Overview
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.
Eligibility
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.