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

Study on Airway Inflammation in COPD with Investigational Medication

Recruiting
40 years - 85 years
All
Phase 4
218 participants needed
4 Locations

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Obstructive Pulmonary Disease
  • Age: 40 years - 85 years
  • Gender: All

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.

This study investigates the effects of an investigational medication given subcutaneously on airway inflammation in people with Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to compare the investigational medication with a placebo, which is a substance that looks like the investigational medication but does not contain any medicine, to see how they affect airway inflammation, resistance, and remodeling, including mucus plugging. The study aims to understand how these changes might improve lung function, reduce exacerbations, and enhance quality of life for participants aged 40 to 85 years.

Participants will be randomly assigned to one of two study arms: one receiving the investigational medication and the other receiving a placebo. The study procedures will include regular assessments of lung function and airway inflammation. Participants will receive their assigned treatment for up to 24 weeks, and their progress will be monitored throughout the study duration, which will last up to 40 weeks.

  • Who can participate: Adults aged 40 to 85 years with a diagnosis of moderate-to-severe COPD can participate. Key eligibility factors include being a current or former smoker with a history of at least 10 pack-years, and having evidence of Type 2 inflammation.
  • Study details: Participants will continue their regular COPD therapy and will have their lung function and airway inflammation monitored throughout the study.
  • Study timelines and visits: The study will last 40 weeks. The study requires 9 visits.
Updated on 11 Feb 2026. Study ID: NCT07053423

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