This study is looking at Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes it hard to breathe and causes repeated flare-ups where symptoms get worse. The study will test a medication called depemokimab, which is given as a solution for injection under the skin. Some people in the study will receive depemokimab while others will receive placebo. Participants may also use salbutamol sulfate as an inhalation powder when needed for breathing relief. The purpose of the study is to see how well depemokimab works compared to placebo in people with this lung disease who have a specific type of inflammation called type 2 inflammation.
The study will include adults between 40 and 80 years old who have moderate to severe lung disease with frequent flare-ups, meaning they have had at least two moderate flare-ups or one severe flare-up in the past year. Participants need to have higher levels of certain white blood cells called eosinophils in their blood. They should already be using three types of inhaled medications for their lung condition, including an inhaled steroid, for at least six months before joining the study. The study will look at how often flare-ups happen during treatment and will measure this over time.
During the study, participants will receive injections of either the study medication or placebo for up to 104 weeks. The study will measure how many flare-ups occur, how long it takes until the first flare-up happens, and how the disease affects daily life and breathing symptoms. Doctors will also track how many flare-ups require emergency room visits or hospital stays. Throughout the study, participants will continue taking their regular inhaled medications as prescribed by their doctor.
1Initial treatment period begins
Upon joining the study, you will be randomly assigned to receive either depemokimab or placebo. Neither you nor your doctor will know which treatment you are receiving.
The treatment will be administered as an injection under the skin (subcutaneous injection). The placebo is a sterile salt water solution that contains no active medication.
You will continue taking your regular inhaled medications during the study, including your inhaled corticosteroid, long-acting muscarinic receptor antagonist, and long-acting beta2-adrenergic receptor agonist. These are medications that help keep your airways open and reduce inflammation in your lungs.
2Rescue medication availability
Throughout the study, you will have access to salbutamol (also known as Novolizer Salbutamol) as a rescue medication.
This medication is an inhalation powder with a dose of 100 micrograms per inhalation.
You should use this medication when you experience sudden breathing difficulties or worsening of your symptoms. It works quickly to open your airways and make breathing easier.
3Regular study visits and assessments
You will attend regular study visits where various assessments will be performed.
During these visits, your breathing function will be tested using a device that measures how much air you can breathe out and how quickly (called spirometry).
Blood samples will be taken to measure the level of certain white blood cells called eosinophils in your blood.
You will be asked to complete questionnaires about your breathing symptoms and quality of life, including the St. George’s Respiratory Questionnaire and the Evaluating Respiratory Symptoms questionnaire.
4Monitoring at Week 52
At Week 52 (approximately one year after starting the study), specific assessments will be performed.
Your responses to the questionnaires about breathing symptoms and quality of life will be compared to your initial responses to measure any changes.
These assessments help determine how the treatment has affected your symptoms and daily functioning over the course of the year.
5Ongoing monitoring throughout the study
Throughout the entire study period, any worsening of your condition (called exacerbations) will be recorded.
An exacerbation is when your breathing symptoms suddenly get worse and may require additional treatment, a visit to the emergency department, or hospitalization.
The study will track how often these episodes occur and how severe they are.
The total study duration is expected to continue until the end of 2029.
6Safety monitoring
Your safety will be monitored throughout the study.
Any side effects or health changes you experience will be recorded and evaluated.
You should report any new or worsening symptoms to the study staff during your visits or as instructed.
Who Can Join the Study?
You must be between 40 and 80 years old when you join the study.
You must have an elevated blood eosinophil count, which means higher than normal levels of a specific type of white blood cell in your blood.
You must have moderate to severe COPD with frequent worsening episodes, which means your lung disease has been diagnosed for at least 1 year and causes regular flare-ups of symptoms.
Your lung function tests must show that the ratio between air you can breathe out in one second and the total air you can breathe out is less than 0.70.
Your lung function tests must show that you can breathe out more than 30% but no more than 80% of the air volume expected for someone of your age and size after using an inhaler medication.
You must have had at least 2 moderate flare-ups or 1 severe flare-up of your COPD in the past 12 months before joining the study.
Your COPD assessment test score must be 10 or higher at the first visit, which measures how much your lung disease affects your daily life.
You must be a current or former cigarette smoker who has smoked at least the equivalent of one pack of cigarettes per day for 10 years.
You must have been using the best available inhaler therapy for at least 6 months, which includes three types of medications: an inhaled steroid, a long-acting medication that relaxes airway muscles, and a long-acting medication that opens airways.
Your body mass index must be 16 or higher, which is a measure of your body weight in relation to your height.
You must be male or an eligible female participant.
Who Cannot Join the Study?
The source data does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed exclusion criteria information, it is not possible to list specific conditions or situations that would prevent participation
Exclusion criteria typically include things like other medical conditions, certain medications, pregnancy status, or recent participation in other studies, but these are not specified in the available information
Depemokimab is a medication being tested in this clinical trial for people with COPD (a lung disease) who have a specific type of inflammation called Type 2 inflammation. This medicine is being studied to see if it can help improve the condition of patients with this type of COPD better than a placebo (a dummy treatment with no active medicine).
Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The airways in the lungs become narrowed and damaged, which blocks airflow and makes it harder for air to move in and out. Over time, the lungs produce more mucus than normal, which further blocks the airways. People with this condition often experience shortness of breath, persistent cough, and wheezing. The disease progresses gradually, with symptoms becoming worse over the years. Periods of sudden worsening, called exacerbations, can occur when symptoms become more severe than usual.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.
Belgium 
Croatia 
Denmark 
France 
Germany 
Hungary 
Ireland 
Norway 
Poland 
Portugal 
Slovakia 
Spain 
Sweden 
The Netherlands 
