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

Korábbi kezelés

• Was being treated with antimicrobial therapy for tuberculosis (TB)
• Live-attenuated vaccine(s) within 4 weeks prior to Screening or planned to receive such vaccines during the study
• Clinically significant new abnormal electrocardiogram (ECG) within 6 months prior to, or at Screening

Más betegség

• Had bronchiectasis due to CF, hypogammaglobulinemia, common variable immunodeficiency, known active nontuberculous mycobacteria (NTM) lung infection, or pulmonary fibrosis
• Known or suspected immunodeficiency disorder
• History of lung transplantation
• History of malignancy within 5 years before Screening, or during the screening period
• 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
• Unstable ischemic heart disease
• Cardiomyopathy or other relevant cardiovascular disorder
• 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.

Laborértékek

• Had any clinically significant abnormal laboratory values at Screening or diseases or disorders

Egyéb

• Participants were excluded from the study if any of the following criteria apply:
• Pulmonary exacerbation which had not resolved clinically during screening period
• Had significant haemoptysis

• 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