RecruitingRare disease

A study of the humanised IgG1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1 to treat adults 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 study focuses on individuals with Idiopathic Pulmonary Fibrosis, a condition where the lungs become scarred and thickened over time, making it harder to breathe. The goal of the study is to evaluate the safety and effectiveness of a new investigational medicine called ABBV-142. This treatment is a humanised igg1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1, which is a type of protein-based medicine designed to target specific processes in the body. ABBV-142 will be given to participants through intravenous administration, meaning it is delivered directly into a vein as a solution for injection/infusion.

During the study, some participants will receive the active medicine, while others will receive a placebo. The research involves monitoring how the medicine affects the body over a period of time to see if it can change the way the disease progresses. The course of the study includes regular check-ups to observe any changes in health or how the lungs are functioning.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
Participation begins with the administration of either the investigational product or a placebo. the investigational product is a humanised igg1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1, which is delivered as a solution for injection or infusion directly into a vein, a process known as intravenous administration.
The placebo is an inactive substance used for comparison purposes.
Step 2
Monitoring lung function
Throughout the study, forced vital capacity (the maximum amount of air that can be exhaled from the lungs after taking a deep breath) is measured to track changes in disease activity.
Specific measurements of forced vital capacity and predicted forced vital capacity percentage are recorded at week 24 and week 52 to assess how the lungs are functioning.

Who can join the trial?

8 criteria

You must be at least 40 years old.
You must have been diagnosed with Idiopathic Pulmonary Fibrosis, which is a condition that causes scarring of the lungs, within the last 7 years.
Your diagnosis must be confirmed by a doctor using a high-resolution Computed Tomography (HRCT) scan, which is a detailed type of X-ray that shows clear images of the lungs, taken within the last 12 months.
Your lung scans must show a specific pattern of scarring known as Usual Interstitial Pneumonia (UIP) or probable UIP, which are common patterns seen in this lung disease.
If your scan results are unclear, your diagnosis may still be accepted if it was previously confirmed through a lung biopsy, which is a procedure where a small piece of lung tissue is removed to be examined under a microscope.
Regarding antifibrotics, which are medications used to slow down lung scarring, you must either have been taking a stable dose for at least 8 weeks or not taking them at all for at least 4 weeks.
Your Forced Vital Capacity (FVC), which is a measurement of the total amount of air you can exhale forcefully, must be at least 45% of what is considered normal for a person of your age and size.
Your diffusing capacity (DLCO), which is a test that measures how well your lungs move oxygen from the air into your blood, must be at least 25% of the predicted normal value.

Who cannot join the trial?

3 criteria

You have airways obstruction, which means your breathing tubes are partially blocked, measured by a specific test showing that the amount of air you can force out of your lungs in one second is too low.
You have experienced an acute IPF exacerbation, which is a sudden and rapid worsening of your lung condition, within the last 4 months or during the initial screening period.
You have had a lower respiratory tract infection, such as pneumonia (an infection in the lung tissue) or active tuberculosis (a serious bacterial infection), that required antimicrobials (medicines like antibiotics used to kill germs) within the last 4 weeks or during the screening period.

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Verified sites

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Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Semmelweis University
Responsive
Budapest, Hungary
Soedersjukhuset AB
Responsive
Stockholm, Sweden

Trial locations

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Investigated drugs

ABBV-142 is an experimental medicine being tested to see if it can help treat people with idiopathic pulmonary fibrosis. It is an antibody delivered through a vein via an injection or infusion to target specific receptors in the body that may play a role in the disease.

HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1

What is already known about the treatment

HUMANISED IGG1 LALAPS-YTE MONOCLONAL ANTIBODY AGAINST LYSOPHOSPHATIDIC ACID RECEPTOR 1 - This investigational medicine is administered as a liquid through an intravenous infusion into a vein. Currently being studied in clinical trials, it is being tested to see if it can help treat idiopathic pulmonary fibrosis, a condition that causes scarring in the lungs. It works as a specialized protein that targets and blocks a specific receptor on cells to prevent the signals that lead to lung scarring. This drug is classified as a monoclonal antibody, which is a type of targeted biological therapy.

Investigated diseases

Idiopathic Pulmonary Fibrosis - This is a condition where the lung tissue becomes thick and scarred over time. The scarring makes it difficult for the lungs to function properly and for oxygen to enter the bloodstream. It is characterized by the progressive buildup of fibrous tissue within the lungs. As the disease advances, the lungs become stiffer and less elastic. This process gradually reduces the amount of air the lungs can hold.