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A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
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) and progressive pulmonary fibrosis (PPF). Another goal of this study is to better understand the safety and tolerability of ENV-101 in these patient populations.
Study details:
This trial is a 6-month, randomized, double-blind, controlled, dose-ranging trial of ENV-101 in two parallel cohorts of adult patients with lung fibrosis: idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). 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 in each indication.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-09-01
Primary completion: 2026-06-01
Study completion finish: 2026-06-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT06422884
Intervention or treatment
DRUG: ENV-101
DRUG: Placebo
Conditions
- • Idiopathic Pulmonary Fibrosis
- • Progressive Pulmonary Fibrosis
- • Progressive Fibrosing Interstitial Lung Disease
Find a site
Closest Location:
Research Site
Research sites nearby
Select from list below to view details:
Research Site
South Brisbane, Queensland, Australia
Research Site
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ENV-101 Low Dose (IPF Population)
| DRUG: ENV-101
|
EXPERIMENTAL: ENV-101 Mid Dose (IPF Population)
| DRUG: ENV-101
|
EXPERIMENTAL: ENV-101 High Dose (IPF Population)
| DRUG: ENV-101
|
PLACEBO_COMPARATOR: Placebo (IPF Population)
| DRUG: Placebo
|
EXPERIMENTAL: ENV-101 Low Dose (PPF Population)
| DRUG: ENV-101
|
EXPERIMENTAL: ENV-101 Mid Dose (PPF Population)
| DRUG: ENV-101
|
EXPERIMENTAL: ENV-101 High Dose (PPF Population)
| DRUG: ENV-101
|
PLACEBO_COMPARATOR: Placebo (PPF Population)
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
IPF Population Primary Endpoint: Rate of change in percent predicted forced vital capacity (ppFVC) compared to placebo | ppFVC is a measure of lung function | Baseline and Week 24 |
PPF Population Primary Endpoint: Safety | The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), and treatment-emergent and clinically significant changes in lab parameters, vital signs, electrocardiogram (ECG), and oxygen saturation | Baseline and Week 24 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
PPF Population: Rate of change in ppFVC compared to placebo | Not Specified | Baseline and Week 24 |
Absolute change in FVC (mL) compared to placebo | FVC is a measure of lung function | Baseline and Week 24 |
Time to disease progression (absolute decline in ppFVC >10%, IPF-related hospitalization, or death) compared to placebo | Not Specified | Baseline and Week 24 |
Absolute change in the Living with Pulmonary Fibrosis Symptoms (L-PF Symptoms) Questionnaire Cough domain score compared to placebo | The L-PF Symptoms Questionnaire Cough domain consists of 6 questions regarding a subject's experience with cough over the prior 24 hours. Questions have response options on a five-point numeric rating scale with an anchor of 0 ("Not at all") to 4 ("Extremely"). Total score for the Cough domain is normalized to the range 0 to 100, with higher scores indicating greater impairment. | Baseline and Week 24 |
Absolute change in the L-PF Symptoms Questionnaire Dyspnea domain score compared to placebo | The L-PF Symptoms Questionnaire Dyspnea domain consists of 12 questions regarding a subject's experience with dyspnea (shortness of breath) over the prior 24 hours. Questions have response options on a five-point numeric rating scale with an anchor of 0 ("Not at all") to 4 ("Extremely"). Total score for the Dyspnea domain is normalized to the range 0 to 100, with higher scores indicating greater impairment. | Baseline and Week 24 |
Absolute change in the L-PF Symptoms Questionnaire Fatigue domain score compared to placebo | The L-PF Symptoms Questionnaire Fatigue domain consists of 5 questions regarding a subject's experience with fatigue over the prior 24 hours. Questions have response options on a five-point numeric rating scale with an anchor of 0 ("Not at all") to 4 ("Extremely"). Total score for the Fatigue domain is normalized to the range 0 to 100, with higher scores indicating greater impairment. | Baseline and Week 24 |
Absolute change in total lung capacity (TLC) by chest high-resolution computed tomography (HRCT) imaging compared to placebo | HRCT is a method of imaging which is more precise than chest x-ray in the diagnosis and monitoring of diseases of the lung tissue and the airways. | Baseline and Week 24 |
Absolute change in % quantitative interstitial lung disease (QILD) by chest HRCT imaging compared to placebo compared to placebo | Not Specified | Baseline and Week 24 |
Absolute change in % quantitative ground glass opacity (QGG) by chest HRCT imaging compared to placebo | Not Specified | Baseline and Week 24 |
Absolute change in % quantitative lung fibrosis (QLF) by chest HRCT imaging compared to placebo | Not Specified | Baseline and Week 24 |
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