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

Investigating an Investigational Medication for a Lung Condition

Recruiting
18 years - 85 years
All
Phase 2
300 participants needed
32 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 14 Apr 2025. Study ID: NCT06280391

This study investigates the effectiveness and safety of an investigational medication for treating Non-Cystic Fibrosis Bronchiectasis (NCFB). NCFB is a lung condition where the airways become widened and scarred, leading to symptoms like a persistent cough, production of sputum, and frequent lung infections. The study will compare two different dosing regimens of the investigational medication to a placebo, which is a substance that looks like the medication but does not contain any active ingredients.

Participants will be randomly assigned to one of three study arms: two arms receiving different doses of the investigational medication and one arm receiving the placebo. Throughout the study, participants will have monthly site or phone visits to monitor their health and collect data on the medication's effects.

  • Who can participate: Adults aged 18 to 85 with a history of NCFB can participate. Key criteria include having a predicted FEV1 of at least 30% and experiencing at least two moderate or one severe pulmonary exacerbations in the past year.
  • Study details: Participants will be randomly assigned to receive either 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

We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language