Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Itepekimab Q2W
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
  • Drug: Itepekimab (SAR440340)
    Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
    Other names:
    • REGN3500
Experimental
Itepekimab Q4W
SC administration of Itepekimab every 4 weeks (Q4W) with alternating placebo administration at the 2week interval between active IMP as SC injection for up to 52 weeks
  • Drug: Itepekimab (SAR440340)
    Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
    Other names:
    • REGN3500
  • Drug: Placebo
    Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous
Placebo Comparator
Placebo
SC administration of matching placebo Q2W for up to 52 weeks
  • Drug: Placebo
    Pharmaceutical form: solution for injection in pre-filled syringe. Route of administration: subcutaneous

Recruiting Locations

University of Alabama at Birmingham- Site Number : 8400040
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.