A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
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
You may not be if
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.
Clareo Health | A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
