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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham - School of Medicine- Site Number : 8400003
  Birmingham, Alabama, United States Recruiting
• University of Miami Dermatology Clinical Trials Unit- Site Number : 8400015
  Miami, Florida, United States Recruiting
• Finlay Medical Research- Site Number : 8400010
  Miami, Florida, United States Recruiting
• Private Practice - Dr. David Kavtaradze- Site Number : 8400017
  Cordele, Georgia, United States Recruiting
• University of Kansas Medical Center- Site Number : 8400005
  Kansas City, Kansas, United States Recruiting
• Johns Hopkins Bayview Medical Center- Site Number : 8400009
  Baltimore, Maryland, United States Recruiting

+35 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: contact-us@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.