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A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)

PHASE2NOT_YET_RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

IPF Population: Patients ≥ 40 years old with an IPF diagnosis as confirmed by the Investigator.

PPF Population: Patients ≥ 18 years old (or the minimum legal adult age, whichever is greater) with a diagnosis of PPF, 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.

Exclusion criteria

IPF Population: 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: 1. Prior history of in situ melanoma, basal or squamous cell skin cancer if treated with curative therapy. 2. Patients with prostate cancer that are managed by surveillance. 3. 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: 1. Endothelin receptor antagonist 2. Riociguat 3. Prostacyclin or prostacyclin analogue 4. Radiation to the lungs 5. 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-101.

Patients who have previously taken ENV-101.

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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

Image related to Idiopathic Pulmonary Fibrosis

Condition: Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis and more
DRUG: ENV-101 and other drugs
South Brisbane, Queensland, Australia and more
Sponsor: Endeavor Biomedicines, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Research Site

Research sites nearby

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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) Not Specified	DRUG: ENV-101 oral tablet, dosed once a day
EXPERIMENTAL: ENV-101 Mid Dose (IPF Population) Not Specified	DRUG: ENV-101 oral tablet, dosed once a day
EXPERIMENTAL: ENV-101 High Dose (IPF Population) Not Specified	DRUG: ENV-101 oral tablet, dosed once a day
PLACEBO_COMPARATOR: Placebo (IPF Population) Not Specified	DRUG: Placebo oral tablet, dosed once a day
EXPERIMENTAL: ENV-101 Low Dose (PPF Population) Not Specified	DRUG: ENV-101 oral tablet, dosed once a day
EXPERIMENTAL: ENV-101 Mid Dose (PPF Population) Not Specified	DRUG: ENV-101 oral tablet, dosed once a day
EXPERIMENTAL: ENV-101 High Dose (PPF Population) Not Specified	DRUG: ENV-101 oral tablet, dosed once a day
PLACEBO_COMPARATOR: Placebo (PPF Population) Not Specified	DRUG: Placebo oral tablet, dosed once a day

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

Frequently Asked Questions

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References

Clinical Trials Gov: A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)