This study focuses on Idiopathic Pulmonary Fibrosis, a condition where the lung tissue becomes thick and scarred over time, making it difficult to breathe. The purpose of the study is to evaluate the effectiveness and safety of a drug called BMS-986278, also known as admilparant, which is an LPA1 antagonist. Participants in the study will receive either the study drug in the form of a film-coated tablet taken by mouth or a placebo.
During the study, researchers will monitor how the treatment affects the lungs, specifically looking at changes in Forced Vital Capacity, which is a measure of the total amount of air a person can exhale after taking a deep breath. The study also observes how the condition changes over time and examines the distance a person can walk during a 6-minute walk test, which is a common way to check physical fitness and lung function. The investigation will take place over a period of 52 weeks.
Who Can Join the Study?
You must be at least 40 years old when you sign the study agreement.
You must have a diagnosis of idiopathic pulmonary fibrosis, which is a condition that causes scarring in the lungs, within the last 7 years.
Your diagnosis must be confirmed by a high-resolution computed tomography (HRCT), which is a special type of detailed X-ray scan used to look closely at the lungs.
The scan must show evidence of usual interstitial pneumonia, a specific pattern of lung scarring.
If you are currently taking the medications pirfenidone or nintedanib, you must have been taking a steady, unchanging dose for at least 90 days.
If you are not taking pirfenidone or nintedanib, you must not have taken either of these medicines in the 28 days before joining the study.
Women who are able to become pregnant must use a highly effective form of contraception (birth control) and must have a negative pregnancy test through urine or blood before starting.
Men who are sexually active with women who can become pregnant must agree to use male barrier contraception, such as a condom.
Who Cannot Join the Study?
Having a history of a stroke (when blood flow to part of the brain is interrupted) or a transient ischemic attack (a temporary period of symptoms similar to a stroke that resolves quickly) within the 3 months before the study starts.
Showing signs or symptoms of heart failure (a condition where the heart cannot pump enough blood to meet the body’s needs) while resting.
Having a current malignancy (a type of cancer that is currently present in the body).
Having a previous malignancy (a history of cancer) that has returned within the last 2 years.
Having a biopsy (a medical procedure where a small sample of tissue is removed) that shows signs of possible cancer that cannot be ruled out.
Having interstitial lung disease (a group of disorders that cause scarring or inflammation in the lungs) caused by known specific factors, such as hypersensitivity pneumonitis (lung inflammation caused by breathing in certain dusts or chemicals), autoimmune associated ILD (lung disease caused by the body’s immune system attacking its own tissues), or sarcoidosis (a disease that causes small clumps of inflammatory cells to form in the lungs).
Admilparant is an experimental medication taken by mouth in tablet form. It is being studied to see if it can help improve lung function in people living with a condition called idiopathic pulmonary fibrosis.
Idiopathic pulmonary fibrosis – This is a condition where the lung tissue becomes thick and scarred over time. This scarring makes it difficult for the lungs to function properly. As the disease progresses, the lung tissue becomes increasingly stiff. This stiffness makes it harder for the lungs to expand and contract during breathing. The scarring typically develops gradually within the lungs.
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