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

  • STATUS
    Recruiting
  • End date
    Aug 11, 2026
  • participants needed
    300
  • sponsor
    Sanofi
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Updated on 6 February 2025
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Summary

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.

Details
Condition Bronchiectasis
Age 18years - 85years
Treatment Placebo, Itepekimab (SAR440340)
Clinical Study IdentifierNCT06280391
SponsorSanofi
Last Modified on6 February 2025

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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