A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week
Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in
Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease
(COPD) with Type 2 inflammation

Participants with a physician diagnosis of 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-bronchodilator FEV1/FVC ratio <0.70 and
post-bronchodilator FEV1 % predicted >30% and <=70%)
- Medical Research Council (MRC) Dyspnea Scale grade >=2
- Patient-reported history of signs and symptoms of chronic bronchitis (chronic
productive cough) for 3 months in the year up to screening in the absence of
other known causes of chronic cough
- Documented history of high exacerbation risk defined as exacerbation history
of >=2 moderate* or >=1 severe** within the year prior to inclusion. At least one
exacerbation should have occurred while the patient was taking ICS/LAMA/LABA
(or LAMA/LABA if ICS is contradicted). Moderate exacerbations are recorded by
the Investigator and defined as AECOPD that require either systemic
corticosteroids (intramuscular (IM), intravenous, or oral) and/or antibiotics.
One of the two required moderate exacerbations has to require the use of
systemic corticosteroids. Severe exacerbations are recorded by the Investigator
and defined as AECOPD requiring hospitalization or observation >24 hours in
emergency department/urgent care facility
- Background triple therapy (ICS + LABA + LAMA) for 3 months prior to
randomization with a stable dose of medication for >=1 month prior to Visit 1;
Double therapy LABA + LAMA allowed if ICS is contraindicated
- Evidence of Type 2 inflammation: Patients with blood eosinophils >=300
cells/microliter at Visit 1

- COPD diagnosis for less than 12 months prior to randomization
- Participants with current diagnosis of asthma according to the Global
Initiative for
Asthma (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,
etc) or another diagnosed pulmonary or systemic disease associated with
elevated peripheral eosinophil counts
- Cor pulmonale, evidence of right cardiac failure
- Long-term treatment with oxygen >4.0 L/min OR if a participant requires more
than
2.0 L/min in order to maintain oxygen saturation >88%
- Hypercapnia requiring BiPAP
- AECOPD as defined in inclusion criteria within 4 weeks prior to or during the
screening period
- Respiratory tract infection within 4 weeks prior to screening, or during the
screening period
- History of, or planned pneumonectomy or lung volume reduction surgery.
Patients who are participating in the acute phase of a pulmonary rehabilitation
program, ie, who started rehabilitation <4 weeks prior to screening (Note:
patients in the maintenance phase of a rehabilitation program can be included)
- Diagnosis of α-1 anti-trypsin deficiency