This clinical trial is focused on studying asthma, a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The study is testing a new treatment called GSK5784283, which is an anti-TSLP antibody. An antibody is a protein that helps the immune system fight off harmful substances. The trial will compare different doses of GSK5784283 to a placebo to see how well it works in adults aged 18 to 75 who have asthma that is not well controlled by their current treatments.
The purpose of the study is to evaluate the effects of three different dose levels of GSK5784283 on a specific marker of inflammation in the lungs called the fraction of exhaled nitric oxide (FeNO). Participants will receive either the study drug or a placebo through an injection under the skin. The study will last for up to 52 weeks, during which participants will have regular check-ups to monitor their asthma symptoms and overall health. The study will also look at other factors like lung function and asthma control over time.
Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how the treatment affects their asthma. The trial aims to find the most effective dose of GSK5784283 that can help improve asthma symptoms and control. This research could lead to new treatment options for people with asthma who struggle to manage their condition with existing medications.
1joining the study
Upon joining the study, participants will be required to provide informed consent. This involves signing a document that confirms understanding of the study’s requirements and agreeing to comply with the procedures outlined.
Participants must demonstrate acceptable inhaler and spirometry techniques during the initial phase of the study.
2screening and initial assessments
Participants will undergo a series of assessments to confirm eligibility. This includes verifying a documented history of asthma for at least two years and evidence of variable airflow obstruction.
A history of asthma exacerbations within the past year will be reviewed, and the requirement for regular treatment with medium or high-dose inhaled corticosteroids will be confirmed.
3randomization and treatment allocation
Participants will be randomly assigned to receive either the study medication GSK5784283 or a placebo. The study is double-blind, meaning neither participants nor researchers will know which treatment is being administered.
The medication is administered as a solution for injection under the skin (subcutaneous use).
4treatment phase
Participants will receive the assigned treatment over a period of 26 weeks. The effects of three different dose levels of GSK5784283 will be evaluated.
Regular monitoring will occur to assess the impact on the fraction of exhaled nitric oxide (FeNO), blood eosinophil counts, lung function, and asthma control.
5follow-up and extension phase
After the initial 26-week treatment phase, participants may enter an extension phase lasting up to 52 weeks. This phase will continue to monitor changes in FeNO, blood eosinophil counts, and lung function.
Participants will be required to attend follow-up visits at specified intervals to ensure ongoing assessment of their asthma control and overall health.
Who Can Join the Study?
Informed Consent: You must be able to understand the study and agree to participate by signing a consent form.
You must be able to use an inhaler and perform a breathing test correctly during the initial period of the study.
Age: You must be between 18 and 75 years old.
You must have been diagnosed with asthma by a doctor for at least 2 years.
You must show signs of asthma-related breathing issues, such as improvement in breathing after using a bronchodilator (a medicine that helps open airways) or have had tests showing airway sensitivity in the past 2 years.
You must have had a worsening of asthma symptoms in the past year that required extra treatment, like taking steroid pills or visiting the emergency room.
You must have been using medium or high doses of inhaled corticosteroids (a type of asthma medication) regularly for at least 6 months before the study.
You must be using at least one other asthma medication regularly for at least 3 months before the study.
Weight: You must weigh at least 40 kg (about 88 pounds).
Gender: Both males and females can participate. If you are a female who can have children, you must not be pregnant or breastfeeding and must use a highly effective birth control method. You will also need to have a negative pregnancy test before starting the study and during the study.
Who Cannot Join the Study?
Patients with any other significant health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent respiratory infection.
Patients who have a history of severe allergic reactions.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients who have used certain medications that might affect the study results.
Patients with a history of drug or alcohol abuse.
Patients who have had a recent surgery.
Patients with a history of non-compliance with medical treatments.
GSK5784283 is a medication being studied for its potential to help people with asthma. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it hard to breathe. This medication is designed to target a specific protein in the body that is involved in the inflammation process. By blocking this protein, the medication may help reduce inflammation in the airways, making it easier for people with asthma to breathe. The study is looking at how well this medication works in people whose asthma is not well controlled with their current treatments.
Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The progression of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. Triggers such as allergens, exercise, cold air, or stress can exacerbate symptoms. Over time, repeated inflammation may lead to structural changes in the airways, known as airway remodeling. Asthma is typically managed by avoiding triggers and monitoring symptoms to prevent exacerbations.
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