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
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
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
Secondary Objectives:
To evaluate the effect of dupilumab administered every 2 weeks on
Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up
Inclusion Criteria:
Participants with a physician diagnosis of COPD who met the following criteria at screening:
Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/microliter at Visit 1.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Rancho Cucamonga, California 91730, United States
San Diego, California 92120, United States
Cape Coral, Florida 33991, United States
Clearwater, Florida 33765, United States
Cutler Bay, Florida 33157, United States
Orlando, Florida 32825-4454, United States
Plant City, Florida 33563, United States
St. Petersburg, Florida 33704, United States
Fall River, Massachusetts 02723, United States
New Windsor, New York 12553-7754, United States
Mooresville, North Carolina 28117, United States
Mooresville, North Carolina 28117, United States
New Bern, North Carolina 28562, United States
Winston-Salem, North Carolina 27103, United States
Oklahoma City, Oklahoma 73120, United States
Franklin, Tennessee 37067, United States
Houston, Texas 77043-2742, United States
Greenfield, Wisconsin 53228, United States
CABA, Buenos Aires C1122AAK, Argentina
CABA, Buenos Aires C1414AIF, Argentina
CABA, Buenos Aires C1425BEN, Argentina
CABA, Buenos Aires C1425FVH, Argentina
Quilmes, Buenos Aires F.D. B1878FNR, Argentina
Launs Este, B1824KAJ, Argentina
Vitória, Espírito Santo 29055 450, Brazil
Passo Fundo, Rio Grande do Sul 99010-120, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Campinas, São Paulo 13059-900, Brazil
Santo André, São Paulo 09060-870, Brazil
São Paulo, São Paulo 01229-010, Brazil
São Paulo, São Paulo 04014-002, Brazil
São Paulo, São Paulo 05403-900, Brazil
Jindrichuv Hradec III, 37701, Czechia
Palaio Faliro, Athens, 17562, Greece
Gödöllö, 2100, Hungary
Hajdunánás, 4080, Hungary
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship 27-400, Poland
Gauteng, 1935, South Africa