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Study on the Effects of CAL101 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 treatment called CAL101, which is given as a solution through a vein, a method known as intravenous use. The treatment aims to see if CAL101 can help improve lung function in people with IPF.

The purpose of the study is to evaluate how effective and safe CAL101 is for patients with IPF. Participants in the study will receive either CAL101 or a placebo, which is a substance with no active medication. The study will last for about 28 weeks, during which the lung function of participants will be closely monitored to see if there are any improvements. The main focus will be on changes in the amount of air the lungs can hold, known as forced vital capacity (FVC).

Throughout the study, participants will be observed for any side effects or adverse events. The study will also track how many participants experience these events over a period of 40 weeks. This research is important to understand if CAL101 can be a beneficial treatment option for those living with IPF.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and initial assessment
Upon joining the study, you will undergo an initial assessment to confirm your eligibility. This includes reviewing your medical history and conducting tests to ensure you meet the study criteria, such as being 40 years or older and having a diagnosis of idiopathic pulmonary fibrosis (IPF).
A high-resolution computed tomography (HRCT) scan of your chest will be reviewed to confirm the pattern of lung disease. Your lung function will be measured, including forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO).
Step 2
Randomization and treatment assignment
You will be randomly assigned to receive either the study medication, CAL101, or a placebo. This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.
The treatment will be administered intravenously, which means it will be given through a vein. You will receive the treatment regularly over a period of 28 weeks.
Step 3
Treatment phase
During the 28-week treatment phase, you will receive the intravenous infusion of CAL101 or placebo. The frequency and exact schedule of these infusions will be explained to you by the study team.
You will continue any stable dose of antifibrotic medication, such as nintedanib or pirfenidone, if you were already taking it before the study, unless advised otherwise by the study team.
Step 4
Regular monitoring and assessments
Throughout the study, your health and lung function will be closely monitored. This includes regular visits to the study site for assessments and tests to measure changes in your lung function, particularly the FVC.
You will be asked to report any side effects or adverse events you experience during the study. This monitoring will continue for up to 40 weeks to ensure your safety and to gather comprehensive data.
Step 5
End of treatment and follow-up
At the end of the 28-week treatment period, you will undergo a final assessment to evaluate the effects of the treatment on your lung function and overall health.
You may be asked to return for follow-up visits to monitor your health and any long-term effects of the treatment. The study team will provide you with detailed instructions on these follow-up procedures.

Who can join the trial?

7 criteria

Must be 40 years of age or older at the time of giving consent to participate.
Must have a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) according to current international guidelines.
Must have a definite or probable pattern of usual interstitial pneumonia (UIP) on a chest scan called high-resolution computed tomography (HRCT) done within the last 12 months, confirmed by a central review. If a recent HRCT is not available, a new one will be used to check eligibility.
Must have a forced vital capacity (FVC) of at least 45% of what is predicted for a person of similar characteristics. FVC is a measure of lung function that shows how much air you can exhale after taking a deep breath.
Must have a Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) of at least 25% of what is predicted, corrected for hemoglobin levels. DLCO measures how well the lungs can transfer oxygen into the blood.
Must have a ratio of forced expiratory volume in 1 second (FEV1) to FVC of at least 0.7. This ratio helps assess lung function.
Must either be on a stable dose of antifibrotic medication (such as nintedanib or pirfenidone) for at least 8 weeks before screening or not have been treated with antifibrotics for at least 8 weeks before screening. If on antifibrotic medication, it is expected that the patient will continue it throughout the trial.

Who cannot join the trial?

3 criteria

Patients who do not have Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a lung disease that causes scarring of the lungs for an unknown reason.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
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Roskilde University
Roskilde, Denmark

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Investigated drugs

CAL101 is a medication being tested in this clinical trial for its potential to help people with idiopathic pulmonary fibrosis, a lung disease that makes it hard to breathe. The trial is looking at how well CAL101 works when given through an IV, which means it is delivered directly into the bloodstream. The main goal is to see if CAL101 can improve lung function by measuring changes in how much air a person can exhale after taking a deep breath, known as forced vital capacity. This study will compare the effects of CAL101 to a placebo over a period of 28 weeks to see if it can help improve breathing in patients with this condition.

What is already known about the treatment

CAL101 – CAL101 is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its potential use in treating idiopathic pulmonary fibrosis, a lung disease that causes scarring and affects breathing. The main goal of the study is to see if CAL101 can improve lung function by measuring changes in forced vital capacity, which is a measure of how much air a person can exhale after taking a deep breath. CAL101 works at the molecular level by targeting specific pathways that may reduce inflammation and scarring in the lungs, although its exact mechanism is still under investigation. It is classified as an investigational drug, meaning it is not yet approved for general medical use and is being tested for safety and effectiveness.

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 disease typically begins with shortness of breath and a persistent dry cough. As it progresses, patients may experience fatigue, unexplained weight loss, and clubbing of the fingers. Over time, the scarring makes it increasingly difficult for the lungs to transfer oxygen into the bloodstream. The exact cause of the fibrosis is unknown, which is why it is termed "idiopathic."