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: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Birmingham, Alabama 35209-6802, United States
Colorado Springs, Colorado 80907, United States
Orlando, Florida 32825, United States
Baltimore, Maryland 21224, United States
Ann Arbor, Michigan 48109, United States
Chapel Hill, North Carolina 27514, United States
Durham, North Carolina 27705, United States
Winston-Salem, North Carolina 27103-4027, United States
Clairton, Pennsylvania 15025, United States
Pittsburgh, Pennsylvania 15213, United States
Wyomissing, Pennsylvania 19610, United States
Mt. Pleasant, South Carolina 29464, United States
Franklin, Tennessee 37067, United States
Tacoma, Washington 98405, United States
CABA, Buenos Aires 1430, Argentina
CABA, Buenos Aires C1414AIF, Argentina
CABA, Buenos Aires C1425BEN, Argentina
CABA, Buenos Aires C1425FVH, Argentina
Quilmes, Buenos Aires F.D. B1878FNR, Argentina
St-charles Borrommee, Quebec J6E 2B4, Canada
Jindrichuv Hradec III, 37701, Czechia
Praha 6 - Brevnov, 16900, Czechia
Copenhagen Nv, 2400, Denmark
Gödöllö, 2100, Hungary
Hajdunánás, 4080, Hungary
Kasuga-shi, Fukuoka 816-0813, Japan
Himeji-shi, Hyōgo 670-0849, Japan
Higashiibaraki-gun, Ibaraki 311-3193, Japan
Naka-gun, Ibaraki 319-1113, Japan
Joyo-shi, Kyoto 610-0113, Japan
Ueda-shi, Nagano, Japan
Urasoe-shi, Okinawa 901-2121, Japan
Kawachinagano-shi, Osaka 586-8521, Japan
Kishiwada-shi, Osaka 596-8501, Japan
Sakai-shi, Osaka 591-8555, Japan
Chuo-ku, Tokyo 103-0022, Japan
Chuo-ku, Tokyo 103-0028, Japan
Chuo-ku, Tokyo 104-0031, Japan
Kokubunji-shi, Tokyo 185-0014, Japan
Shinagawa-ku, Tokyo 140-8522, Japan
Toshima-ku, Tokyo 170-0003, Japan
Toshima-ku, Tokyo 1710014, Japan
Elblag, Pomeranian Voivodeship 82-300, Poland
Mérida / Badajoz, Extremadura 06800, Spain