Bronchiectasis Clinical Research Study for adults, currently being treated with established therapy

Investigating a Medicine Given by Injection Under the Skin for Bronchiectasis

Recruiting
18 years - 85 years
All
Phase 2
1 Location

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory tract disease, Bronchiectasis
  • Age: 18 years - 85 years
  • Gender: All


Updated on 17 Sep 2024. Study ID: TX216936

This study investigates bronchiectasis, a long-lasting lung disease that causes the air passages in the lungs to enlarge due to weakened airway walls. Symptoms include shortness of breath, coughing up mucus or blood, wheezing, and frequent lung infections. The purpose of this study is to explore an investigational medication that might be used alongside standard treatments for bronchiectasis, which are not always effective.

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 using a prefilled syringe every two weeks. The study is blinded, meaning that neither the participants nor the study doctors will know who receives the investigational medication or the placebo. Study procedures include physical exams, vital signs checks, medical history reviews, and several specific tests like spirometry and chest CT scans.

  • Who can participate: Individuals aged 18 to 85 with bronchiectasis who need additional treatment beyond their current therapies may participate. Key eligibility includes having a diagnosis of bronchiectasis.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. Participants will continue their usual medications during the study.
  • Study Timelines and Visits: The study will last between 44-77 weeks. The study requires 12 site visits and up to 5 phone visits.

Pre-Screener

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