This study aims to evaluate the effectiveness and safety of the drug zampilimab, also known as CHF10067, in people living with idiopathic pulmonary fibrosis. This condition is a type of lung disease where the tissue in the lungs becomes thick and scarred over time, making it harder to breathe. The research will compare different doses of zampilimab, which is given through an intravenous infusion, meaning the medicine is delivered directly into a vein using a liquid solution, against a placebo.
During the initial part of the study, participants will receive either the medication or the placebo for a period of 24 weeks. The study will monitor how the treatment affects lung function, specifically looking at the forced vital capacity, which is the total amount of air a person can exhale after taking a deep breath. Following this period, there is an option to continue in an extended phase of the study for an additional 24 weeks.
Who Can Join the Study?
You must provide written informed consent, which means you agree to take part in the study after being told all the details.
You must be male or female and at least 40 years old.
The doctor must believe you have a life expectancy (how long a person is expected to live) of at least 1 year.
Your body weight must be at least 45 kg.
You must have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF), a condition that causes scarring in the lungs, within the last 8 years.
A recent High-resolution computed tomography (HRCT), which is a detailed type of X-ray scan used to look at the lungs, must have been done within the last 6 months to confirm your diagnosis.
Your Forced Vital Capacity (FVC), which is the total amount of air you can breathe out after taking a deep breath, must be at least 45% of what is expected for a healthy person of your age and size.
Your ratio of forced expiratory volume in the first second to FVC must be 0.7 or higher, which measures how much air you can blow out quickly in one second.
Your diffusing capacity of the lung for carbon monoxide (DLCO), which measures how well your lungs move oxygen from the air into your blood, must be at least 25% of the expected normal value.
Your oxygen saturation (SpO2), which is the amount of oxygen in your blood, must be greater than 90% even when using a nasal cannula (a small tube placed in the nose to provide extra oxygen) at a flow of 4 liters per minute.
Who Cannot Join the Study?
Having a confirmed diagnosis of coeliac disease, which is a condition where the body reacts poorly to gluten.
Having a low respiratory tract infection, which is an infection in the lungs or airways, within the last 4 weeks.
Experiencing an acute exacerbation of IPF, which means a sudden and rapid worsening of shortness of breath related to your lung disease.
Having a current diagnosis or a past history of lung cancer.
Having emphysema, a lung condition where the air sacs are damaged, if it covers 50% or more of the lungs or is more widespread than the lung scarring.
Needing an organ transplant due to advanced lung scarring within the next 6 months.
Having uncontrolled health problems involving the heart, liver, digestive system, kidneys, hormones, metabolism, nervous system, or mental health.
Having an active or untreated tuberculosis infection, which is a serious bacterial infection that usually affects the lungs.
Using cytotoxic drugs, which are medicines that kill cells, or immunosuppressant drugs, which lower the body’s ability to fight infection, within the last 48 weeks.
Taking a high dose of corticosteroids, which are powerful anti-inflammatory medicines, for more than 10 days.
Having a known hypersensitivity or allergy to any of the inactive ingredients used to make the study medicine.
Having a history of a severe allergic or anaphylactic reaction to specific types of proteins used in medical treatments called monoclonal antibodies.
Zampilimab is a medication given through an IV infusion to help study its effects on people with idiopathic pulmonary fibrosis, a condition that causes scarring in the lungs.
Idiopathic pulmonary fibrosis – This condition involves the development of thick, scarred tissue within the lungs. The exact cause of this scarring is unknown. As the disease progresses, the lung tissue becomes stiff and loses its elasticity. This stiffness makes it increasingly difficult for the lungs to expand and contract properly. Over time, the accumulation of scar tissue interferes with the ability of the lungs to transfer oxygen into the bloodstream.
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