A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age With Non-Cystic Fibrosis Bronchiectasis

Sanofi70 enrolled

Overview

This is a randomized, double-blind, placebo-controlled study to measure the reduction in mucus plug score at 24 weeks of treatment with SAR445399 compared with placebo in adult participants aged 18 to 80 years with non-cystic fibrosis bronchiectasis (NCFB).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Non-cystic Fibrosis Bronchiectasis

Interventions

SAR445399BIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: injection

PlaceboBIOLOGICAL

Pharmaceutical form: solution for injection Route of administration: injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must be 18 to 80 years of age inclusive, at the time of signing the informed consent * Clinical history consistent with NCFB, such as chronic productive cough and/or recurrent respiratory infections * Documented evidence of at least 2 PEx defined as episodes requiring a physician-prescribed course of antibiotics (oral and/or IV) for ≥5 days for signs and symptoms of respiratory infection within the 12 months prior to the Screening Visit * Radiologic evidence of bronchiectasis, confirmed by a chest HRCT * A minimum MPS of 4 (out of maximum 18) on chest HRCT performed before Baseline Visit * Current sputum production with a documented history of chronic expectoration lasting ≥3 months within the previous 12 months * Participants must have a post-bronchodilator FEV1 ≥30% of predicted normal value Exclusion Criteria: * A primary diagnosis of smoking-related COPD or asthma as determined by the Investigator. Participants with comorbid smoking-related COPD may be included if bronchiectasis is confirmed as their primary diagnosis and is the predominant cause of their respiratory symptoms * Diagnosis of ABPA or any of the allergic bronchopulmonary mycoses * Active NTM lung infection or incomplete NTM treatment course * Bronchiectasis due to any of the following: CF, CVID, AAT or PCD * History of significant hemoptysis (requiring medical intervention and/or requiring blood transfusion) * Current tobacco smokers * Known or suspected immunosuppression, including history of invasive opportunistic infections (eg., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the Investigator * Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease, including but not limited to connective tissue diseases (eg., systemic lupus erythematosus, scleroderma, polymyositis, dermatomyositis, mixed connective tissue disease), rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, Hashimoto's thyroiditis, Graves' disease, primary biliary cirrhosis, and psoriasis vulgaris The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (4)

Pulmonary Associates - Phoenix - East McDowell Road- Site Number : 8400008

Phoenix, Arizona, United States

Advanced Pulmonary Research Institute- Site Number : 8400001

Loxahatchee Groves, Florida, United States

Hull and Hull Medical Specialists- Site Number : 8400002

Plantation, Florida, United States

Clinical Research Associates of Central Pennsylvania- Site Number : 8400006

DuBois, Pennsylvania, United States

Outcomes

Primary Outcomes

Change from baseline to Week 24 in mucus plug score (MPS) derived from chest high-resolution computerized tomography (HRCT)

Mucus plug score is determined by counting the number of bronchopulmonary segments that contain at least one mucus plug, defined as a complete occlusion of the airway The total MPS ranges from 0 to 18 with higher scores indicating worse outcome

Time frame: from baseline up to Week 24

Secondary Outcomes

Change from baseline to Week 24 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

Post-bronchodilator forced expiratory volume in 1 second

Time frame: from baseline up to Week 24

Change from baseline to Week 52 in post-bronchodilator forced expiratory volume in 1 second (FEV1)

Post-bronchodilator forced expiratory volume in 1 second

Time frame: from baseline up to Week 52

Change from baseline to Week 24 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

Pre-bronchodilator forced expiratory volume in 1 second

Time frame: from baseline up to Week 24

Change from baseline to Week 52 in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

Pre-bronchodilator forced expiratory volume in 1 second

Time frame: from baseline up to Week 52

Annualized rate of pulmonary exacerbation (PEx) from baseline up to Week 24

Pulmonary exacerbations (PEx) were defined as a worsening of 3 or more major symptoms over a 48-hour period, including increased cough, increased sputum volume or changes in sputum consistency, increased sputum purulence, increased breathlessness, decreased exercise tolerance, fatigue and/or malaise, and hemoptysis. These symptoms had to lead to a healthcare provider's decision to prescribe systemic antibiotics

Data from ClinicalTrials.gov

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