BridgeMD
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)
EU CTIS ID: 2024-511754-41-00
What this study is testing
To characterize the efficacy of a range of doses of ENV-101 in patients with IPF at 24 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Korea, Republic of
- United States
- Canada
- Argentina
- Malaysia
- New Zealand
- Mexico
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Korea, Republic of; United States; Canada; Argentina; Malaysia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.