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
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Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 may not be if
Participants were excluded from the study if any of the following criteria apply:
Had 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 had not resolved clinically during screening period
Had significant haemoptysis
Had 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
Was being treated with antimicrobial therapy for tuberculosis (TB)
Was 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 planned 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
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | 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
