A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants A
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 impr
| Condition(s) | Chronic Obstructive Pulmonary Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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 can participate | 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 |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Lead sponsor | Sanofi |
| Locations | Birmingham, Alabama, United States; Miami, Florida, United States; Cordele, Georgia, United States; Kansas City, Kansas, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States (+62 more sites) |
| Start date | 2025-09-22 |
| NCT ID | NCT07053423 |
| Official listing | https://clinicaltrials.gov/study/NCT07053423 |