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Sponsor: Sanofi
Conditions: Bronchiectasis
Interventions: Itepekimab (SAR440340), Placebo
Countries: United States, Argentina, Brazil, Canada, Chile, China, Czechia, Denmark
ACT18018 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study with 3 treatment groups. The purpose of this study is to evaluate efficacy, safety and tolerability with 2 dosing regimens of itepekimab compared with placebo in male and/or female participants with NCFB aged 18 years of age up to 85 years of age (inclusive). Study details include: * The study duration (screening, 24-52-week treatment, 20-week safety follow-up) will be up to 47-77 weeks. * The treatment duration will be up to 24-52 weeks. * The follow-up duration will be 20 weeks. * Site/phone visits are at a monthly interval.
Sex: ALL
Age: 18 Years to 85 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
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