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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06422884
Registration number
NCT06422884
Ethics application status
Date submitted
15/05/2024
Date registered
21/05/2024
Date last updated
15/06/2025
Titles & IDs
Public title
A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
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Scientific title
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)
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Secondary ID [1]
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ENV-IPF-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Progressive Fibrosing Interstitial Lung Disease
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ENV-101
Treatment: Drugs - Placebo
Experimental: ENV-101 Low Dose (IPF Population) -
Experimental: ENV-101 Mid Dose (IPF Population) -
Experimental: ENV-101 High Dose (IPF Population) -
Placebo comparator: Placebo (IPF Population) -
Treatment: Drugs: ENV-101
oral tablet, dosed once a day
Treatment: Drugs: Placebo
oral tablet, dosed once a day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Rate of change in percent predicted forced vital capacity (ppFVC) compared to placebo
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Assessment method [1]
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ppFVC is a measure of lung function
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [1]
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Absolute change in FVC (mL) compared to placebo
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Assessment method [1]
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FVC is a measure of lung function
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Timepoint [1]
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Baseline and Week 24
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Secondary outcome [2]
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Time to disease progression (absolute decline in ppFVC >10%, IPF-related hospitalization, or death) compared to placebo
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Assessment method [2]
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Timepoint [2]
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Baseline and Week 24
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Secondary outcome [3]
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Absolute change in the Living with Pulmonary Fibrosis Symptoms (L-PF Symptoms) Questionnaire Cough domain score compared to placebo
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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Absolute change in the L-PF Symptoms Questionnaire Dyspnea domain score compared to placebo
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline and Week 24
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Secondary outcome [5]
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Absolute change in the L-PF Symptoms Questionnaire Fatigue domain score compared to placebo
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 24
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Secondary outcome [6]
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Absolute change in total lung capacity (TLC) by chest high-resolution computed tomography (HRCT) imaging compared to placebo
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and Week 24
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Secondary outcome [7]
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Absolute change in % quantitative interstitial lung disease (QILD) by chest HRCT imaging compared to placebo compared to placebo
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Assessment method [7]
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Timepoint [7]
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Baseline and Week 24
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Secondary outcome [8]
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Absolute change in % quantitative ground glass opacity (QGG) by chest HRCT imaging compared to placebo
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Assessment method [8]
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Timepoint [8]
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Baseline and Week 24
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Secondary outcome [9]
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Absolute change in % quantitative lung fibrosis (QLF) by chest HRCT imaging compared to placebo
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Assessment method [9]
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Timepoint [9]
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Baseline and Week 24
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2026
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Macquarie Park
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Recruitment hospital [3]
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Research Site - Brisbane
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Recruitment hospital [4]
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Research Site - South Brisbane
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Research Site - Adelaide
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Recruitment hospital [6]
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Research Site - Box Hill
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Recruitment hospital [7]
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Research Site - Melbourne
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Recruitment hospital [8]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2109 - Macquarie Park
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Recruitment postcode(s) [3]
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4032 - Brisbane
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3004 - Melbourne
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Austria
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Steiermark
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Austria
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Vienna
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Belgium
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Namur
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Belgium
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Brussels
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Angers
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France
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Bordeaux
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Caen
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Dijon
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Nantes
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France
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Rennes
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France
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Tours
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Germany
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Hessen
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Germany
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Leipzig
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Queretaro
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Chihuahua
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Mexico City
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Mexico
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Oaxaca
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Mexico
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Puebla
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Auckland
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Christchurch
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New Zealand
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Hamilton
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Birmingham
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Cambridge
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Edinburgh
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Exeter
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Leicester
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Londonderry
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Endeavor Biomedicines, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06422884
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lisa Lancaster, M.D.
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Address
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Endeavor Biomedicines
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Endeavor Clinical Trials
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Address
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Phone
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1-858-727-3199
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06422884
Download to PDF