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

Launched by SANOFI · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called dupilumab to see if it can reduce inflammation and other problems in the airways of people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung condition that makes it hard to breathe and often causes coughing and mucus buildup. The study will compare dupilumab to a placebo (a treatment with no active medicine) to find out if dupilumab can help improve lung function, reduce flare-ups, and make daily life better for people with COPD.

People who might be eligible for this study are adults aged 40 to 85 who have been diagnosed with moderate to severe COPD, have a history of smoking, and experience frequent or severe flare-ups despite using standard inhaled treatments. Participants will need to have signs of a specific type of inflammation in their blood and mucus buildup in their lungs. The study will last up to 40 weeks, including about 24 weeks of treatment, and involves nine visits to the study center. It’s important that participants do not have asthma or other lung diseases, have not recently had a lung infection, and have not used similar biologic treatments before. If you or a loved one fits these criteria and are interested, this study might offer a chance to try a new treatment aimed at improving COPD symptoms.

Gender

ALL

Eligibility 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