Not recruitingRare disease

Study on the Safety and Effectiveness of Taladegib for Patients with Idiopathic Pulmonary Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a lung disease called idiopathic pulmonary fibrosis (IPF). IPF is a condition where the lungs become scarred and stiff, making it difficult to breathe. The study will test a treatment called Taladegib, also known by its code name ENV-101. Taladegib is taken as a tablet and is being evaluated for its safety and effectiveness in treating IPF.

The purpose of the study is to understand how well different doses of Taladegib work in patients with IPF over a period of 24 weeks. Participants in the study will be randomly assigned to receive either Taladegib or a placebo, which looks like the Taladegib tablet but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medication orally and will be monitored for changes in their lung function and symptoms. The study will last for about six months, during which time the researchers will collect data on how the treatment affects the progression of the disease, including any changes in breathing ability and overall health. The goal is to determine if Taladegib can help slow down or improve the symptoms of IPF compared to the placebo.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a chest scan to confirm the diagnosis of idiopathic pulmonary fibrosis (IPF).
The assessment ensures that the patient is at least 40 years old, has a lung function test result of at least 45% for forced vital capacity (FVC), and a diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 25%.
Step 2
Randomization and treatment allocation
Patients are randomly assigned to receive either the active medication, Taladegib, or a placebo. The study is double-blind, meaning neither the patient nor the study team knows which treatment is being administered.
The active medication is provided in tablet form and is taken orally. The dosage is either 25 mg or 100 mg, depending on the group assignment.
Step 3
Treatment period
The treatment period lasts for 24 weeks. During this time, patients take the assigned medication daily.
Regular follow-up visits are scheduled to monitor health status and any changes in lung function. These visits include spirometry tests to measure lung capacity and other assessments to track symptoms such as cough and breathlessness.
Step 4
End of treatment evaluation
At the end of the 24-week treatment period, a final evaluation is conducted. This includes a comprehensive review of lung function and symptom changes.
The primary goal is to assess the rate of change in lung function from the start to the end of the study. Secondary assessments include changes in symptoms and overall health status.

Who can join the trial?

7 criteria

Patients must be **40 years or older**.
Must have a diagnosis of **idiopathic pulmonary fibrosis (IPF)** within the last 5 years. This is a lung disease that causes scarring of the lungs for an unknown reason.
A **chest HRCT scan** taken within 30 days of the Screening Visit must confirm the IPF diagnosis. HRCT is a special type of scan that gives detailed images of the lungs.
Must have a **percent predicted FVC** of 45% or more at the Screening Visit. FVC stands for Forced Vital Capacity, which measures how much air you can exhale after taking a deep breath.
Must have a **percent predicted DLCO** of 25% or more, adjusted for hemoglobin (Hgb) at the Screening Visit. DLCO measures how well the lungs transfer oxygen into the blood.
Must be able to perform **spirometry tests**, which are simple tests to check lung function.
Must be on stable treatment with **standard of care (SoC)**, such as antifibrotic medications, for at least 3 months before the study starts, or not have been treated with SoC for at least 8 weeks before the study starts.

Who cannot join the trial?

7 criteria

Patients who have a different lung condition other than idiopathic pulmonary fibrosis (IPF) cannot participate. IPF is a disease that causes scarring in the lungs for an unknown reason.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients with certain medical conditions that could interfere with the study results cannot participate.
Patients who are taking medications that might affect the study results cannot participate.

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Verified sites

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Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium

Trial locations

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Investigated drugs

ENV-101 is a medication being studied for its potential to treat lung fibrosis, specifically in patients with idiopathic pulmonary fibrosis (IPF). The trial aims to evaluate how effective and safe this medication is over a period of 24 weeks. Participants in the study will receive this medication to see if it can help improve their lung function and manage symptoms associated with lung fibrosis.

TALADEGIB

What is already known about the treatment

ENV-101 – ENV-101 is administered orally in the form of tablets. It is currently being studied in clinical trials, specifically in a Phase 2 trial, to evaluate its safety and effectiveness for treating idiopathic pulmonary fibrosis (IPF). The main therapeutic indication for ENV-101 is to manage and potentially improve lung function in patients with IPF. At the molecular level, ENV-101 works by targeting specific pathways involved in the fibrotic process, aiming to reduce the progression of fibrosis in lung tissue. It is classified pharmacologically as an anti-fibrotic agent.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue. This scarring, known as fibrosis, leads to a progressive decline in lung function. The exact cause of the disease is unknown, which is why it is termed "idiopathic." As the disease progresses, individuals may experience increasing difficulty in breathing and persistent dry cough. Over time, the lungs become less efficient at transferring oxygen into the bloodstream. This condition primarily affects middle-aged and older adults.