This clinical trial is focused on studying treatments for severe asthma with an eosinophilic phenotype. This type of asthma is characterized by high levels of a specific type of white blood cell called eosinophils, which can lead to more frequent and severe asthma attacks. The study will compare the effectiveness of a new medication called GSK3511294 (depemokimab) with two existing treatments, mepolizumab and benralizumab. These medications are given as injections under the skin and are designed to help control asthma symptoms by targeting specific proteins in the body that contribute to inflammation.
The purpose of the study is to evaluate how well GSK3511294 works compared to the other two treatments in managing asthma symptoms and preventing asthma attacks over a period of 52 weeks. Participants in the study will receive either GSK3511294, mepolizumab, or benralizumab, and some may receive a placebo. The study will monitor the frequency of asthma attacks and other measures of asthma control, such as lung function and quality of life, to determine the effectiveness and safety of the treatments.
Throughout the study, participants will have regular check-ups to assess their asthma symptoms and overall health. The study aims to provide valuable information on whether GSK3511294 is as effective as the current treatments for people with severe asthma with an eosinophilic phenotype. This research could potentially lead to new treatment options for individuals living with this challenging condition.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current asthma treatment.
A pregnancy test is required for women of childbearing potential to ensure safety before starting the trial.
2randomization and treatment allocation
Participants are randomly assigned to receive either GSK3511294 (depemokimab), mepolizumab, or benralizumab. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.
The study involves a double-dummy design, where participants receive both active treatment and placebo injections to maintain blinding.
3treatment administration
GSK3511294 (depemokimab) is administered as a 100 mg subcutaneous injection every 26 weeks.
Mepolizumab is administered as a 100 mg subcutaneous injection every 4 weeks.
Benralizumab is administered as a 30 mg subcutaneous injection every 4 weeks.
4ongoing monitoring
Participants attend regular clinic visits to monitor asthma control and any side effects. These visits include assessments of lung function and questionnaires about asthma symptoms.
The study lasts for 52 weeks, during which the frequency of asthma exacerbations and overall asthma control are evaluated.
5final assessment
At the end of the 52-week period, a final assessment is conducted to evaluate the effectiveness of the treatment.
Participants complete final questionnaires and undergo lung function tests to measure any changes from the start of the study.
Who Can Join the Study?
Participants must be adults or adolescents aged 12 years or older. In some countries, only adults aged 18 years or older can participate.
Participants must have been diagnosed with asthma by a doctor for at least 2 years.
Participants must have been receiving either mepolizumab or benralizumab treatment for at least 12 months and have shown improvement, such as fewer asthma attacks or reduced use of oral corticosteroids.
Participants must have been regularly using medium to high doses of inhaled corticosteroids for at least 12 months. If using medium doses, they must also use a long-acting beta-agonist.
Participants must be currently using at least one additional asthma control medication, such as a long-acting beta-agonist, long-acting muscarinic antagonist, leukotriene receptor antagonist, or theophylline.
Participants can be male or female. Female participants must not be pregnant or breastfeeding and must use effective birth control if they are of childbearing potential. They must also have negative pregnancy tests before and during the study.
Participants must be able to give informed consent, meaning they understand the study and agree to follow its rules. In France, participants must be affiliated with or beneficiaries of a social security category.
Who Cannot Join the Study?
Patients who do not have severe asthma with an eosinophilic phenotype cannot participate. This type of asthma is characterized by high levels of a specific type of white blood cell called eosinophils.
Patients who have not previously benefited from anti-IL-5/5R therapy are excluded. This therapy targets specific proteins involved in the inflammation process in asthma.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups only.
Patients who are part of a vulnerable population may be excluded. This refers to groups of people who might be at higher risk of harm or exploitation.
GSK3511294 (depemokimab) is a medication being studied for its effectiveness in treating severe asthma in patients with an eosinophilic phenotype. It is administered as an injection under the skin every 26 weeks. The goal of this medication is to reduce asthma exacerbations and improve overall asthma control in patients who have previously responded well to similar treatments targeting the IL-5 pathway.
Mepolizumab is a medication used to treat severe asthma by targeting and reducing the activity of eosinophils, a type of white blood cell that can contribute to asthma symptoms. It is typically given as an injection and is used in patients who have not been adequately controlled with standard asthma treatments.
Benralizumab is another medication used for the treatment of severe asthma, particularly in patients with high levels of eosinophils. It works by reducing the number of eosinophils in the blood, helping to control asthma symptoms and prevent asthma attacks. It is administered as an injection and is often used when other asthma treatments have not been effective.
Severe asthma with an eosinophilic phenotype – This form of asthma is characterized by high levels of eosinophils, a type of white blood cell, in the airways. It often leads to frequent and severe asthma attacks, which can significantly impact daily life. The condition is typically resistant to standard asthma treatments, requiring specialized therapies targeting eosinophils. Symptoms may include persistent coughing, wheezing, shortness of breath, and chest tightness. The disease can progress with increasing inflammation and obstruction of the airways. Management often involves monitoring and adjusting treatment to control symptoms and prevent exacerbations.
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