This study aims to evaluate the efficacy and safety of a study drug known as BMS-986278, also referred to as admilparant, in individuals living with Progressive Pulmonary Fibrosis. Progressive Pulmonary Fibrosis is a condition where the lung tissue becomes thick and scarred over time, making it harder to breathe. The treatment being tested is an LPA1 antagonist, which is a type of medication designed to block specific signals in the body that may contribute to the scarring of the lungs. This medication is taken as an oral usefilm-coated tablet.
Participants in the study will be randomly assigned to receive either the active medication or a placebo. The study is double-blind, meaning that neither the participants nor the researchers will know which specific treatment is being administered during the course of the trial. The process involves monitoring changes in Forced Vital Capacity, which is a measurement of the total amount of air a person can exhale from their lungs after taking a deep breath. The study will track these changes and other health factors over a period of time to see how the medication affects the progression of the disease.
Who Can Join the Study?
You must be at least 21 years old when you sign the study agreement.
You must have a diagnosis of interstitial lung disease, which is a condition where there is scarring or inflammation in the lungs, that shows signs of getting worse within the last 24 months.
A special type of detailed lung scan called a high-resolution computed tomography (HRCT) must show that at least 10% of your lung tissue has fibrosis, which is permanent scarring.
If you are currently taking the medicines 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 them in the 28 days before joining the study.
You may take certain immune-system medicines like mycophenolate mofetil, mycophenolic acid, azathioprine, or tacrolimus, but only if your dose has been stable for at least 90 days.
If you are not taking those specific medicines, you must not have taken them in the 28 days before the study starts.
You may take traditional disease-modifying antirheumatic drugs (DMARDs), which are medicines used to slow down diseases that affect the immune system, such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine, as long as your dose has been stable for at least 90 days.
If you are not taking these DMARDs, you must not have taken them in the 28 days before the study begins.
You may take biologic DMARDs (medicines made from living organisms, such as TNF blockers or IL-1 inhibitors) or Janus kinase (JAK) inhibitors (medicines that block specific proteins to reduce inflammation, such as tofacitinib or upadacitinib), provided your dose has been stable for at least 90 days.
If you are not taking these biologic or JAK inhibitors, you must not have taken them in the 28 days before the study starts.
Women who are able to become pregnant must use a very effective form of contraception (birth control) and must have a negative pregnancy test using urine or blood at the start of the study and before receiving the medication.
Men who are sexually active with women who can become pregnant must agree to use barrier contraception, such as a condom.
Who Cannot Join the Study?
People who have idiopathic pulmonary fibrosis, which is a specific type of lung scarring that causes unknown causes, with usual interstitial pneumonia (UIP), which is a specific pattern of lung damage seen on medical tests, cannot join.
Anyone who has had a stroke (a sudden loss of blood flow to the brain) or a transient ischemic attack (a temporary blockage of blood flow to the brain that acts as a warning sign for a stroke) in the 3 months before starting the study.
People who show signs of heart failure, a condition where the heart cannot pump enough blood to meet the body’s needs, while resting.
People who currently have malignancy, which is another word for cancer.
People who had cancer in the past but have been cancer-free for less than 2 years.
People who have had a biopsy, which is a medical procedure to remove a small piece of tissue for testing, that shows signs of cancer that cannot be ruled out.
People using systemic corticosteroids, which are strong medicines used to reduce inflammation, at a dose equivalent to more than 15 mg of prednisone per day within 4 weeks before the study or during the study.
Admilparant is an experimental medicine being tested to see if it can help improve lung function in people with progressive pulmonary fibrosis. It is taken as a tablet by mouth and works by blocking a specific protein in the body that may contribute to the progression of the disease.
Progressive Pulmonary Fibrosis – This condition involves the gradual thickening and scarring of the lung tissue. As the disease advances, the lung tissue becomes stiff and loses its elasticity. This changes how the lungs expand and contract during breathing. The scarring process occurs over time and continues to develop. It primarily affects the respiratory system by reducing the ability of the lungs to function properly.
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