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Bronchiectasis Clinical Research Study for adults, currently being treated with established therapy
Study on Investigational Medication for Bronchiectasis
Recruiting
18 years - 85 years
All
Phase
2
300 participants needed
6 Locations
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
Updated on
06 Mar 2025.
Study ID: NCT06280391
This study investigates a treatment for bronchiectasis, a chronic lung condition where the air passages become enlarged due to the weakening of the airway walls. This can lead to symptoms like shortness of breath, coughing, and frequent lung infections.
Participants will receive either the investigational medication or a placebo, in addition to their usual medications. 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 ECGs and CT scans.
- Who can participate: Adults aged 18 to 85 with bronchiectasis may qualify. All genders are eligible.
- Study details: Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The treatment is randomly assigned, and the study is blinded, meaning neither participants nor doctors know who receives which treatment.
- Study Timelines and Visits: The study will last between 44 to 77 weeks. The study requires 12 site visits and up to 5 phone visits.
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