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)

Phase 2

Recruiting

• Conditions: idiopathic pulmonary fibrosis

• Registration Number: 2024-511754-41-00
• Lead Sponsor: Endeavor Biomedicines Inc.

Brief Summary

To characterize the efficacy of a range of doses of ENV-101 in patients with IPF at 24 weeks.

Detailed Description

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.

Study Timeline

• Study First Posted: 2025-03-03
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

Patients ≥ 40 years old with an IPF diagnosis within the last 5 years based on 2022 international guidelines as confirmed by the Investigator. A qualifying chest HRCT scan taken within 30 days of the Screening Visit must be consistent with the diagnosis of IPF, as confirmed by central read/review.

Percent predicted FVC of ≥ 45% at the Screening Visit.

Percent predicted DLCO ≥ 25%, adjusted for hemoglobin (Hgb) at the Screening Visit.

Ability to perform spirometry tests.

Either stable treatment with SoC (i.e., antifibrotics) for at least 3 months prior to Day 1 or not treated with SoC for at least 8 weeks prior to Day 1.

Exclusion Criteria

Evidence of other known causes of interstitial lung disease [e.g., domestic and occupational environmental exposures and drug toxicity].

Lung transplant expected within 12 months of the Screening Visit.

Evidence of clinically significant lung disease, other than IPF, including but not limited to asthma, chronic obstructive pulmonary disease (COPD), uncontrolled pulmonary hypertension and emphysema where computed tomography (CT)-assessed extent of emphysema is greater than extent of fibrosis, or clinically significant pulmonary abnormalities.

Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at the Screening Visit.

Acute exacerbation of IPF, in the opinion of the Investigator, within 3 months prior to Day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of change in ppFVC from baseline to Week 24, as compared to PBO.		Rate of change in ppFVC from baseline to Week 24, as compared to PBO.

Secondary Outcome Measures

Name	Time	Method
Absolute change in FVC (mL) from baseline to Week 24, as compared to PBO.		Absolute change in FVC (mL) from baseline to Week 24, as compared to PBO.
Time to disease progression (absolute decline in ppFVC >10%, IPF related hospitalization, or death) up to Week 24, as compared to PBO.		Time to disease progression (absolute decline in ppFVC >10%, IPF related hospitalization, or death) up to Week 24, as compared to PBO.
Absolute change in L-PF Symptoms Cough domain score from baseline to Week 24, as compared to PBO.		Absolute change in L-PF Symptoms Cough domain score from baseline to Week 24, as compared to PBO.
Absolute change in L-PF Symptoms Dyspnea domain score from baseline to Week 24, as compared to PBO.		Absolute change in L-PF Symptoms Dyspnea domain score from baseline to Week 24, as compared to PBO.
Absolute change in Living with L-PF Symptoms Fatigue domain score from baseline to Week 24, as compared to PBO		Absolute change in Living with L-PF Symptoms Fatigue domain score from baseline to Week 24, as compared to PBO

Trial Locations

Locations (31)

Medical University Of Vienna; 🇦🇹 Vienna, Austria

Medical University Of Graz; 🇦🇹 Graz, Austria

Cliniques Universitaires Saint-Luc; 🇧🇪 Sint-Lambrechts-Woluwe, Belgium

Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur; 🇧🇪 Yvoir, Belgium

Hopital Erasme; 🇧🇪 Anderlecht, Belgium

Assistance Publique Hopitaux De Paris; 🇫🇷 Le Kremlin-Bicetre, France

Centre Hospitalier Universitaire De Caen Normandie; 🇫🇷 Caen Cedex 9, France

Centre Hospitalier Universitaire De Rennes; 🇫🇷 Rennes Cedex 9, France

GIE Groupe hospitalier Paris Saint-Joseph/Vinci; 🇫🇷 Paris, France

Centre Hospitalier Universitaire De Montpellier; 🇫🇷 Montpellier Cedex 5, France

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Medical University Of Vienna

🇦🇹Vienna, Austria

Marco Idzko

Site contact

+4314040047760

marco.idzko@meduniwien.ac.at