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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

Titles & IDs
Public title
A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial)
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)
Secondary ID [1] 0 0
ENV-IPF-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Progressive Pulmonary Fibrosis 0 0
Progressive Fibrosing Interstitial Lung Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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) -

Experimental: ENV-101 Low Dose (PPF Population) -

Experimental: ENV-101 Mid Dose (PPF Population) -

Experimental: ENV-101 High Dose (PPF Population) -

Placebo comparator: Placebo (PPF Population) -


Treatment: Drugs: ENV-101
oral tablet, dosed once a day

Treatment: Drugs: Placebo
oral tablet, dosed once a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
IPF Population Primary Endpoint: Rate of change in percent predicted forced vital capacity (ppFVC) compared to placebo
Timepoint [1] 0 0
Baseline and Week 24
Primary outcome [2] 0 0
PPF Population Primary Endpoint: Safety
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [1] 0 0
PPF Population: Rate of change in ppFVC compared to placebo
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Absolute change in FVC (mL) compared to placebo
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Time to disease progression (absolute decline in ppFVC >10%, IPF-related hospitalization, or death) compared to placebo
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Absolute change in the Living with Pulmonary Fibrosis Symptoms (L-PF Symptoms) Questionnaire Cough domain score compared to placebo
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Absolute change in the L-PF Symptoms Questionnaire Dyspnea domain score compared to placebo
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Absolute change in the L-PF Symptoms Questionnaire Fatigue domain score compared to placebo
Timepoint [6] 0 0
Baseline and Week 24
Secondary outcome [7] 0 0
Absolute change in total lung capacity (TLC) by chest high-resolution computed tomography (HRCT) imaging compared to placebo
Timepoint [7] 0 0
Baseline and Week 24
Secondary outcome [8] 0 0
Absolute change in % quantitative interstitial lung disease (QILD) by chest HRCT imaging compared to placebo compared to placebo
Timepoint [8] 0 0
Baseline and Week 24
Secondary outcome [9] 0 0
Absolute change in % quantitative ground glass opacity (QGG) by chest HRCT imaging compared to placebo
Timepoint [9] 0 0
Baseline and Week 24
Secondary outcome [10] 0 0
Absolute change in % quantitative lung fibrosis (QLF) by chest HRCT imaging compared to placebo
Timepoint [10] 0 0
Baseline and Week 24

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Research Site - South Brisbane
Recruitment hospital [2] 0 0
Research Site - Adelaide
Recruitment hospital [3] 0 0
Research Site - Box Hill
Recruitment hospital [4] 0 0
Research Site - Melbourne
Recruitment hospital [5] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Austria
State/province [10] 0 0
Vienna
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Germany
State/province [13] 0 0
Munich
Country [14] 0 0
Ireland
State/province [14] 0 0
Dublin
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
(Dong District)
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
(Gangnam District)
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
(Haeundae District)
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
(Seongbuk District)
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
(Songpa District)
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
(Yongsan District)
Country [21] 0 0
Malaysia
State/province [21] 0 0
Kuala Lumpur
Country [22] 0 0
Malaysia
State/province [22] 0 0
Selayang Baru Utara
Country [23] 0 0
Mexico
State/province [23] 0 0
Nuevo Leon
Country [24] 0 0
Mexico
State/province [24] 0 0
Queretaro
Country [25] 0 0
Mexico
State/province [25] 0 0
Chihuahua
Country [26] 0 0
Mexico
State/province [26] 0 0
Mexico City
Country [27] 0 0
Mexico
State/province [27] 0 0
Oaxaca
Country [28] 0 0
Mexico
State/province [28] 0 0
Puebla
Country [29] 0 0
Switzerland
State/province [29] 0 0
Bern
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Edinburgh
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Exeter
Country [32] 0 0
United Kingdom
State/province [32] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Endeavor Biomedicines, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Frohna, M.D., Ph.D., Pharm.D.
Address 0 0
Endeavor Biomedicines
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Endeavor Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
1-858-727-3199
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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