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NCT Number: NCT07053423

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

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.

Recruiting

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Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site Number : 0320001, San Miguel de Tucumán, Tucumán Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dupilumab

Drug

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

Other names: SAR231893, Dupixent

Placebo

Drug

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

Primary outcomes

  1. Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)

    Time frame: Baseline to Week 24

    The score is calculated by counting the number of bronchopulmonary segments which on CT scans contain at least one mucus plugs. The score ranges from 0 up to a maximum score of 18 corresponding to the 18 bronchopulmonary segments present in most people. In this system, a mucus plug is defined as a complete occlusion of the airway imaged at Total Lung Capacity (TLC). Higher scores indicate worse outcome.

Secondary outcomes

  1. Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)

    Time frame: Baseline to Week 24

  2. Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT

    Time frame: Baseline to Week 24

  3. Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)

    Time frame: Baseline to Week 24

  4. Change from baseline to Week 24 in Reactance area (AX) measured by FOT

    Time frame: Baseline to Week 24

  5. Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities

    Time frame: Baseline to Week 36

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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.

Acronym: AEOLUS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 8, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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