This study is looking at Chronic Obstructive Pulmonary Disease, which is a lung condition that makes it hard to breathe and causes symptoms like coughing and shortness of breath. The study will test a medication called depemokimab, which is given as an injection under the skin. Some people in the study will receive depemokimab while others will receive placebo. People taking part will also continue using their regular inhaled medicines, which include salbutamol for quick relief of breathing problems and a combination of inhaled medications that help keep the airways open and reduce inflammation in the lungs. The study will also use a sterile 0.9% sodium chloride solution, which is a salt water solution.
The purpose of the study is to find out if depemokimab works better than placebo in treating people with this lung disease who have a type of inflammation called Type 2 inflammation. The study will look at whether the medication can reduce the number of times symptoms suddenly get worse, which doctors call exacerbations. These are times when breathing problems become much worse and may need treatment with antibiotics or steroid pills, or sometimes even a visit to the emergency room or hospital.
During the study, people will receive treatment for up to 104 weeks, which is about two years. The doctors will check how often breathing problems get worse, how long it takes before problems get worse, and how the disease affects daily life and breathing symptoms. The study will compare results between people receiving depemokimab and those receiving placebo to see if the medication helps reduce flare-ups and improves quality of life for people with this lung condition.
1Initial treatment period begins
Upon joining the study, you will be randomly assigned to receive either depemokimab or placebo. This is a double-blind study, which means neither you nor your doctor will know which treatment you are receiving.
You will receive your assigned treatment through subcutaneous injection, which means the medication will be injected under your skin.
Throughout the study, you will continue taking your regular inhaled medications for chronic obstructive pulmonary disease. These include your inhaled corticosteroid, long-acting muscarinic receptor antagonist, and long-acting beta2-adrenergic receptor agonist.
2Rescue medication availability
You will have access to salbutamol sulfate as a rescue medication. This medication is available as an inhalation powder with a dose of 100 micrograms per inhalation.
The product name is Novolizer Salbutamol. You should use this medication when you experience breathing difficulties or symptoms that require immediate relief.
This rescue medication is taken through inhalation, meaning you breathe it in through your mouth using the inhaler device.
3Regular monitoring at Week 52
At Week 52 of the study, specific assessments will be conducted to measure how the treatment is working.
You will complete the St. George’s Respiratory Questionnaire, which is a set of questions about how your lung condition affects your daily life. Your answers at this point will be compared to your answers at the beginning of the study.
You will also complete the Evaluating Respiratory Symptoms questionnaire, which asks about your breathing symptoms. This will also be compared to your baseline responses.
4Ongoing assessment throughout the study
Throughout the entire study period, your breathing function will be monitored. This includes measurements of how much air you can breathe out in one second, called forced expiratory volume in one second.
Any worsening of your condition, called exacerbations, will be recorded. These are episodes when your symptoms get worse and may require additional treatment.
The study will track whether these exacerbations are moderate, meaning they require treatment with antibiotics or steroids, or severe, meaning they require a visit to the emergency department or hospital admission.
5Study completion
The study is expected to continue until the end of 2029. Your individual participation duration will be determined by the study protocol.
Throughout your participation, the study will evaluate how well the treatment reduces the frequency of exacerbations and improves your quality of life and breathing symptoms.
Safety monitoring will occur throughout the entire study period to assess any side effects or adverse reactions to the treatment.
Who Can Join the Study?
You must be between 40 and 80 years old when you sign the consent form to join the study
You must have a high number of eosinophils in your blood. Eosinophils are a type of white blood cell that can cause inflammation in your airways
You must have moderate to severe COPD (a lung disease that makes it hard to breathe) with frequent worsening of symptoms, which means:
You have been diagnosed with COPD for at least 1 year
A breathing test shows that your lung function is reduced, with results showing your FEV1 (the amount of air you can breathe out in one second) is between 30% and 80% of what is expected for someone your age and size
You have had at least 2 moderate flare-ups or 1 severe flare-up of your COPD symptoms in the past 12 months before joining the study
Your CAT score must be 10 or higher at the first visit. The CAT is a questionnaire that measures how much COPD affects your daily life
You must be a current or former cigarette smoker with a smoking history of at least 10 pack-years. A pack-year means smoking one pack of cigarettes per day for one year
You must be using the best inhaler treatment for at least 6 months before joining the study. This treatment must include three types of medications: an inhaled corticosteroid (a medicine that reduces inflammation), a LAMA (a medicine that helps open your airways), and a LABA (another medicine that helps keep your airways open). These can be in separate inhalers or combined in one inhaler
Your body mass index (BMI) must be 16 or higher. BMI is a measure of body weight compared to height
Both men and women who meet certain requirements can participate in the study
Who Cannot Join the Study?
The source data does not contain specific exclusion criteria (reasons why patients cannot participate) for this clinical trial
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this study
Exclusion criteria typically include things like other medical conditions, certain medications being taken, previous treatments, or test results that would make it unsafe or inappropriate for someone to join the study
Depemokimab is an investigational medication being studied for the treatment of chronic obstructive pulmonary disease (COPD) in adults who have Type 2 inflammation. This medication is being tested to see if it can help improve the condition of people with this specific type of COPD. In this study, depemokimab will be compared against a placebo to determine how well it works and how safe it is for patients.
Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The disease causes the airways to become narrowed and the air sacs in the lungs to lose their stretchiness. Over time, the lungs produce more mucus which can further block the airways. People with this condition often experience shortness of breath, persistent cough, and wheezing. The disease typically gets worse gradually over the years. Flare-ups, called exacerbations, can occur where symptoms suddenly become more severe.
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