Bronchiectasis Clinical Research Study for adults, currently being treated with established therapy
Study of Investigational Medication for Adults with Bronchiectasis
Study Overview
This study is looking for individuals ages 18 to 85 with bronchiectasis who require treatment in addition to their current therapies. Bronchiectasis is a long-lasting lung disease characterized by the enlargement of the air passages inside the lungs due to weakening of the airway vessel wall, which leads to symptoms such as shortness of breath, coughing up sputum and sometimes blood, wheezing (high pitch sound while breathing), and frequent lung infections.
Available standard treatments for bronchiectasis are not always effective. The investigational medication (itepekimab) is being investigated as a possible treatment for bronchiectasis. It binds to a specific substance in the body that is crucial for the function of certain cells in our immune system. Itepekimab is an injectable treatment and is administered under the skin (subcutaneously) via a prefilled syringe. Injections will be given every two weeks.
If you are interested in learning more about this study, we encourage you to complete a brief questionnaire to help determine if you may qualify to participate and be referred to a site recruiting in your area for further evaluation.
Study Details
This study will have about 300 participants in approximately 20 countries.
All participants will receive either the investigational medication or placebo (in addition to their usual medications). The treatment is randomly chosen for each participant. There is a 2 in 3 chance of receiving the investigational medication.
This study is a blinded study. Blinded means that neither the people taking part, nor the study doctors know who is given the investigational medicine or the placebo.
The total study duration will be between 44-77 weeks, depending on when you start the study. Treatment will last at least 24 weeks and no longer than 52 weeks. There will be 12 site visits and up to 5 phone visits. Study tests include:
· Physical exam
· Vital signs
· Medical history
· Bronchiectasis severity index
· Electrocardiogram (ECG)
· Chest CT (computed tomography scan)
· Spirometry
· Blood and urine testing
· Assessments / questionnaires
There is no cost to participate. All study-related exams, study-related medications and study-related medical care is provided. There is no insurance required to take part in this study. You may be compensated for time and travel.
Eligibility Criteria
This study investigates a treatment for bronchiectasis, a long-lasting lung disease. Bronchiectasis is characterized by the enlargement of the air passages in the lungs due to a weakening of the airway walls. This condition can cause symptoms such as shortness of breath, coughing up mucus, wheezing, and frequent lung infections.
Participants will receive either the investigational medication or a placebo along with their usual treatments. The investigational medication is given as an injection under the skin every two weeks. Study procedures include physical exams, vital signs checks, medical history reviews, and various tests such as chest CT scans and blood tests.
- Who can participate: Adults aged 18 to 85 with bronchiectasis may be eligible to participate. All genders are welcome.
- Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
- Study timelines and visits: The study will last 44-77 weeks. The study requires 12 visits.
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