Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation (BOREAS)

January 30, 2024 updated by: Sanofi

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

Annualized rate of acute moderate and 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 anti-drug antibodies (ADA)

Study Overview

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Intervention / Treatment

Detailed Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up.

Study Type

Interventional

Enrollment (Actual)

939

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1121ABE
    - Investigational Site Number :0320001
  - Buenos Aires, Argentina
    - Investigational Site Number :0320005
  - Mar Del Plata, Argentina, B7600
    - Investigational Site Number :0320008
  - Mendoza, Argentina, 5500
    - Investigational Site Number :0320010
- Buenos Aires
  - Caba, Buenos Aires, Argentina, 1430
    - Investigational Site Number :0320011
  - Caba, Buenos Aires, Argentina, C1414AIF
    - Investigational Site Number :0320002
  - Caba, Buenos Aires, Argentina, C1425BEN
    - Investigational Site Number :0320003
  - Caba, Buenos Aires, Argentina, C1425FVH
    - Investigational Site Number :0320004
  - La Plata, Buenos Aires, Argentina, B1900BNN
    - Investigational Site Number :0320012
- Ciudad De Buenos Aires
  - Quilmes, Ciudad De Buenos Aires, Argentina, B1878FNR
    - Investigational Site Number :0320007
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DBS
    - Investigational Site Number :0320006
- Tucumán
  - San Miguel de Tucumán, Tucumán, Argentina, T4000IAR
    - Investigational Site Number :0320009
Bulgaria
- - Haskovo, Bulgaria, 6305
    - Investigational Site Number :1001004
  - Montana, Bulgaria, 3400
    - Investigational Site Number :1001003
  - Ruse, Bulgaria, 7002
    - Investigational Site Number :1001006
  - Sofia, Bulgaria, 1202
    - Investigational Site Number :1001009
  - Sofia, Bulgaria, 1233
    - Investigational Site Number :1001002
  - Sofia, Bulgaria, 1680
    - Investigational Site Number :1001001
  - Stara Zagora, Bulgaria, 6001
    - Investigational Site Number :1001005
  - Troyan, Bulgaria, 5600
    - Investigational Site Number :1001010
Canada
- - Quebec, Canada, G1V 4W2
    - Investigational Site Number :1240004
  - Quebec, Canada, G1V 4G5
    - Investigational Site Number :1240005
  - Quebec, Canada, G3K 2P8
    - Investigational Site Number :1240019
  - Quebec, Canada, GIS 2L6
    - Investigational Site Number :1240018
- Alberta
  - Edmonton, Alberta, Canada, T5H4B9
    - Investigational Site Number :1240021
  - Edmonton, Alberta, Canada, T6G 2G3
    - Investigational Site Number :1240015
  - Sherwood Park, Alberta, Canada, T8H 0N2
    - Investigational Site Number :1240016
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Investigational Site Number :1240017
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Investigational Site Number :1240007
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - Investigational Site Number :1240002
  - Toronto, Ontario, Canada, M5T 3A9
    - Investigational Site Number :1240012
  - Windsor, Ontario, Canada, N8X 5A6
    - Investigational Site Number :1240013
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - Investigational Site Number :1240001
  - Montreal, Quebec, Canada, H1M 1B1
    - Investigational Site Number :1240009
  - Montreal, Quebec, Canada, H1T 1C8
    - Investigational Site Number :1240003
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Investigational Site Number :1240010
  - Sherbrooke, Quebec, Canada, J1L 0H8
    - Investigational Site Number :1240011
  - St-charles Borrommee, Quebec, Canada, J6E 2B4
    - Investigational Site Number :1240006
  - Trois-Rivieres, Quebec, Canada, G8T 7A1
    - Investigational Site Number :1240008
  - Victoriaville, Quebec, Canada, G6P 6P6
    - Investigational Site Number :1240020
Chile
- Maule
  - Curicó, Maule, Chile, 3341643
    - Investigational Site Number :1520006
  - Talca, Maule, Chile
    - Investigational Site Number :1520001
- Reg Metropolitana De Santiago
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500587
    - Investigational Site Number :1520009
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500692
    - Investigational Site Number :1520003
  - Santiago, Reg Metropolitana De Santiago, Chile, 7500698
    - Investigational Site Number :1520005
  - Santiago, Reg Metropolitana De Santiago, Chile, 8380453
    - Investigational Site Number :1520008
  - Santiago, Reg Metropolitana De Santiago, Chile, 8910131
    - Investigational Site Number :1520002
- Valparaíso
  - Quillota, Valparaíso, Chile, 2260877
    - Investigational Site Number :1520004
China
- - Baotou, China, 014010
    - Investigational Site Number :1560037
  - Beijing, China
    - Investigational Site Number :1560006
  - Changchun, China, 130021
    - Investigational Site Number :1560003
  - Changsha, China, 410011
    - Investigational Site Number :1560022
  - Changsha, China, 410013
    - Investigational Site Number :1560021
  - Chengdu, China, 610041
    - Investigational Site Number :1560001
  - Chengdu, China, 611130
    - Investigational Site Number :1560017
  - Chongqing, China, 400037
    - Investigational Site Number :1560012
  - Chongqing, China, 400038
    - Investigational Site Number :1560005
  - Fuzhou, China, 350001
    - Investigational Site Number :1560053
  - Guangzhou, China, 510150
    - Investigational Site Number :1560036
  - Guangzhou, China, 510163
    - Investigational Site Number :1560019
  - Haikou, China, 570216
    - Investigational Site Number :1560045
  - Haikou, China, 570311
    - Investigational Site Number :1560018
  - Hangzhou, China, 310009
    - Investigational Site Number :1560046
  - Hefei, China, 230022
    - Investigational Site Number :1560009
  - Hefei, China
    - Investigational Site Number :1560041
  - Hohhot, China, 010017
    - Investigational Site Number :1560015
  - Hohhot, China, 010050
    - Investigational Site Number :1560008
  - Nanchang, China, 330006
    - Investigational Site Number :1560027
  - Nanjing, China, 210009
    - Investigational Site Number :1560034
  - Shanghai, China, 200025
    - Investigational Site Number :1560032
  - Shanghai, China, 200080
    - Investigational Site Number :1560013
  - Shanghai, China, 200433
    - Investigational Site Number :1560007
  - Shenyang, China, 110001
    - Investigational Site Number :1560014
  - Shenyang, China, 110004
    - Investigational Site Number :1560004
  - Shenzhen, China, 518020
    - Investigational Site Number :1560051
  - Shijiazhuang, China, 050000
    - Investigational Site Number :1560016
  - Taiyuan, China, 030001
    - Investigational Site Number :1560024
  - Tianjin, China, 300052
    - Investigational Site Number :1560010
  - Urumchi, China, 830054
    - Investigational Site Number :1560028
  - Wuhan, China, 430014
    - Investigational Site Number :1560052
  - Xi'An, China, 710061
    - Investigational Site Number :1560020
  - Xuzhou, China, 221002
    - Investigational Site Number :1560054
  - Yangzhou, China, 225001
    - Investigational Site Number :1560011
  - Zhanjiang, China, 524001
    - Investigational Site Number :1560031
  - Zhengzhou, China, 450003
    - Investigational Site Number :1560002
Czechia
- - Jindrichuv Hradec III, Czechia, 37701
    - Investigational Site Number :2030002
  - Karlovy Vary, Czechia, 36017
    - Investigational Site Number :2030005
  - Miroslav, Czechia, 67172
    - Investigational Site Number :2030009
  - Novy Bor, Czechia, 47301
    - Investigational Site Number :2030001
  - Praha 4, Czechia, 14059
    - Investigational Site Number :2030003
  - Praha 6 - Brevnov, Czechia, 16900
    - Investigational Site Number :2030008
  - Rokycany, Czechia, 33722
    - Investigational Site Number :2030004
  - Strakonice, Czechia, 38601
    - Investigational Site Number :2030006
Denmark
- - Copenhagen Nv, Denmark, 2400
    - Investigational Site Number :2080001
  - Hvidovre, Denmark, 2650
    - Investigational Site Number :2080002
  - Naestved, Denmark, 4700
    - Investigational Site Number :2080006
  - Odense C, Denmark, 5000
    - Investigational Site Number :2080005
  - Roskilde, Denmark, 4000
    - Investigational Site Number :2080004
  - Vejle, Denmark, 7100
    - Investigational Site Number :2080007
  - Ålborg, Denmark, 9100
    - Investigational Site Number :2080003
Finland
- - Pori, Finland, 28500
    - Investigational Site Number :2460003
  - Turku, Finland, 20520
    - Investigational Site Number :2460001
Germany
- - Berlin, Germany, 10787
    - Investigational Site Number :2760006
  - Frankfurt am Main, Germany, 60596
    - Investigational Site Number :2760009
  - Hamburg, Germany, 20354
    - Investigational Site Number :2760002
  - Koblenz, Germany, 56068
    - Investigational Site Number :2760007
  - Leipzig, Germany, 04347
    - Investigational Site Number :2760011
  - Lübeck, Germany, 23552
    - Investigational Site Number :2760010
  - Marburg, Germany, 35043
    - Investigational Site Number :2760008
Hungary
- - Balassagyarmat, Hungary, 2660
    - Investigational Site Number :3480007
  - Budapest, Hungary, 1122
    - Investigational Site Number :3480011
  - Edelény, Hungary, 3780
    - Investigational Site Number :3480008
  - Gödöllö, Hungary, 2100
    - Investigational Site Number :3480001
  - Hajdunánás, Hungary, 4080
    - Investigational Site Number :3480010
  - Komarom, Hungary, 2900
    - Investigational Site Number :3480002
  - Makó, Hungary, 6900
    - Investigational Site Number :3480003
  - Mohács, Hungary, 7700
    - Investigational Site Number :3480006
  - Puspokladany, Hungary, 4150
    - Investigational Site Number :3480012
  - Szombathely, Hungary, 9700
    - Investigational Site Number :3480005
  - Százhalombatta, Hungary, 2440
    - Investigational Site Number :3480004
Israel
- - Ashkelon, Israel, 78278
    - Investigational Site Number :3760006
  - Beer Sheva, Israel, 84101
    - Investigational Site Number :3760007
  - Haifa, Israel, 34362
    - Investigational Site Number :3760003
  - Jerusalem, Israel, 91031
    - Investigational Site Number :3760005
  - Jerusalem, Israel, 91120
    - Investigational Site Number :3760004
  - Petah-Tikva, Israel, 49100
    - Investigational Site Number :3760001
  - Rehovot, Israel, 76100
    - Investigational Site Number :3760002
Italy
- - Pisa, Italy, 56124
    - Investigational Site Number :3800007
  - Reggio Emilia, Italy, 42123
    - Investigational Site Number :3800001
  - Roma, Italy, 00133
    - Investigational Site Number :3800005
- Ferrara
  - Cona, Ferrara, Italy, 44124
    - Investigational Site Number :3800004
- Milano
  - Rozzano, Milano, Italy, 20089
    - Investigational Site Number :3800003
Japan
- Fukuoka
  - Kasuga-shi, Fukuoka, Japan, 816-0813
    - Investigational Site Number :3920013
- Hyogo
  - Himeji-shi, Hyogo, Japan, 670-0849
    - Investigational Site Number :3920011
- Ibaraki
  - Higashiibaraki-gun, Ibaraki, Japan, 311-3193
    - Investigational Site Number :3920023
  - Naka-gun, Ibaraki, Japan, 319-1113
    - Investigational Site Number :3920014
- Kagawa
  - Takamatsu-shi, Kagawa, Japan, 761-8073
    - Investigational Site Number :3920019
- Kanagawa
  - Yokohama-shi, Kanagawa, Japan, 223-0059
    - Investigational Site Number :3920027
- Kyoto
  - Joyo-shi, Kyoto, Japan, 610-0113
    - Investigational Site Number :3920003
  - Kyoto-shi, Kyoto, Japan, 612-8555
    - Investigational Site Number :3920017
- Nagano
  - Ueda-shi, Nagano, Japan
    - Investigational Site Number :3920006
- Okinawa
  - Urasoe-shi, Okinawa, Japan, 901-2121
    - Investigational Site Number :3920029
- Osaka
  - Kawachinagano-shi, Osaka, Japan, 586-8521
    - Investigational Site Number :3920018
  - Kishiwada-shi, Osaka, Japan, 596-8501
    - Investigational Site Number :3920001
  - Osaka-shi, Osaka, Japan, 531-0073
    - Investigational Site Number :3920028
  - Sakai-shi, Osaka, Japan, 591-8555
    - Investigational Site Number :3920012
- Shizuoka
  - Hamamatsu-shi, Shizuoka, Japan, 434-8511
    - Investigational Site Number :3920021
- Tokyo
  - Chuo-ku, Tokyo, Japan, 103-0022
    - Investigational Site Number :3920008
  - Chuo-ku, Tokyo, Japan, 103-0028
    - Investigational Site Number :3920030
  - Chuo-ku, Tokyo, Japan, 104-0031
    - Investigational Site Number :3920005
  - Kokubunji-shi, Tokyo, Japan, 185-0014
    - Investigational Site Number :3920015
  - Shinagawa-ku, Tokyo, Japan, 140-8522
    - Investigational Site Number :3920016
  - Toshima-ku, Tokyo, Japan, 170-0003
    - Investigational Site Number :3920004
  - Toshima-ku, Tokyo, Japan, 1710014
    - Investigational Site Number :3920026
Korea, Republic of
- Gangwon-do
  - Wonju, Gangwon-do, Korea, Republic of, 26426
    - Investigational Site Number :4100003
- Gyeonggi-do
  - Seongnam, Gyeonggi-do, Korea, Republic of, 13620
    - Investigational Site Number :4100004
- Incheon-gwangyeoksi
  - Incheon, Incheon-gwangyeoksi, Korea, Republic of, 21431
    - Investigational Site Number :4100008
- Seoul-teukbyeolsi
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03080
    - Investigational Site Number :4100001
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 03312
    - Investigational Site Number :4100009
  - Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05505
    - Investigational Site Number :4100007
Mexico
- - Chihuahua, Mexico, 31000
    - Investigational Site Number :4840004
  - Durango, Mexico, 34080
    - Investigational Site Number :4840003
  - Mexico Distrito Federal, Mexico, 06700
    - Investigational Site Number :4840006
  - Oaxaca, Mexico, 68000
    - Investigational Site Number :4840007
  - Veracruz, Mexico, 91910
    - Investigational Site Number :4840005
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44100
    - Investigational Site Number :4840002
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Investigational Site Number :4840001
Poland
- Kujawsko-pomorskie
  - Grudziadz, Kujawsko-pomorskie, Poland, 86-300
    - Investigational Site Number :6160009
- Malopolskie
  - Krakow, Malopolskie, Poland, 31-559
    - Investigational Site Number :6160007
- Mazowieckie
  - Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
    - Investigational Site Number :6160015
  - Warszawa, Mazowieckie, Poland, 01-456
    - Investigational Site Number :6160012
- Podlaskie
  - Bialystok, Podlaskie, Poland, 15-044
    - Investigational Site Number :6160008
- Pomorskie
  - Elblag, Pomorskie, Poland, 82-300
    - Investigational Site Number :6160014
- Slaskie
  - Katowice, Slaskie, Poland, 40-648
    - Investigational Site Number :6160011
- Wielkopolskie
  - Poznan, Wielkopolskie, Poland, 60-214
    - Investigational Site Number :6160016
  - Poznan, Wielkopolskie, Poland, 61-578
    - Investigational Site Number :6160006
Romania
- - Bucharest, Romania, 011461
    - Investigational Site Number :6420001
  - Bucuresti, Romania, 030303
    - Investigational Site Number :6420009
  - Bucuresti, Romania, 050159
    - Investigational Site Number :6420008
  - Cluj-Napoca, Romania, 400371
    - Investigational Site Number :6420003
  - Cluj-Napoca, Romania, 400371
    - Investigational Site Number :6420004
  - Constanta, Romania, 900002
    - Investigational Site Number :6420007
  - Timisoara, Romania, 300310
    - Investigational Site Number :6420006
  - Timisoara, Romania, 300310
    - Investigational Site Number :6420010
Russian Federation
- - Chelyabinsk, Russian Federation, 454091
    - Investigational Site Number :6430003
  - Kazan, Russian Federation, 420008
    - Investigational Site Number :6430004
  - Moscow, Russian Federation, 105077
    - Investigational Site Number :6430006
  - Moscow, Russian Federation, 115093
    - Investigational Site Number :6430001
  - Moscow, Russian Federation, 115280
    - Investigational Site Number :6430005
  - Moscow, Russian Federation, 115682
    - Investigational Site Number :6430008
  - Moscow, Russian Federation, 117546
    - Investigational Site Number :6430002
  - Moscow, Russian Federation, 125284
    - Investigational Site Number :6430009
  - St-Petersburg, Russian Federation, 193231
    - Investigational Site Number :6430007
Slovakia
- - Banska Bystrica, Slovakia, 97517
    - Investigational Site Number :7030007
  - Humenne, Slovakia, 066 01
    - Investigational Site Number :7030006
  - Levice, Slovakia, 93401
    - Investigational Site Number :7030003
  - Poprad, Slovakia, 058 01
    - Investigational Site Number :7030001
  - Spisska Nova Ves, Slovakia, 05201
    - Investigational Site Number :7030002
Spain
- - Madrid, Spain, 28007
    - Investigational Site Number :7240003
  - Málaga, Spain, 29010
    - Investigational Site Number :7240001
  - Palma de Mallorca, Spain, 07120
    - Investigational Site Number :7240010
  - Valencia, Spain, 46015
    - Investigational Site Number :7240004
- A Coruña [La Coruña]
  - Santiago de Compostela, A Coruña [La Coruña], Spain, 15706
    - Investigational Site Number :7240096
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spain, 08035
    - Investigational Site Number :7240002
  - Sant Boi de Llobregat, Barcelona [Barcelona], Spain, 08830
    - Investigational Site Number :7240007
- Extremadura
  - Mérida / Badajoz, Extremadura, Spain, 06800
    - Investigational Site Number :7240005
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Investigational Site Number :7240006
Sweden
- - Lund, Sweden, 221 85
    - Investigational Site Number :7520001
  - Stockholm, Sweden, 114 46
    - Investigational Site Number :7520002
Turkey
- - Ankara, Turkey, 06100
    - Investigational Site Number :7920004
  - Istanbul, Turkey, 34098
    - Investigational Site Number :7920001
  - Izmir, Turkey, 35040
    - Investigational Site Number :7920006
  - Izmir, Turkey, 35110
    - Investigational Site Number :7920007
  - Kirikkale, Turkey, 71450
    - Investigational Site Number :7920008
  - Manisa, Turkey, 45000
    - Investigational Site Number :7920005
  - Mersin, Turkey, 33070
    - Investigational Site Number :7920002
Ukraine
- - Chernivtsi, Ukraine, 58001
    - Investigational Site Number :8040003
  - Ivano-Frankivsk, Ukraine, 76018
    - Investigational Site Number :8040001
  - Kharkiv, Ukraine, 61166
    - Investigational Site Number :8040006
  - Kyiv, Ukraine, 02125
    - Investigational Site Number :8040004
  - Odesa, Ukraine, 65025
    - Investigational Site Number :8040009
  - Ternopil, Ukraine, 46000
    - Investigational Site Number :8040002
  - Vinnytsya, Ukraine, 21001
    - Investigational Site Number :8040005
  - Zhytomyr, Ukraine, 10002
    - Investigational Site Number :8040007
United States
- Alabama
  - Andalusia, Alabama, United States, 36420
    - SEC Clinical Research, LLC-Site Number:8400030
  - Birmingham, Alabama, United States, 35209-6802
    - Clinical Research Center of Alabama, LLC-Site Number:8400041
  - Birmingham, Alabama, United States, 35294
    - UAB Lung Health Center-Site Number:8400013
  - Dothan, Alabama, United States, 36303
    - SEC Clinical Research, LLC-Site Number:8400059
  - Mobile, Alabama, United States, 36608
    - Pulmonary Associates of Mobile, P.C.-Site Number:8400057
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Asthma and Allergy Associates, PC-Site Number:8400034
- Florida
  - Clearwater, Florida, United States, 33765
    - Clinical Research Of West Florida Inc-Site Number:8400010
  - Greenacres City, Florida, United States, 33467
    - Finlay Medical Research-Site Number:8400014
  - Miami, Florida, United States, 33125
    - Project 4 research, Inc.-Site Number:8400023
  - Miami, Florida, United States, 33126
    - Finlay Medical Research-Site Number:8400062
  - Ocala, Florida, United States, 34470
    - Renstar Medical Research-Site Number:8400051
  - Orlando, Florida, United States, 32825
    - Florida Institute for Clinical Research, LLC-Site Number:8400029
  - Panama City, Florida, United States, 32405
    - Emerald Coast Research Associates-Site Number:8400032
  - Sarasota, Florida, United States, 34239
    - Sarasota Clinical Research-Site Number:8400026
- Georgia
  - Dacula, Georgia, United States, 30019
    - VitaLink research-Hamilton Mill-Site Number:8400055
  - Marietta, Georgia, United States, 30060
    - DC Research Works-Site Number:8400016
  - Woodstock, Georgia, United States, 30189
    - North Georgia Clinical Research-Site Number:8400025
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012
  - White Marsh, Maryland, United States, 21162
    - Asthma Allergy & Sinus Center-Site Number:8400038
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Michigan Medicine (University of Michigan)-Site Number:8400050
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Lanmark Center 2-46-Site Number:8400065
- Missouri
  - Saint Charles, Missouri, United States, 63301
    - Midwest Chest Consultants, P.C.-Site Number:8400011
  - Saint Louis, Missouri, United States, 63104
    - Washington University School of Medicine-Site Number:8400004
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Sierra Clinical Research-Site Number:8400035
- New York
  - Buffalo, New York, United States, 14215
    - Va Western New York Healthcare-Site Number:8400067
  - New York, New York, United States, 10036
    - IMA Clinical Research, LLC-Site Number:8400070
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019
  - Charlotte, North Carolina, United States, 28277
    - American Health Research-Site Number:8400061
  - Durham, North Carolina, United States, 27705
    - Duke Asthma, Allergy and Airway Center-Site Number:8400064
  - Wilmington, North Carolina, United States, 28401
    - Accellacare-Site Number:8400052
  - Winston-Salem, North Carolina, United States, 27103-4027
    - Southeastern Research Center-Site Number:8400060
- Ohio
  - Dayton, Ohio, United States, 45459
    - Midwest Pulmonary and Sleep Research Center-Site Number:8400040
  - Dublin, Ohio, United States, 43016
    - Aventiv Research, Inc-Site Number:8400024
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - OK Clinical Research-Site Number:8400005
- Oregon
  - Medford, Oregon, United States, 97504
    - Velocity Clinical Research, Medford-Site Number:8400001
- Pennsylvania
  - Clairton, Pennsylvania, United States, 15025
    - Jefferson Associates in Internal Medicine-Site Number:8400037
  - Philadelphia, Pennsylvania, United States, 19140
    - Temple University Hospital-Site Number:8400009
  - Pittsburgh, Pennsylvania, United States, 15213
    - Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033
  - Wyomissing, Pennsylvania, United States, 19610
    - Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063
- South Carolina
  - Easley, South Carolina, United States, 29640
    - VitaLink Research-Easley-Site Number:8400022
  - Gaffney, South Carolina, United States, 29340
    - VitaLink Research- Gaffney-Site Number:8400047
  - Greenville, South Carolina, United States, 29615
    - VitaLink Research-Greenville-Site Number:8400007
  - Mount Pleasant, South Carolina, United States, 29464
    - Clinical Research of Charleston-Site Number:8400044
  - Rock Hill, South Carolina, United States, 29732
    - Clinical Research of Rock Hill-Site Number:8400046
  - Spartanburg, South Carolina, United States, 29303
    - VitaLink Research - Spartanburg-Site Number:8400048
- Tennessee
  - Franklin, Tennessee, United States, 37067
    - Clinical Trials Center of Middle Tennessee-Site Number:8400073
- Texas
  - Houston, Texas, United States, 77030
    - Bayer College of Medicine-Site Number:8400018
  - McKinney, Texas, United States, 75069
    - Metroplex Pulmonary and Sleep Center-Site Number:8400021
  - Sherman, Texas, United States, 75092
    - Sherman Clinical Research-Site Number:8400027
- Washington
  - Tacoma, Washington, United States, 98405
    - MultiCare Institute for Research and Innovation-Site Number:8400036
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 patient 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 acute exacerbation of COPD (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 was contraindicated.
Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.

Exclusion criteria:

COPD diagnosis for less than 12 months prior to randomization.
A current diagnosis of asthma or history of asthma according to the 2018 Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
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.
Treatment with oxygen of more than 12 hours per day.
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. Patients who were 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 could be included).
Diagnosis of α-1 anti-trypsin deficiency.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).	Drug: Dupilumab SAR231893 Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Other Names: Dupixent Drug: Inhaled Corticosteroid Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Beta Agonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Muscarinic Antagonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
Placebo Comparator: Placebo Participants received placebo matched to dupilumab 300 mg as subcutaneous (SC) injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, end of treatment [EOT] visit occurred 2 weeks after last administration of treatment i.e., at Week 52).	Drug: Inhaled Corticosteroid Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Beta Agonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Inhaled Long-Acting Muscarinic Antagonist Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation Drug: Placebo Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Participant Group / Arm

Intervention / Treatment

Experimental: Dupilumab

Participants received dupilumab 300 mg administered as SC injections q2w up to a maximum of 52 weeks (last dose administered at Week 50, EOT visit occurred 2 weeks after last administration of treatment i.e., at Week 52).

Drug: Dupilumab SAR231893

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Other Names:

Dupixent

Drug: Inhaled Corticosteroid

Pharmaceutical form: Inhaled Powder