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

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  18 to 85

Participation 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.