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

Sanofi312 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

312

Conditions

Bronchiectasis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (138)

University of Alabama at Birmingham- Site Number : 8400040

Birmingham, Alabama, United States

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