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Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

NCT04456673

CompletedPhase 3

Sponsor: Sanofi

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Dupilumab SAR231893, Inhaled Corticosteroid, Inhaled Long-Acting Beta Agonist, Inhaled Long-Acting Muscarinic Antagonist, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile

Primary Objective: To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by * Annualized rate of acute moderate or severe COPD exacerbation (AECOPD) Secondary Objectives: To evaluate the effect of dupilumab administered every 2 weeks on * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo * Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ) * Pre-bronchodilator FEV1 over 52 weeks compared to placebo * Lung function assessments * Moderate and severe COPD exacerbations * To evaluate safety and tolerability * To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

Eligibility overview

Sex: ALL

Age: 40 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants with a physician diagnosis of COPD who met the following criteria at screening:

* Current or former smokers with a smoking history of ≥10 pack-years.
* Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity \[FVC\] 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 participant was taking inhaled corticosteroid (ICS)/long-acting beta agonist (LABA)/long-acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations were recorded by the investigator and defined as AECOPD that required either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations had to require the use of systemic corticosteroids. Severe exacerbations were 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: Participants with blood eosinophils ≥300 cells/microliter at Visit 1.

Exclusion Criteria:

* 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 (e.g., 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 Bi-level ventilation.
* AECOPD as defined in inclusion criteria within 4 weeks prior to screening, 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. Participants who were participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation \<4 weeks prior to screening (Note: participants in the maintenance phase of a rehabilitation program can be included).
* Diagnosis of α-1 anti-trypsin deficiency.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (334)

Cullman, Alabama, United States
Jasper, Alabama, United States
Scottsboro, Alabama, United States
Peoria, Arizona, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
Bakersfield, California, United States
Newport Beach, California, United States
Rancho Cucamonga, California, United States
San Diego, California, United States
San Diego, California, United States
Westminster, California, United States
Lafayette, Colorado, United States
Boynton Beach, Florida, United States
Boynton Beach, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Cutler Bay, Florida, United States
DeBary, Florida, United States
Doral, Florida, United States
Fort Lauderdale, Florida, United States
Greenacres City, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
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