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Trial eligibility change
| eligibility_criteria | Inclusion 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. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | → | Inclusion 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 Exclusion Criteria: 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. |
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