Not recruitingRare disease

Study on the Effectiveness and Safety of LTP001 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 breathing becomes difficult over time. The study will test a new treatment called LTP001, which is taken as a hard capsule by mouth. The purpose of the study is to see how effective and safe LTP001 is compared to a placebo in people with IPF.

Participants in the study will be randomly assigned to receive either the LTP001 treatment or a placebo. The study will last for about 26 weeks, during which participants will take the assigned capsules regularly. Throughout the study, participants will have their lung function monitored to see if there are any changes in their breathing capacity. This will help researchers understand how well the treatment works and if there are any side effects.

The study aims to provide valuable information on the potential benefits of LTP001 for people living with Idiopathic Pulmonary Fibrosis. By comparing the effects of the treatment to a placebo, researchers hope to determine if LTP001 can improve lung function and overall health in patients with this challenging condition.

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
Randomization
Upon joining the study, participants are randomly assigned to receive either the investigational product LTP001 or a placebo. This process is blinded, meaning neither the participant nor the investigator knows which treatment is being administered.
Step 2
Treatment administration
Participants will take the assigned treatment orally in the form of hard gelatin capsules. The dosage is either 1 mg or 5 mg, depending on the specific treatment group assigned.
The treatment period lasts for 26 weeks, during which participants will continue taking the capsules as directed.
Step 3
Monitoring and assessments
Throughout the 26-week treatment period, participants will undergo regular assessments to monitor their health and the effects of the treatment.
These assessments include measuring changes in lung function, specifically the Forced Vital Capacity (FVC), which is a measure of lung volume.
Additional assessments may include physical examinations, laboratory tests, electrocardiograms (ECGs), and monitoring of vital signs.
Step 4
End of treatment evaluation
At the end of the 26-week treatment period, participants will undergo a final evaluation to assess the overall impact of the treatment.
This evaluation will include a comparison of lung function from the start to the end of the treatment period, as well as any changes in symptoms or quality of life.

Who can join the trial?

9 criteria

You must provide written informed consent before any study assessments are done. This means you agree to participate after understanding the study details.
You need to be a male or female who is at least 40 years old.
You should have been diagnosed with **Idiopathic Pulmonary Fibrosis (IPF)** within the last 5 years. This diagnosis should follow specific guidelines and may involve special lung imaging tests or biopsies.
Your **Forced Vital Capacity (FVC)**, which is a measure of lung function, should be at least 45% of what is expected for your age and size, with no significant worsening before starting the study.
Your **Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)**, which is another lung function test, should be at least 25% of what is expected, with no significant worsening before starting the study.
The study doctor should believe that you are unlikely to die from causes other than IPF in the next 2 years.
The study doctor should believe that you are unlikely to need a lung transplant during the study.
If you are taking medications called **nintedanib** or **pirfenidone** for IPF, you must have been on a stable dose for at least 8 weeks before starting the study.
You should be able to communicate well with the study doctor and understand and follow the study requirements.

Who cannot join the trial?

8 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, making it hard to breathe.
Patients who are currently participating in another clinical trial are not eligible.
Patients who have had a recent lung infection or illness that affects their breathing may be excluded.
Patients who have a history of severe heart problems may not be able to join the study.
Patients who are pregnant or breastfeeding cannot participate in the trial.
Patients who have a known allergy to the study medication or its ingredients will be excluded.
Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
Patients who have a history of drug or alcohol abuse may be excluded from the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Fakultni Nemocnice Brno
Verified
Brno, Czechia
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Responsive
Essen, Germany

Trial locations

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Investigated drugs

Nintedanib
is a medication used in the trial to help slow down the progression of idiopathic pulmonary fibrosis (IPF). It works by blocking certain enzymes that contribute to the scarring of lung tissue, which can help improve lung function and breathing in patients with IPF.
Pirfenidone
is another treatment option in the study for patients with idiopathic pulmonary fibrosis. It helps reduce lung scarring and inflammation, potentially slowing the disease's progression and preserving lung function.
Investigational Product A
is a new treatment being tested in the trial for its effectiveness in treating idiopathic pulmonary fibrosis. The goal is to determine if it can improve lung function and slow disease progression compared to existing treatments.
Investigational Product B
is another new therapy under investigation in the study. Researchers are evaluating its safety and ability to improve lung function in patients with idiopathic pulmonary fibrosis, aiming to offer a new treatment option for this condition.

Ltp001

What is already known about the treatment

Nintedanib – Nintedanib is administered orally in the form of capsules. It is currently approved for use in treating idiopathic pulmonary fibrosis (IPF) and is well-documented in medical literature for this purpose. The main therapeutic indication is to slow the progression of IPF, a chronic lung disease. At the molecular level, Nintedanib works by inhibiting multiple tyrosine kinases, which are enzymes involved in the pathways that lead to fibrosis. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Idiopathic Pulmonary Fibrosis – Idiopathic pulmonary fibrosis is a chronic lung disease characterized by the thickening and scarring of lung tissue, leading to a progressive decline in lung function. The exact cause of this condition is unknown, which is why it is termed "idiopathic." Over time, the scarring, or fibrosis, makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. Patients often experience symptoms such as persistent dry cough and shortness of breath, especially during physical activity. As the disease progresses, these symptoms can become more severe, impacting daily activities and quality of life. The progression of the disease varies among individuals, with some experiencing a rapid decline in lung function while others may have a slower progression.