Home › Trials › NCT07053423

Dupilumab injections to reduce airway inflammation in adults 40–85 with COPD

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.

Phase 4 Interventional Sanofi · NCT07053423

This trial will test whether dupilumab injections can reduce airway inflammation and mucus plugging and improve breathing, exacerbations, and quality of life in people aged 40–85 with moderate-to-severe COPD and evidence of type 2 inflammation.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment218 (estimated)
Ages40 Years to 85 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsdupilumab
Locations58 sites (Birmingham, Alabama and 57 other locations)
Trial IDNCT07053423 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 4 study with two parallel treatment groups comparing subcutaneous dupilumab to placebo over up to 24 weeks of treatment and up to 40 weeks total follow-up. The trial will measure airway inflammation, airway resistance, and structural remodeling including mucus plugging and link those imaging/biologic findings to changes in lung function, exacerbation frequency, and patient-reported quality of life. Eligible participants are adults 40–85 years old with moderate-to-severe COPD, a ≥10 pack-year smoking history, GOLD category E, and evidence of type 2 inflammation by blood eosinophil criteria while on background inhaled therapy. The study is being conducted at multiple international sites with several U.S. centers participating.

Who should consider this trial

Good fit: Adults aged 40–85 with physician-diagnosed moderate-to-severe COPD (post-bronchodilator FEV1/FVC <0.70 and FEV1 30–70% predicted), ≥10 pack-year smoking history, GOLD category E, on stable background inhaled therapy, and evidence of type 2 inflammation (blood eosinophils ≥300 cells/µL or ≥150 with prior ≥300).

Not a fit: Patients without elevated blood eosinophils, with mild COPD, non-smokers, or those with contraindications to dupilumab are unlikely to benefit from this treatment approach.

Why it matters

Potential benefit: If successful, dupilumab could reduce airway inflammation and mucus plugging, potentially improving lung function, reducing exacerbations, and improving quality of life for COPD patients with type 2 inflammation.

How similar studies have performed: Dupilumab and other type 2–targeting biologics have shown clear benefit in type 2 asthma, but their effectiveness in COPD remains less established and is the focus of this investigation.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 57 other locations

+8 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Obstructive Pulmonary Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.