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 on Investigational Medication for Non-Cystic Fibrosis Bronchiectasis (NCFB)
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: Between 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.
This study investigates the effects of an investigational medication on individuals with Non-Cystic Fibrosis Bronchiectasis (NCFB). NCFB is a lung condition characterized by persistent cough, chronic sputum production, and frequent respiratory infections. The study aims to evaluate the safety, efficacy, and tolerability of two different dosing regimens of the investigational medication compared to a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine.
Participants in the study will be randomly assigned to one of three study arms. They will receive either one of the two dosing regimens of the investigational medication or a placebo. The study involves regular site or phone visits at monthly intervals to monitor participants' health and response to the treatment. Participants will undergo various assessments to ensure their safety and to measure the effectiveness of the treatment.
- Who can participate
- Adults aged 18 to 85 years with a history of NCFB, characterized by cough, chronic sputum production, or recurrent respiratory infections.
- Must have had at least 2 moderate or 1 severe pulmonary exacerbations in the past year and a predicted FEV1 of 30% or more - Study Details
- Participants will be assigned to one of three study arms: two different dosing regimens of the investigational medication or a placebo.
- Monthly site or phone visits are required to monitor health and treatment response. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine
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