A study of the humanised IgG1 lalaps-yte monoclonal antibody against lysophosphatidic acid receptor 1 to treat adults with idiopathic pulmonary fibrosis
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.
Who Can Join the Study?
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 Study?
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.
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.
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.
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