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.
Who can join
Ages 40 to 85 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Dupilumab (drug)
- Placebo (drug)
Sponsor: Sanofi · Participants: 218 · Started: Sep 22, 2025
Contact the study team
- Trial Transparency email recommended (Toll free for US & Canada) · Phone: 800-633-1610
Official record on ClinicalTrials.gov — NCT07053423
Locations in the U.S.
| Alabama | University of Alabama at Birmingham - School of Medicine- Site Number : 8400003, Birmingham |
| Florida | Finlay Medical Research- Site Number : 8400010, Miami University of Miami Dermatology Clinical Trials Unit- Site Number : 8400015, Miami |
| Georgia | Private Practice - Dr. David Kavtaradze- Site Number : 8400017, Cordele |
| Kansas | University of Kansas Medical Center- Site Number : 8400005, Kansas City |
| Maryland | Johns Hopkins Bayview Medical Center- Site Number : 8400009, Baltimore |
| Massachusetts | Brigham & Women's Hospital- Site Number : 8400014, Boston |
| North Carolina | American Health Research - Charlotte- Site Number : 8400013, Charlotte Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004, Winston-Salem |
| Pennsylvania | Clinical Research Associates of Central Pennsylvania- Site Number : 8400002, DuBois |
| Texas | REX Clinical Trials - Beaumont- Site Number : 8400011, Beaumont |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.