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

Completed · Phase 2 · Has a placebo group

Conditions studied: Bronchiectasis

In brief

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.

Key facts

Study ID

NCT06280391

Run by

Sanofi

People needed

312

Starts

2024-02-20

Expected to finish

2026-02-02

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400012 — Phoenix, Arizona, United States
• Southern California Institute for Respiratory Diseases- Site Number : 8400002 — Los Angeles, California, United States
• Institute Healthcare Assessment- Site Number : 8400037 — San Diego, California, United States
• Allianz Research Institute- Site Number : 8400013 — Westminster, California, United States
• Allianz Research Institute CO- Site Number : 8400038 — Aurora, Colorado, United States
• University of Connecticut Health Center- Site Number : 8400020 — Farmington, Connecticut, United States
• Yale New Haven Hospital- Site Number : 8400065 — New Haven, Connecticut, United States
• Advanced Pulmonary Research Institute- Site Number : 8400007 — Loxahatchee Groves, Florida, United States
• Clever Medical Research- Site Number : 8400001 — Miami, Florida, United States
• My Community Research Center- Site Number : 8400023 — Miami, Florida, United States
• High Quality Research- Site Number : 8400047 — Miami, Florida, United States
• Destiny Research Center- Site Number : 8400049 — Palmetto Bay, Florida, United States
• Avanza Medical Research Center- Site Number : 8400018 — Pensacola, Florida, United States
• Private Practice - Dr. Frank Hull - Plantation- Site Number : 8400010 — Plantation, Florida, United States
• Northwestern Memorial Hospital- Site Number : 8400043 — Chicago, Illinois, United States
• University of Kansas Medical Center- Site Number : 8400045 — Kansas City, Kansas, United States
• University of Michigan Health System - Ann Arbor- Site Number : 8400055 — Ann Arbor, Michigan, United States
• Pulmonary and Medicine Associates- Site Number : 8400057 — Warren, Michigan, United States
• Washington University- Site Number : 8400046 — St Louis, Missouri, United States
• NYU Langone Medical Center- Site Number : 8400032 — New York, New York, United States
• American Health Research - Charlotte- Site Number : 8400017 — Charlotte, North Carolina, United States
• Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400009 — Huntersville, North Carolina, United States
• Southeastern Research Center- Site Number : 8400008 — Winston-Salem, North Carolina, United States
• Clinical Research Associates of Central PA - Dubois- Site Number : 8400005 — DuBois, Pennsylvania, United States
• University of Alabama at Birmingham- Site Number : 8400040 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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