Last updated 15 days ago
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
300 patients around the world
Available in Chile, United States
Sanofi
300Patients around the world
This study is for people with
Bronchiectasis
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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.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).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.
SponsorSanofi
Conditions
Bronchiectasis
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06280391
