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
Study of Investigational Medication for Non-cystic Fibrosis Bronchiectasis
Study 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 Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Bronchiectasis
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Age: 18 years - 85 years
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Gender: All
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.
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational medication in participants with non-cystic fibrosis bronchiectasis (NCFB). This study involves comparing two dosing regimens of the investigational medication to a placebo to determine its effectiveness in managing the symptoms of NCFB.
Participants will be randomly assigned to one of three study arms, receiving either one of the two different dosing regimens of the investigational medication or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the investigational medication or the placebo. Monthly site or phone visits will be conducted to monitor participants' health and collect data on the medication's effects.
- Who can participate: Adults aged 18 to 85 with a clinical history of non-cystic fibrosis bronchiectasis and at least 30% predicted FEV1 are eligible. Participants must have experienced at least two moderate or one severe pulmonary exacerbation in the past year.
- Study details: Participants will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medicine but contains no active ingredients.
