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

Investigation of an Investigational Medication for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Recruiting
18 years - 85 years
All
Phase 2
300 participants needed
11 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 09 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 widened, leading to a build-up of mucus that can cause infections and breathing difficulties. The study aims to evaluate the safety and effectiveness of two different dosing regimens of the investigational medication compared to a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.

Participants will be randomly assigned to one of three study arms: two arms will receive different doses of the investigational medication, and one arm will receive a placebo. The study will include regular site or phone visits at monthly intervals to monitor the participants' health and response to the treatment. Participants will undergo various assessments to ensure their safety and to evaluate the effects of the treatment.

  • Who can participate. Participants aged 18 to 85 years with a history of NCFB, who have had at least 2 moderate or 1 severe pulmonary exacerbations in the past year, and have a FEV1 % predicted of 30% or more.
  • Study Details. Participants will be assigned to one of three study arms, with some receiving the investigational medication and others receiving a placebo.
  • Study Timelines: The study will last 47-77 weeks.

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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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