NCT07053423

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Dupilumab	Pharmaceutical form:Solution for injection-Route of administration:SC injection
DRUG	Placebo	Pharmaceutical form:Solution for injection-Route of administration:SC injection

Timeline

• Start date: 2025-09-22
• Primary completion: 2028-12-23
• Completion: 2029-02-15
• First posted: 2025-07-08
• Last updated: 2026-03-24

Locations

53 sites across 15 countries: United States, Argentina, Brazil, China, Denmark, France, Hungary, Italy, Netherlands, Poland, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study