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

PHASE3CompletedINTERVENTIONAL
Enrollment

939

Participants

Timeline

Start Date

April 15, 2019

Primary Completion Date

February 8, 2023

Study Completion Date

May 2, 2023

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Dupilumab SAR231893

"Pharmaceutical form: Solution for injection~Route of administration: Subcutaneous"

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"

Trial Locations (275)

1122

Investigational Site Number :3480011, Budapest

1202

Investigational Site Number :1001009, Sofia

1233

Investigational Site Number :1001002, Sofia

1430

Investigational Site Number :0320011, CABA

1680

Investigational Site Number :1001001, Sofia

2100

Investigational Site Number :3480001, Gödöllö

2400

Investigational Site Number :2080001, Copenhagen Nv

2440

Investigational Site Number :3480004, Százhalombatta

2650

Investigational Site Number :2080002, Hvidovre

2660

Investigational Site Number :3480007, Balassagyarmat

2900

Investigational Site Number :3480002, Komárom

3400

Investigational Site Number :1001003, Montana

3780

Investigational Site Number :3480008, Edelény

4000

Investigational Site Number :2080004, Roskilde

4080

Investigational Site Number :3480010, Hajdunánás

4150

Investigational Site Number :3480012, Püspökladány

4700

Investigational Site Number :2080006, Næstved

5000

Investigational Site Number :2080005, Odense C

5500

Investigational Site Number :0320010, Mendoza

5600

Investigational Site Number :1001010, Troyan Municipality

6001

Investigational Site Number :1001005, Stara Zagora

6305

Investigational Site Number :1001004, Haskovo

6900

Investigational Site Number :3480003, Makó

7002

Investigational Site Number :1001006, Rousse

7100

Investigational Site Number :2080007, Vejle

7700

Investigational Site Number :3480006, Mohács

9100

Investigational Site Number :2080003, Aalborg

9700

Investigational Site Number :3480005, Szombathely

10002

Investigational Site Number :8040007, Zhytomyr

10036

IMA Clinical Research, LLC-Site Number:8400070, New York

10787

Investigational Site Number :2760006, Berlin

13620

Investigational Site Number :4100004, Seongnam-si

14059

Investigational Site Number :2030003, Prague

14215

Va Western New York Healthcare-Site Number:8400067, Buffalo

15025

Jefferson Associates in Internal Medicine-Site Number:8400037, Clairton

15213

Emphysema COPD Research Center, Kaufmann Medical Building-Site Number:8400033, Pittsburgh

15706

Investigational Site Number :7240096, Santiago de Compostela

16900

Investigational Site Number :2030008, Praha 6 - Brevnov

19140

Temple University Hospital-Site Number:8400009, Philadelphia

19610

Berks Schuylkill Respiratory Specialists, LTD-Site Number:8400063, Wyomissing

20089

Investigational Site Number :3800003, Rozzano

20354

Investigational Site Number :2760002, Hamburg

20520

Investigational Site Number :2460001, Turku

21001

Investigational Site Number :8040005, Vinnytsia

21162

Asthma Allergy & Sinus Center-Site Number:8400038, White Marsh

21224

Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400012, Baltimore

21431

Investigational Site Number :4100008, Incheon

23552

Investigational Site Number :2760010, Lübeck

26426

Investigational Site Number :4100003, Wŏnju

27514

The University of North Carolina at Chapel Hill - Division of Pulmonary and Critical Care Medicine-Site Number:8400019, Chapel Hill

27705

Duke Asthma, Allergy and Airway Center-Site Number:8400064, Durham

28007

Investigational Site Number :7240003, Madrid

28223

Investigational Site Number :7240006, Pozuelo de Alarcón

28277

American Health Research-Site Number:8400061, Charlotte

28401

Accellacare-Site Number:8400052, Wilmington

28500

Investigational Site Number :2460003, Pori

29010

Investigational Site Number :7240001, Málaga

29303

VitaLink Research - Spartanburg-Site Number:8400048, Spartanburg

29340

VitaLink Research- Gaffney-Site Number:8400047, Gaffney

29464

Clinical Research of Charleston-Site Number:8400044, Mt. Pleasant

29615

VitaLink Research-Greenville-Site Number:8400007, Greenville

29640

VitaLink Research-Easley-Site Number:8400022, Easley

29732

Clinical Research of Rock Hill-Site Number:8400046, Rock Hill

30019

VitaLink research-Hamilton Mill-Site Number:8400055, Dacula

30060

DC Research Works-Site Number:8400016, Marietta

30189

North Georgia Clinical Research-Site Number:8400025, Woodstock

31000

Investigational Site Number :4840004, Chihuahua City

32405

Emerald Coast Research Associates-Site Number:8400032, Panama City

32825

Florida Institute for Clinical Research, LLC-Site Number:8400029, Orlando

33070

Investigational Site Number :7920002, Mersin

33125

Project 4 research, Inc.-Site Number:8400023, Miami

33126

Finlay Medical Research-Site Number:8400062, Miami

33467

Finlay Medical Research-Site Number:8400014, Greenacres City

33722

Investigational Site Number :2030004, Rokycany

33765

Clinical Research Of West Florida Inc-Site Number:8400010, Clearwater

34080

Investigational Site Number :4840003, Durango

34098

Investigational Site Number :7920001, Istanbul

34239

Sarasota Clinical Research-Site Number:8400026, Sarasota

34362

Investigational Site Number :3760003, Haifa

34470

Renstar Medical Research-Site Number:8400051, Ocala

35040

Investigational Site Number :7920006, Izmir

35043

Investigational Site Number :2760008, Marburg

35110

Investigational Site Number :7920007, Izmir

35294

UAB Lung Health Center-Site Number:8400013, Birmingham

36017

Investigational Site Number :2030005, Karlovy Vary

36303

SEC Clinical Research, LLC-Site Number:8400059, Dothan

36420

SEC Clinical Research, LLC-Site Number:8400030, Andalusia

36608

Pulmonary Associates of Mobile, P.C.-Site Number:8400057, Mobile

37067

Clinical Trials Center of Middle Tennessee-Site Number:8400073, Franklin

37701

Investigational Site Number :2030002, Jindrichuv Hradec III

38601

Investigational Site Number :2030006, Strakonice

42123

Investigational Site Number :3800001, Reggio Emilia

43016

Aventiv Research, Inc-Site Number:8400024, Dublin

44100

Investigational Site Number :4840002, Guadalajara

44124

Investigational Site Number :3800004, Cona

45000

Investigational Site Number :7920005, Manisa

45459

Midwest Pulmonary and Sleep Research Center-Site Number:8400040, Dayton

46000

Investigational Site Number :8040002, Ternopil

46015

Investigational Site Number :7240004, Valencia

47301

Investigational Site Number :2030001, Nový Bor

48109

Michigan Medicine (University of Michigan)-Site Number:8400050, Ann Arbor

49100

Investigational Site Number :3760001, Petah Tikva

53228

Allergy, Asthma & Sinus Center, S.C.-Site Number:8400008, Greenfield

55905

Mayo Clinic Lanmark Center 2-46-Site Number:8400065, Rochester

56068

Investigational Site Number :2760007, Koblenz

56124

Investigational Site Number :3800007, Pisa

58001

Investigational Site Number :8040003, Chernivtsi

60596

Investigational Site Number :2760009, Frankfurt am Main

61166

Investigational Site Number :8040006, Kharkiv

63104

Washington University School of Medicine-Site Number:8400004, St Louis

63301

Midwest Chest Consultants, P.C.-Site Number:8400011, Saint Charles

64460

Investigational Site Number :4840001, Monterrey

65025

Investigational Site Number :8040009, Odesa

67172

Investigational Site Number :2030009, Miroslav

68000

Investigational Site Number :4840007, Oaxaca City

71450

Investigational Site Number :7920008, Kırıkkale

73034

OK Clinical Research-Site Number:8400005, Edmond

75069

Metroplex Pulmonary and Sleep Center-Site Number:8400021, McKinney

75092

Sherman Clinical Research-Site Number:8400027, Sherman

76018

Investigational Site Number :8040001, Ivano-Frankivsk

76100

Investigational Site Number :3760002, Rehovot

77030

Bayer College of Medicine-Site Number:8400018, Houston

78278

Investigational Site Number :3760006, Ashkelon

80907

Asthma and Allergy Associates, PC-Site Number:8400034, Colorado Springs

84101

Investigational Site Number :3760007, Beersheba

89106

Sierra Clinical Research-Site Number:8400035, Las Vegas

91031

Investigational Site Number :3760005, Jerusalem

91120

Investigational Site Number :3760004, Jerusalem

91910

Investigational Site Number :4840005, Veracruz

93401

Investigational Site Number :7030003, Levice

97504

Velocity Clinical Research, Medford-Site Number:8400001, Medford

97517

Investigational Site Number :7030007, Banská Bystrica

98405

MultiCare Institute for Research and Innovation-Site Number:8400036, Tacoma

105077

Investigational Site Number :6430006, Moscow

110001

Investigational Site Number :1560014, Shenyang

110004

Investigational Site Number :1560004, Shenyang

115093

Investigational Site Number :6430001, Moscow

115280

Investigational Site Number :6430005, Moscow

115682

Investigational Site Number :6430008, Moscow

117546

Investigational Site Number :6430002, Moscow

125284

Investigational Site Number :6430009, Moscow

130021

Investigational Site Number :1560003, Changchun

193231

Investigational Site Number :6430007, Saint Petersburg

200025

Investigational Site Number :1560032, Shanghai

200080

Investigational Site Number :1560013, Shanghai

200433

Investigational Site Number :1560007, Shanghai

210009

Investigational Site Number :1560034, Nanjing

221002

Investigational Site Number :1560054, Xuzhou

225001

Investigational Site Number :1560011, Yangzhou

230022

Investigational Site Number :1560009, Hefei

300052

Investigational Site Number :1560010, Tianjin

300310

Investigational Site Number :6420006, Timișoara

Investigational Site Number :6420010, Timișoara

310009

Investigational Site Number :1560046, Hangzhou

330006

Investigational Site Number :1560027, Nanchang

350001

Investigational Site Number :1560053, Fuzhou

400037

Investigational Site Number :1560012, Chongqing

400038

Investigational Site Number :1560005, Chongqing

400371

Investigational Site Number :6420003, Cluj-Napoca

Investigational Site Number :6420004, Cluj-Napoca

410011

Investigational Site Number :1560022, Changsha

410013

Investigational Site Number :1560021, Changsha

420008

Investigational Site Number :6430004, Kazan'

430014

Investigational Site Number :1560052, Wuhan

450003

Investigational Site Number :1560002, Zhengzhou

454091

Investigational Site Number :6430003, Chelyabinsk

510150

Investigational Site Number :1560036, Guangzhou

510163

Investigational Site Number :1560019, Guangzhou

518020

Investigational Site Number :1560051, Shenzhen

524001

Investigational Site Number :1560031, Zhanjiang

570216

Investigational Site Number :1560045, Haikou

570311

Investigational Site Number :1560018, Haikou

610041

Investigational Site Number :1560001, Chengdu

611130

Investigational Site Number :1560017, Chengdu

710061

Investigational Site Number :1560020, Xi'an

830054

Investigational Site Number :1560028, Ürümqi

900002

Investigational Site Number :6420007, Constanța

1710014

Investigational Site Number :3920026, Toshima-ku

2260877

Investigational Site Number :1520004, Quillota

3341643

Investigational Site Number :1520006, Curicó

7500587

Investigational Site Number :1520009, Santiago

7500692

Investigational Site Number :1520003, Santiago

7500698

Investigational Site Number :1520005, Santiago

8380453

Investigational Site Number :1520008, Santiago

8910131

Investigational Site Number :1520002, Santiago

35209-6802

Clinical Research Center of Alabama, LLC-Site Number:8400041, Birmingham

27103-4027

Southeastern Research Center-Site Number:8400060, Winston-Salem

C1414AIF

Investigational Site Number :0320002, CABA

C1425BEN

Investigational Site Number :0320003, CABA

C1425FVH

Investigational Site Number :0320004, CABA

B1900BNN

Investigational Site Number :0320012, La Plata

B1878FNR

Investigational Site Number :0320007, Quilmes

S2000DBS

Investigational Site Number :0320006, Rosario

T4000IAR

Investigational Site Number :0320009, San Miguel de Tucumán

C1121ABE

Investigational Site Number :0320001, Buenos Aires

Unknown

Investigational Site Number :0320005, Buenos Aires

Investigational Site Number :1520001, Talca

Investigational Site Number :1560006, Beijing

Investigational Site Number :1560041, Hefei

Investigational Site Number :3920006, Ueda-shi

B7600

Investigational Site Number :0320008, Mar del Plata

T5H4B9

Investigational Site Number :1240021, Edmonton

T6G 2G3

Investigational Site Number :1240015, Edmonton

T8H 0N2

Investigational Site Number :1240016, Sherwood Park

V5Z 1M9

Investigational Site Number :1240017, Vancouver

V6Z 1Y6

Investigational Site Number :1240007, Vancouver

L7N 3V2

Investigational Site Number :1240002, Burlington

M5T 3A9

Investigational Site Number :1240012, Toronto

N8X 5A6

Investigational Site Number :1240013, Windsor

H1M 1B1

Investigational Site Number :1240009, Montreal

H1T 1C8

Investigational Site Number :1240003, Montreal

H4A 3J1

Investigational Site Number :1240001, Montreal

J1H 5N4

Investigational Site Number :1240010, Sherbrooke

J1L 0H8

Investigational Site Number :1240011, Sherbrooke

J6E 2B4

Investigational Site Number :1240006, St-charles Borrommee

G8T 7A1

Investigational Site Number :1240008, Trois-Rivières

G6P 6P6

Investigational Site Number :1240020, Victoriaville

G1V 4G5

Investigational Site Number :1240005, Québec

G1V 4W2

Investigational Site Number :1240004, Québec

G3K 2P8

Investigational Site Number :1240019, Québec

GIS 2L6

Investigational Site Number :1240018, Québec

014010

Investigational Site Number :1560037, Baotou

010017

Investigational Site Number :1560015, Hohhot

010050

Investigational Site Number :1560008, Hohhot

050000

Investigational Site Number :1560016, Shijiazhuang

030001

Investigational Site Number :1560024, Taiyuan

04347

Investigational Site Number :2760011, Leipzig

00133

Investigational Site Number :3800005, Roma

816-0813

Investigational Site Number :3920013, Kasuga-shi

670-0849

Investigational Site Number :3920011, Himeji-shi

311-3193

Investigational Site Number :3920023, Higashiibaraki-gun

319-1113

Investigational Site Number :3920014, Naka-gun

761-8073

Investigational Site Number :3920019, Takamatsu

223-0059

Investigational Site Number :3920027, Yokohama

610-0113

Investigational Site Number :3920003, Joyo-shi

612-8555

Investigational Site Number :3920017, Kyoto

901-2121

Investigational Site Number :3920029, Urasoe-shi

586-8521

Investigational Site Number :3920018, Kawachinagano-shi

596-8501

Investigational Site Number :3920001, Kishiwada-shi

531-0073

Investigational Site Number :3920028, Osaka

591-8555

Investigational Site Number :3920012, Sakai-shi

434-8511

Investigational Site Number :3920021, Hamamatsu

103-0022

Investigational Site Number :3920008, Chuo-ku

103-0028

Investigational Site Number :3920030, Chuo-ku

104-0031

Investigational Site Number :3920005, Chuo-ku

185-0014

Investigational Site Number :3920015, Kokubunji-shi

140-8522

Investigational Site Number :3920016, Shinagawa-ku

170-0003

Investigational Site Number :3920004, Toshima-ku

06700

Investigational Site Number :4840006, Mexico City

60-214

Investigational Site Number :6160016, Poznan

61-578

Investigational Site Number :6160006, Poznan

86-300

Investigational Site Number :6160009, Grudziądz

31-559

Investigational Site Number :6160007, Krakow

05-825

Investigational Site Number :6160015, Grodzisk Mazowiecki

01-456

Investigational Site Number :6160012, Warsaw

15-044

Investigational Site Number :6160008, Bialystok

82-300

Investigational Site Number :6160014, Elblag

40-648

Investigational Site Number :6160011, Katowice

011461

Investigational Site Number :6420001, Bucharest

030303

Investigational Site Number :6420009, Bucharest

050159

Investigational Site Number :6420008, Bucharest

066 01

Investigational Site Number :7030006, Humenné

058 01

Investigational Site Number :7030001, Poprad

05201

Investigational Site Number :7030002, Spišská Nová Ves

03080

Investigational Site Number :4100001, Seoul

03312

Investigational Site Number :4100009, Seoul

05505

Investigational Site Number :4100007, Seoul

08035

Investigational Site Number :7240002, Barcelona

08830

Investigational Site Number :7240007, Sant Boi de Llobregat

06800

Investigational Site Number :7240005, Mérida / Badajoz

07120

Investigational Site Number :7240010, Palma de Mallorca

221 85

Investigational Site Number :7520001, Lund

114 46

Investigational Site Number :7520002, Stockholm

06100

Investigational Site Number :7920004, Ankara

02125

Investigational Site Number :8040004, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY