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 the Effects of an Investigational Medication for NCFB

Recruiting
18 years - 85 years
All
Phase 2
300 participants needed
52 Locations

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
  • Age: 18 years - 85 years
  • 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.

Updated on 30 Jan 2025. Study ID: NCT06280391

This study investigates the effects of an investigational medication on individuals with non-cystic fibrosis bronchiectasis (NCFB). NCFB is a condition where the airways in the lungs become damaged, leading to symptoms like coughing and producing phlegm. The study will compare two different doses of the investigational medication to a placebo, which is a substance that looks like the medication but has no active ingredients.

Participants will be randomly assigned to one of three study arms and will receive either one of the two dosing regimens of the investigational medication or a placebo. The study will involve regular site or phone visits each month to monitor the participants' health and gather data on the medication's effects.

  • Who can participate: Adults aged 18 to 85 with NCFB who have had at least two moderate or one severe pulmonary exacerbations in the past year and have a predicted FEV1 of 30% or more may be eligible.
  • Study details: Participants will be randomly assigned to receive either one of two doses of the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.

Find a Study Location to Connect

What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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