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RECRUITINGPhase 4INTERVENTIONAL

A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive). Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.

Who May Be Eligible (Plain English)

Who May Qualify: Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening: - Current or former smokers with a smoking history of ≥10 pack-years - Moderate-to-severe COPD (post-BD FEV1/FVC ratio \<0.70 and post-BD FEV1 % predicted \>30% and ≤70%) - Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10 - Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations - Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated - Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation). - Mucus score cutoff of ≥3 Who Should NOT Join This Trial: - A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma - Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts - Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period - Diagnosis of α-1 anti-trypsin deficiency - Any biologic therapy (including experimental treatments and dupilumab) - Participants on treatment with mucolytics unless on stable therapy for \>6 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening: * Current or former smokers with a smoking history of ≥10 pack-years * Moderate-to-severe COPD (post-BD FEV1/FVC ratio \<0.70 and post-BD FEV1 % predicted \>30% and ≤70%) * Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10 * Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations * Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated * Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation). * Mucus score cutoff of ≥3 Exclusion Criteria: * A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma * Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts * Treatment with oxygen \>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period * Diagnosis of α-1 anti-trypsin deficiency * Any biologic therapy (including experimental treatments and dupilumab) * Participants on treatment with mucolytics unless on stable therapy for \>6 months The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatments Being Tested

DRUG

Dupilumab

Pharmaceutical form:Solution for injection-Route of administration:SC injection

DRUG

Placebo

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Locations (20)

University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
Birmingham, Alabama, United States
Finlay Medical Research- Site Number : 8400010
Miami, Florida, United States
Johns Hopkins Bayview Medical Center- Site Number : 8400009
Baltimore, Maryland, United States
American Health Research - Charlotte- Site Number : 8400013
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004
Winston-Salem, North Carolina, United States
Clinical Research Associates of Central PA- Site Number : 8400002
DuBois, Pennsylvania, United States
REX Clinical Trials - Beaumont- Site Number : 8400011
Beaumont, Texas, United States
Investigational Site Number : 0320001
San Miguel de Tucumán, Tucumán Province, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320003
Buenos Aires, Argentina
Associacao Proar- Site Number : 0760005
Salvador, Estado de Bahia, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006
São Paulo, Brazil
Incor - Instituto do Coracao- Site Number : 0760001
São Paulo, Brazil
Investigational Site Number : 1560001
Guangzhou, China
Investigational Site Number : 2080003
Aalborg, Denmark
Investigational Site Number : 2080002
Vejle, Denmark
Investigational Site Number : 2500008
La Tronche, France
Investigational Site Number : 2500001
Lille, France
Investigational Site Number : 2500005
Lyon, France