BridgeMD
A Proof-of-Concept study to assess the efficacy, safety and tolerability of itepekimab (anti-IL-33 mAb) in participants with non-cystic fibrosis bronchiectasis
EU CTIS ID: 2023-508663-70-00
What this study is testing
Evaluate the efficacy of itepekimab compared with placebo on occurrence of pulmonary exacerbations (PEs) in non-cystic fibrosis bronchiectasis (NCFB)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant must be 18 to 85 years of age inclusive.
- Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent respiratory infections).
- Participants with a FEV1 % predicted ≥30%.
- Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months.
You likely can't join if
- Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis.
- Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease
- Known allergy to itepekimab or to excipients
- Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study
- Unstable ischemic heart disease
- Cardiomyopathy or other relevant cardiovascular disorder
See the full eligibility criteria
- Participant must be 18 to 85 years of age inclusive.
- Clinical history consistent with NCFB (cough, chronic sputum production and/or recurrent respiratory infections).
- Participants with a FEV1 % predicted ≥30%.
- Participants with at least 2 moderate or 1 severe Pulmonary exacerbations (PEs) in the past 12 months.
- Have bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis.
- Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease
- Known allergy to itepekimab or to excipients
- Live-attenuated vaccine(s) within 4 weeks prior to Screening or plans to receive such vaccines during the study
- Unstable ischemic heart disease
- Cardiomyopathy or other relevant cardiovascular disorder
- Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening
- History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening.
- Known or suspected immunodeficiency disorder.
- Pulmonary exacerbation which has not resolved clinically during screening period.
- Have significant haemoptysis.
- Have any clinically significant abnormal laboratory values at Screening or diseases or disorders.
- History of lung transplantation.
- History of malignancy within 5 years before Screening, or during the screening period
- Currently being treated with antimicrobial therapy for tuberculosis (TB).
- Currently on active treatment for allergic bronchopulmonary aspergillosis (ABPA).
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Canada
- Chile
- Turkey
- China
- Argentina
- United States
- Japan
- United Kingdom
- Brazil
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Canada; Chile; Turkey; China; Argentina and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.