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

NCT ID: NCT06422884

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis Progressive Fibrosing Interstitial Lung Disease

Keywords

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taladegib hedgehog pathway inhibitor pulmonary fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ENV-101 Low Dose (IPF Population)

Group Type EXPERIMENTAL

ENV-101

Intervention Type DRUG

oral tablet, dosed once a day

ENV-101 Mid Dose (IPF Population)

Group Type EXPERIMENTAL

ENV-101

Intervention Type DRUG

oral tablet, dosed once a day

ENV-101 High Dose (IPF Population)

Group Type EXPERIMENTAL

ENV-101

Intervention Type DRUG

oral tablet, dosed once a day

Placebo (IPF Population)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral tablet, dosed once a day

Interventions

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ENV-101

oral tablet, dosed once a day

Intervention Type DRUG

Placebo

oral tablet, dosed once a day

Intervention Type DRUG

Other Intervention Names

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taladegib

Eligibility Criteria

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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.

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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Endeavor Biomedicines, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa Lancaster, M.D.

Role: STUDY_DIRECTOR

Endeavor Biomedicines

Locations

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Research Site

Quilmes, Buenos Aires, Argentina

Site Status RECRUITING

Research Site

Buenos Aires, , Argentina

Site Status RECRUITING

Research Site

Buenos Aires, , Argentina

Site Status RECRUITING

Research Site

Mendoza, , Argentina

Site Status RECRUITING

Research Site

Mendoza, , Argentina

Site Status RECRUITING

Research Site

Camperdown, New South Wales, Australia

Site Status NOT_YET_RECRUITING

Research Site

Macquarie Park, New South Wales, Australia

Site Status RECRUITING

Research Site

Brisbane, Queensland, Australia

Site Status RECRUITING

Research Site

South Brisbane, Queensland, Australia

Site Status RECRUITING

Research Site

Adelaide, South Australia, Australia

Site Status WITHDRAWN

Research Site

Box Hill, Victoria, Australia

Site Status RECRUITING

Research Site

Melbourne, Victoria, Australia

Site Status WITHDRAWN

Research Site

Nedlands, Western Australia, Australia

Site Status RECRUITING

Research Site

Graz, Styria, Austria

Site Status RECRUITING

Research Site

Vienna, , Austria

Site Status RECRUITING

Research Site

Dinant, Namur, Belgium

Site Status RECRUITING

Research Site

Brussels, , Belgium

Site Status RECRUITING

Research Site

Brussels, , Belgium

Site Status RECRUITING

Research Site

Edmonton, Alberta, Canada

Site Status RECRUITING

Research Site

Vancouver, British Columbia, Canada

Site Status RECRUITING

Research Site

Ajax, Ontario, Canada

Site Status RECRUITING

Research Site

Montreal, Quebec, Canada

Site Status RECRUITING

Research Site

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Research Site

Trois-Rivières, Quebec, Canada

Site Status RECRUITING

Research Site

Angers, , France

Site Status RECRUITING

Research Site

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Research Site

Caen, , France

Site Status NOT_YET_RECRUITING

Research Site

Dijon, , France

Site Status NOT_YET_RECRUITING

Research Site

Montpellier, , France

Site Status RECRUITING

Research Site

Nantes, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status NOT_YET_RECRUITING

Research Site

Rennes, , France

Site Status NOT_YET_RECRUITING

Research Site

Tours, , France

Site Status NOT_YET_RECRUITING

Research Site

Giessen, Hesse, Germany

Site Status RECRUITING

Research Site

Immenhausen, Hesse, Germany

Site Status RECRUITING

Research Site

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Research Site

Essen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Research Site

Berlin, , Germany

Site Status RECRUITING

Research Site

Leipzig, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Dublin, Leinster, Ireland

Site Status RECRUITING

Research Site

Dublin, Leinster, Ireland

Site Status RECRUITING

Research Site

Cork, Munster, Ireland

Site Status RECRUITING

Research Site

Dublin, , Ireland

Site Status RECRUITING

Research Site

Bologna, Forli-Cesena, Italy

Site Status RECRUITING

Research Site

Padua, Padua, Italy

Site Status RECRUITING

Research Site

Florence, Tuscany, Italy

Site Status RECRUITING

Research Site

Catania, , Italy

Site Status RECRUITING

Research Site

Milan, , Italy

Site Status RECRUITING

Research Site

Turin, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Kuala Lumpur, Selangor, Malaysia

Site Status RECRUITING

Research Site

Kuala Lumpur, Selangor, Malaysia

Site Status RECRUITING

Research Site

Kuala Lumpur, Selangor, Malaysia

Site Status RECRUITING

Research Site

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Research Site

Monterrey, Nuevo León, Mexico

Site Status NOT_YET_RECRUITING

Research Site

San Nicolás de los Garza, Nuevo León, Mexico

Site Status RECRUITING

Research Site

San Juan del Río, Querétaro, Mexico

Site Status RECRUITING

Research Site

Chihuahua City, , Mexico

Site Status RECRUITING

Research Site

Mexico City, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Oaxaca City, , Mexico

Site Status RECRUITING

Research Site

Puebla City, , Mexico

Site Status NOT_YET_RECRUITING

Research Site

Auckland, , New Zealand

Site Status RECRUITING

Research Site

Christchurch, , New Zealand

Site Status RECRUITING

Research Site

Hamilton, , New Zealand

Site Status RECRUITING

Research Site

Seoul, (Deogyang District), South Korea

Site Status RECRUITING

Research Site

Ulsan, (Dong District), South Korea

Site Status RECRUITING

Research Site

Seoul, (Gangnam District), South Korea

Site Status WITHDRAWN

Research Site

Busan, (Haeundae District), South Korea

Site Status RECRUITING

Research Site

Seoul, (Seongbuk District), South Korea

Site Status RECRUITING

Research Site

Seoul, (Songpa District), South Korea

Site Status RECRUITING

Research Site

Seoul, (Yongsan District), South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Belfast, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Birmingham, , United Kingdom

Site Status RECRUITING

Research Site

Birmingham, , United Kingdom

Site Status RECRUITING

Research Site

Cambridge, , United Kingdom

Site Status RECRUITING

Research Site

Edinburgh, , United Kingdom

Site Status RECRUITING

Research Site

Exeter, , United Kingdom

Site Status RECRUITING

Research Site

Leicester, , United Kingdom

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

Londonderry, , United Kingdom

Site Status RECRUITING

Countries

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Switzerland United States Argentina Australia Austria Belgium Canada France Germany Ireland Italy Malaysia Mexico New Zealand South Korea United Kingdom

Central Contacts

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Endeavor Clinical Trials

Role: CONTACT

Phone: 1-858-727-3199

Email: [email protected]

Facility Contacts

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Endeavor Clinical Trials

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Other Identifiers

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ENV-IPF-103

Identifier Type: -

Identifier Source: org_study_id