A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.
This study is being conducted to evaluate the effectiveness and safety of depemokimab in individuals living with Chronic Obstructive Pulmonary Disease, commonly known as COPD. This condition is a long-term lung disease that makes it difficult to breathe. The study specifically focuses on patients who have type 2 inflammation, which is a specific way the body’s immune system reacts and causes swelling in the airways. Participants may also use salbutamol sulfate, an inhaled medication used to help open the airways.
During the study, participants will be assigned to receive either depemokimab or a placebo through a subcutaneous injection, which is a shot given just under the skin. The study is designed so that neither the participants nor the researchers know which treatment is being administered. This approach helps ensure that the results are as accurate as possible.
Who Can Join the Study?
Participants must be men or women.
The person must have an eosinophilic phenotype, which means their blood contains a specific type of white blood cell called an eosinophil that is present in higher amounts than normal.
The person must have moderate to severe Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe.
The lung condition must have been officially diagnosed for at least 1 year.
Lung function tests must show specific results, including a FEV1/FVC ratio (a measure of how much air you can blow out quickly compared to how much you can hold) of less than 0.70 and an FEV1 (the amount of air you can force out of your lungs in one second) that is between 30% and 80% of what is expected for a healthy person.
These lung measurements must be taken after using a bronchodilator, which is a medicine that helps open up the airways.
The person must have a high risk of exacerbations, which are sudden worsening of symptoms or “flare-ups” of the lung disease.
The person must have had exactly one moderate flare-up in the last 12 months.
The person must have additional risk factors, such as a high mMRC score or CAT score, which are tools used to measure how much shortness of breath and symptoms affect daily life.
The person may have chronic bronchitis, which involves long-term inflammation and mucus in the airways.
The person must be a current or former smoker with a history of at least 10 pack-years (a measurement calculated by multiplying the number of packs of cigarettes smoked per day by the number of years smoked).
The person must have been using inhaler therapy for at least 3 months, specifically using combinations of medicines like corticosteroids (to reduce swelling), LABA, or LAMA (to help relax and open the airways).
The person’s Body Mass Index (BMI), which is a measure of body weight relative to height, must be at least 16 kg/m².
Who Cannot Join the Study?
People whose main lung problem is not Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes it hard to breathe.
People who currently have or have previously been diagnosed with asthma, a condition where your airways swell and narrow.
People who had asthma as a child that did not go away before they turned 18 or has come back since then.
People with other significant lung diseases that the doctor decides are not caused by Chronic Obstructive Pulmonary Disease.
People who have had more than one moderate exacerbation, which is a sudden worsening of symptoms, or any severe exacerbation in the last 12 months.
People who have had pneumonia, a lung infection, a worsening of their lung condition, or a lower respiratory tract infection, which is an infection in the lungs or breathing tubes, within the 4 weeks before the first visit.
People who have had surgery to remove part of their lung or who plan to have lung volume reduction surgery or an endobronchial valve procedure, which are operations used to help improve breathing by changing how the lungs work.
People who are currently in the active stage of a pulmonary rehabilitation program, which is a supervised program of exercise and education to help people with lung disease.
People with chronic hypercapnia, which is a long-term buildup of too much carbon dioxide in the blood, that requires the use of machines like Bi-Level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) to help them breathe.
People who need to use oxygen supplementation, which means using extra oxygen through a device, to help with their breathing.
Depemokimab is a medication given as an injection under the skin. It is being tested to see if it can help improve the condition of people with chronic obstructive pulmonary disease (COPD) who have a specific type of inflammation in their airways.
Salbutamol is an inhaled powder used as a background treatment. It is a common medicine used to help open up the airways and make breathing easier.
Chronic Obstructive Pulmonary Disease – This is a long-term lung condition that causes airflow blockage and breathing difficulties. It is often characterized by persistent inflammation in the airways and lung tissue. Over time, the damage to the lungs can make it increasingly difficult to move air in and out of the body. The condition typically progresses slowly, with symptoms becoming more noticeable as the airways become more obstructed. It can involve various changes in the lungs, such as the narrowing of the small airways.
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