are known moderate or stronger CYP3A4 inhibitors or inducers within 14 days prior to study start. Patients must also agree not to eat fruits that inhibit CYP3A4 such as grapefruit, Seville oranges, pomelo and star fruit.
- •Patients of reproductive potential who are sexually active and unwilling to use birth control for the duration of the study and for 3 months after their final dose of study drug.
- •Females that are pregnant or nursing.
- •Patients that are unwilling to refrain from blood or blood product donation for the duration of the study and for 30 days after their final dose of study drug.
- •Males who are unwilling to refrain from sperm donation and females who are unwilling to refrain from egg donation for the duration of the study and for 3 months after their final dose of study drug.
- •Patients with a history of a severe allergic reaction or anaphylactic reaction or known hypersensitivity to any component of ENV-
- •Patients who have previously taken ENV-101.
研究组 & 干预措施
ENV-101 Mid Dose (IPF Population)
Experimental
干预措施: ENV-101 (Drug)
Placebo (IPF Population)
Placebo Comparator
干预措施: Placebo (Drug)
ENV-101 High Dose (IPF Population)
Experimental
干预措施: ENV-101 (Drug)
ENV-101 Low Dose (IPF Population)
Experimental
干预措施: ENV-101 (Drug)
结局指标
主要结局
Change in percent predicted forced vital capacity (ppFVC) compared to placebo
时间窗: Baseline and Week 24
ppFVC is a measure of lung function
次要结局
- Absolute change in FVC (mL) compared to placebo(Baseline and Week 24)
- Time to disease progression (absolute decline in ppFVC >10%, IPF-related hospitalization, or death) compared to placebo(Baseline and Week 24)
- Absolute change in the Living with Pulmonary Fibrosis Symptoms (L-PF Symptoms) Questionnaire Cough domain score compared to placebo(Baseline and Week 24)
- Absolute change in the L-PF Symptoms Questionnaire Dyspnea domain score compared to placebo(Baseline and Week 24)
- Absolute change in the L-PF Symptoms Questionnaire Fatigue domain score compared to placebo(Baseline and Week 24)
- Absolute change in the L-PF Symptoms module score compared to placebo(Baseline and Week 24)
- Absolute change in the L-PF Impacts module score compared to placebo(Baseline and Week 24)
- Absolute change in total lung capacity (TLC) by chest high-resolution computed tomography (HRCT) imaging compared to placebo(Baseline and Week 24)
- Absolute change in % quantitative interstitial lung disease (QILD) by chest HRCT imaging compared to placebo compared to placebo(Baseline and Week 24)
- Absolute change in % quantitative ground glass opacity (QGG) by chest HRCT imaging compared to placebo(Baseline and Week 24)
- Absolute change in % quantitative lung fibrosis (QLF) by chest HRCT imaging compared to placebo(Baseline and Week 24)
研究者
Miguel de los Rios
Scientific
Endeavor Biomedicines Inc.
研究点 (79)
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相关资讯
Endeavor BioMedicines Receives Dual Orphan Drug Designation for Taladegib in Idiopathic Pulmonary Fibrosis- Both the FDA and European Commission have granted Orphan Drug Designation to taladegib (ENV-101) for treating idiopathic pulmonary fibrosis, highlighting significant unmet medical need.
- The investigational Hedgehog pathway inhibitor aims to reverse disease progression by stopping abnormal myofibroblast accumulation that causes lung fibrosis.
- Endeavor is currently enrolling patients in the Phase 2b WHISTLE-PF trial, with enrollment expected to complete in 2026.
- IPF affects more than 150,000 adults in the United States with limited treatment options and an average life expectancy of three to five years after diagnosis.last yearENV-101 Shows Promising Results in Idiopathic Pulmonary Fibrosis Treatment, Reducing Pulmonary Vessel Volume- Endeavor BioMedicines' ENV-101 demonstrated significant reduction in pulmonary vessel volume and increase in lung volume in IPF patients during a Phase 2a clinical trial, with results presented at ATS 2025.
- The post-hoc analysis utilized Qureight's deep learning-based CT analytics, showing ENV-101 is the first therapeutic to reduce pulmonary vessel volume in IPF patients, a marker correlated with improved mortality.
- Endeavor has initiated the Phase 2b WHISTLE-PF trial to further evaluate ENV-101's efficacy across multiple doses in IPF, a devastating disease affecting over 150,000 Americans with limited treatment options.last year