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Dupilumab for Airway Inflammation in COPD

This study is looking at how Dupilumab, a medication given by injection under the skin, affects airway inflammation (swelling and irritation in the breathing tubes) in people with Chronic Obstructive Pulmonary Disease (COPD). Researchers want to see if Dupilumab can reduce mucus plugging, improve lung function, lessen flare-ups (exacerbations), and improve quality of life. You may be able to join if you are between 40 and 85 years old, have a doctor's diagnosis of moderate-to-severe COPD, and have a history of smoking. The main goal is to measure changes in lung mucus over 24 weeks. The current recruitment status is unclear.

Study design
This is a multinational, randomized, double-blind, placebo-controlled study with two treatment groups, planning to enroll 218 participants.
What's involved
The study will last up to 40 weeks, with treatment for up to 24 weeks. You would have 9 visits during the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes from baseline to Week 24, suggesting follow-up during this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07053423

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

Recruiting
PHASE4Ages 40–85InterventionalTreatment
Sanofi
~218 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:DupilumabPlacebo

At a glance

Recruiting sites
68 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)
Measured over Baseline to Week 24

Conditions

Chronic Obstructive Pulmonary Disease

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Chronic Obstructive Pulmonary Disease

Where it's being run

68 sites across 41 states
France7
China4
Netherlands4
Seoul-teukbyeolsi4
Hungary3
Switzerland3
North Carolina2
Argentina2

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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