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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Endeavor Biomedicines Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 May 2025 → ongoing

Decision date (initial)

2025-03-10

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Endeavor BioMedicines Inc.

External identifiers

EU CT number

2024-511754-41-00

ClinicalTrials.gov

NCT06422884

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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

Secondary objectives 3

1. To characterize the safety of ENV-101 in patients with IPF.
2. To characterize the effects of ENV-101 on patient reported outcomes in patients with IPF.
3. To characterize the effects of ENV-101 on lung capacity and lung fibrosis as measured by chest HRCT in patients with IPF.

Conditions and MedDRA coding

idiopathic pulmonary fibrosis

Regulatory references

Scientific advice from competent authorities

Medicines And Healthcare Products Regulatory Agency, Food And Drug Administration

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 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 during Screening or within 30 days prior to Screening must be consistent with the diagnosis of IPF, as confirmed by central read/review.
2. Percent predicted FVC of ≥ 45% at the Screening Visit.
3. Percent predicted DLCO ≥ 25%, adjusted for hemoglobin (Hgb) at the Screening Visit.
4. Ability to perform spirometry tests.
5. 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 5

1. Evidence of other known causes of interstitial lung disease [e.g., domestic and occupational environmental exposures and drug toxicity].
2. Lung transplant expected within 12 months of the Screening Visit.
3. 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.
4. Forced expiratory volume in one second (FEV1)/FVC ratio <0.7 at the Screening Visit.
5. Acute exacerbation of IPF, in the opinion of the Investigator, within 3 months prior to Day 1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in ppFVC from baseline to Week 24, as compared to PBO.

Secondary endpoints 5

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Endeavor Biomedicines Inc.

Sponsor organisation

Endeavor Biomedicines Inc.

Address

12707 High Bluff Drive Suite 300

City

San Diego

Postcode

92130-3045

Country

United States

Scientific contact point

Organisation

Endeavor Biomedicines Inc.

Contact name

Miguel de los Rios

Public contact point

Organisation

Endeavor Biomedicines Inc.

Contact name

-

Third parties 10

Locations

6 EU/EEA countries · 31 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 41 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications