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

PHASE3CompletedINTERVENTIONAL
Enrollment

935

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

February 28, 2024

Study Completion Date

May 27, 2024

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 (334)

1000

Investigational Site Number : 1005018, Sofia

1050

Investigational Site Number : 7100012, Middelburg

1142

Investigational Site Number : 1005003, Sofia

1233

Investigational Site Number : 1005001, Sofia

Investigational Site Number : 1005006, Sofia

1407

Investigational Site Number : 1005002, Sofia

1500

Investigational Site Number : 7100015, Benoni

1618

Investigational Site Number : 1005026, Sofia

1769

Investigational Site Number : 6200009, Lisbon

1935

Investigational Site Number : 7100011, Gauteng

2100

Investigational Site Number : 3480004, Gödöllö

2440

Investigational Site Number : 3480001, Százhalombatta

2600

Investigational Site Number : 1005021, Dupnitsa

2650

Investigational Site Number : 0560002, Edegem

2800

Investigational Site Number : 0560004, Mechelen

3000

Investigational Site Number : 0560001, Leuven

Investigational Site Number : 1005020, Vratsa

3168

Investigational Site Number : 0360005, Clayton

3403

Investigational Site Number : 1005011, Montana

3700

Investigational Site Number : 1005019, Vidin

3780

Investigational Site Number : 3480003, Edelény

4000

Investigational Site Number : 0560003, Liège

4001

Investigational Site Number : 7100001, Durban

Investigational Site Number : 7100013, Durban

4002

Investigational Site Number : 1005008, Plovdiv

4071

Investigational Site Number : 7100003, Durban

4080

Investigational Site Number : 3480002, Hajdunánás

4091

Investigational Site Number : 7100014, Chatsworth

4302

Investigational Site Number : 7100010, Durban

5000

Investigational Site Number : 1005023, Veliko Tyrnovo

Investigational Site Number : 1005027, Veliko Tyrnovo

5067

Investigational Site Number : 0360008, Kent Town

6000

Investigational Site Number : 1005024, Stara Zagora

6001

Investigational Site Number : 1005004, Stara Zagora

6163

Investigational Site Number : 0360001, Spearwood

6305

Investigational Site Number : 1005012, Haskovo

7002

Investigational Site Number : 1005013, Rousse

7130

Investigational Site Number : 7100008, Somerset West

7240

Investigational Site Number : 0320013, Lobos

7500

Investigational Site Number : 7100004, Cape Town

Investigational Site Number : 7100006, Parow

7764

Investigational Site Number : 7100002, Gatesville

8000

Investigational Site Number : 1005025, Burgas

9200

Investigational Site Number : 3480006, Mosonmagyaróvár

9700

Investigational Site Number : 3480005, Szombathely

10002

Investigational Site Number : 7240012, Cáceres

10675

Investigational Site Number : 3000006, Athens

10961

Investigational Site Number : 2760024, Berlin

11000

Investigational Site Number : 6880005, Belgrade

Investigational Site Number : 6880006, Belgrade

Investigational Site Number : 6880007, Belgrade

11040

Northwell Health Site Number : 8400054, New Hyde Park

11527

Investigational Site Number : 3000001, Athens

12159

Investigational Site Number : 2760025, Berlin

14000

Investigational Site Number : 6880002, Valjevo

14050

Investigational Site Number : 4840007, Mexico City

14051

WellNow Urgent Care Site Number : 8400132, East Amherst

14787

Great Lakes Medical Research Site Number : 8400044, Westfield

15004

Investigational Site Number : 6040004, Lima

15683

Frontier Clinical Research, LLC Site Number : 8400049, Scottdale

15801

Clinical Research of Central PA Site Number : 8400009, DuBois

17562

Investigational Site Number : 3000007, Palaio Faliro, Athens

20000

Investigational Site Number : 6040005, Piura

20354

Investigational Site Number : 2760002, Hamburg

21079

Investigational Site Number : 2500002, Dijon

21204

Investigational Site Number : 6880001, Kamenitz

23236

Clinical Research Partners Site Number : 8400040, Richmond

23552

Investigational Site Number : 2760010, Lübeck

24210

Pulmonary Research of Abingdon, LLC Site Number : 8400030, Abingdon

27103

Southeastern Research Center Site Number : 8400068, Winston-Salem

28046

Investigational Site Number : 7240003, Madrid

28054

Clinical Research of Gastonia Site Number : 8400010, Gastonia

28112

Monroe Biomedical Research Site Number : 8400087, Monroe

28117

Lake Norman Pulmonary and Sleep Medicine - Mooresville Site Number : 8400006, Mooresville

Lapis Clinical Research At BlueSkies Family Medicine Site Number : 8400117, Mooresville

28277

Onsite Clinical Solutions LLC Site Number : 8400042, Charlotte

28562

Coastal Carolina Health Care, P.A. Site Number : 8400025, New Bern

29010

Investigational Site Number : 7240010, Málaga

29325

Carolina Medical Research, LLC Site Number : 8400026, Clinton

29577

LLM Research Site Number : 8400125, Myrtle Beach

29720

MD First Research Site Number : 8400105, Lancaster

30024

Herman Clinical Research LLC Site Number : 8400078, Suwanee

30046

Gwinnett Biomedical Research Site Number : 8400052, Lawrenceville

30094

Medical Centre of Conyers Site Number : 8400064, Conyers

30103

Appalachian Clinical Research Site Number : 8400048, Adairsville

30173

Investigational Site Number : 2760003, Hanover

30345

Northlake Medical Group Site Number : 8400099, Atlanta

30513

River Birch Research, LLC Site Number : 8400045, Blue Ridge

31000

Investigational Site Number : 4840010, Chihuahua City

31015

David Kavtaradze MD, Inc. Site Number : 8400135, Cordele

31224

Investigational Site Number : 2760020, Peine

31326

Southeast Lung Associates Site Number : 8400003, Rincon

32713

Omega Research Consultants, LLC Site Number : 8400021, DeBary

32789

Florida Pulmonary Research Center Site Number : 8400001, Winter Park

32825

Central Florida Pulmonary Group, PA Site Number : 8400101, Orlando

33011

Investigational Site Number : 7240007, Oviedo

33012

Direct Helpers Medical Center Inc Site Number : 8400079, Hialeah

33155

DL Research Solutions Inc Site Number : 8400089, Miami

33157

Beautiful Minds Clinical Research Center Site Number : 8400081, Cutler Bay

Innovation Medical Research Center Site Number : 8400114, Palmetto Bay

33165

Phoenix Medical Research, LLC Site Number : 8400012, Miami

33174

Columbus Clinical Services Site Number : 8400062, Miami

33176

Reed Medical Research Site Number : 8400123, Miami

33178

Sciences Connections, LLC Site Number : 8400133, Doral

33184

De La Cruz Research Center, LLC Site Number : 8400075, Miami

33308

InvesClinic, LLC Site Number : 8400039, Fort Lauderdale

33435

Helix Biomedics, LLC Site Number : 8400035, Boynton Beach

33437

Pioneer Clinical Research Site Number : 8400043, Boynton Beach

33467

Finlay Medical Research Site Number : 8400071, Greenacres City

33563

Family Medical Specialists of Florida, PA Site Number : 8400077, Plant City

33600

Investigational Site Number : 2500006, Pessac

33704

Coastal Pulmonary And Critical Care Site Number : 8400013, St. Petersburg

33765

St. Francis Sleep, Allergy and Lung Institute Site Number : 8400020, Clearwater

33991

Renaissance Research and Medical Group, Inc Site Number : 8400092, Cape Coral

34000

Investigational Site Number : 4840006, Durango

Investigational Site Number : 6880003, Kragujevac

34295

Investigational Site Number : 2500003, Montpellier

35043

Investigational Site Number : 2760008, Marburg

35055

Cullman Research Center, LLC Site Number : 8400095, Cullman

35501

Pulmonary & Sleep Associates of Jasper PC Site Number : 8400090, Jasper

35768

Scottsboro Quick Care Clinic Site Number : 8400116, Scottsboro

37055

Pulmonary & Sleep Specialists Site Number : 8400136, Dickson

37067

Clinical Trials Center of Middle Tennessee Site Number : 8400066, Franklin

37601

MultiSpecialty Clinical Research Site Number : 8400110, Johnson City

37701

Investigational Site Number : 2030001, Jindrichuv Hradec III

38601

Investigational Site Number : 2030002, Strakonice

43235

Optimed Research, LTD Site Number : 8400082, Columbus

43617

Toledo Institute of Clinical Research Site Number : 8400024, Toledo

44100

Investigational Site Number : 4840002, Guadalajara

44320

Investigational Site Number : 4400001, Kaunas

44670

Investigational Site Number : 4840013, Guadalajara

44800

Investigational Site Number : 2500001, Saint-Herblain

45070

Investigational Site Number : 4840011, Zapopan

46000

Investigational Site Number : 8040010, Ternopil

46017

Investigational Site Number : 7240008, Valencia

48076

Revive Research Institute Site Number : 8400120, Lathrup Village

48202

Henry Ford Health System Site Number : 8400053, Detroit

48307

Romedica, LLC Site Number : 8400034, Rochester

48638

Covenant Healthcare Site Number : 8400057, Saginaw

49449

Investigational Site Number : 4400003, Kaunas

50009

Investigational Site Number : 7240011, Zaragoza

50161

Investigational Site Number : 4400008, Kaunas

53228

Allergy, Asthma & Sinus Center, S.C. Site Number : 8400088, Greenfield

55128

Investigational Site Number : 2760012, Mainz

56068

Investigational Site Number : 2760007, Koblenz

57010

Investigational Site Number : 3000004, Thessaloniki

57702

Health Concepts Site Number : 8400027, Rapid City

58001

Investigational Site Number : 8040011, Chernivtsi

58633

Investigational Site Number : 2030004, Jihlava

59808

Montana Medical Research Site Number : 8400019, Missoula

60596

Investigational Site Number : 2760009, Frankfurt am Main

61124

Investigational Site Number : 8040001, Kharkiv

64100

Investigational Site Number : 2500009, Bayonne

64283

Investigational Site Number : 2760017, Darmstadt

64710

Investigational Site Number : 4840004, Monterrey

65183

Investigational Site Number : 2760018, Wiesbaden

66465

Investigational Site Number : 4840003, Monterrey

67000

Investigational Site Number : 4840009, Mexico City

67172

Investigational Site Number : 2030003, Miroslav

68114

Quality Clinical Research, Inc. Site Number : 8400073, Omaha

68510

Somnos Clinical Research Site Number : 8400016, Lincoln

69004

Investigational Site Number : 2500005, Lyon

69076

Investigational Site Number : 8040008, Zaporizhzhia

69600

Investigational Site Number : 8040009, Zaporizhzhya

70000

Investigational Site Number : 1005015, Rousse

70526

Avant Research Associates LLC Site Number : 8400118, Crowley

71500

Investigational Site Number : 3000003, Heraklion

72209

Asthma and Allergy Institute Site Number : 8400022, Little Rock

73120

Allergy, Asthma and Clinical Research Center Site Number : 8400127, Oklahoma City

75007

Clinrx Research Site Number : 8400059, Carrollton

75014

Investigational Site Number : 2500007, Paris

75015

Investigational Site Number : 2500008, Paris

75024

Clinrx Research, LLC Site Number : 8400069, Plano

75069

Metroplex Pulmonary and Sleep Center Site Number : 8400131, McKinney

75605

DCOL Center for Clinical Research Site Number : 8400028, Longview

76018

Investigational Site Number : 8040002, Ivano-Frankivsk

Investigational Site Number : 8040003, Ivano-Frankivsk

77054

Prolato Clinical Research Center Site Number : 8400128, Houston

77099

Pioneer Research Solutions, Inc. Site Number : 8400070, Houston

77429

Houston Pulmonary and Sleep Associates Site Number : 8400011, Cypress

77479

Mt. Olympus Medical Research Site Number : 8400115, Sugar Land

77701

REX Clinical Trials Site Number : 8400143, Beaumont

78229

Diagnostics Research Group Site Number : 8400038, San Antonio

79011

Investigational Site Number : 8040006, Lviv

80026

Innovative Clinical Research Site Number : 8400018, Lafayette

83022

Investigational Site Number : 2760016, Rosenheim

85283

Medical Advancement Center of Arizona Site Number : 8400107, Tempe

85381

Phoenix Medical Group Site Number : 8400061, Peoria

91730

Prospective Research Innovations, Inc. Site Number : 8400063, Rancho Cucamonga

91910

Investigational Site Number : 4840005, Veracruz

92119

ACRC Studies Site Number : 8400094, San Diego

92120

Institute of HealthCare Assessment, Inc. Site Number : 8400015, San Diego

92231

Investigational Site Number : 4400007, Klaipėda

92663

NewportNativeMD, Inc Site Number : 8400032, Newport Beach

92683

Allianz Research Institute Site Number : 8400007, Westminster

93301

Kern Research, Inc Site Number : 8400031, Bakersfield

93401

Investigational Site Number : 7030003, Levice

97401

Investigational Site Number : 7030007, Banská Bystrica

110117

Investigational Site Number : 6425006, Piteşti

115093

Investigational Site Number : 6430001, Moscow

115280

Investigational Site Number : 6430003, Moscow

125284

Investigational Site Number : 6430002, Moscow

170004

Investigational Site Number : 1700005, Manizales

194354

Investigational Site Number : 6430004, Saint Petersburg

198328

Investigational Site Number : 6430013, Saint Petersburg

300134

Investigational Site Number : 6425001, Timișoara

355020

Investigational Site Number : 6430012, Stavropol

394066

Investigational Site Number : 6430005, Voronezh

400275

Investigational Site Number : 6425003, Cluj-Napoca

432017

Investigational Site Number : 6430008, Ulyanovsk

600252

Investigational Site Number : 6425004, Bacau

603126

Investigational Site Number : 6430009, Nizhny Novgorod

634034

Investigational Site Number : 6430006, Tomsk

700732

Investigational Site Number : 6425002, Iași

900002

Investigational Site Number : 6425005, Constanța

928260

Investigational Site Number : 6430014, Saint Petersburg

2260877

Investigational Site Number : 1520004, Quillota

3341643

Investigational Site Number : 1520006, Curicó

5110683

Investigational Site Number : 1520009, Valdivia

7500571

Investigational Site Number : 1520007, Santiago

7500692

Investigational Site Number : 1520003, Santiago

8910131

Investigational Site Number : 1520002, Santiago

11001000

Investigational Site Number : 1700002, Bogotá

32825-4454

Florida Institute for Clinical Research Site Number : 8400129, Orlando

02723

Genesis Clinical Research & Consulting Site Number : 8400050, Fall River

02747

Infinity Medical Research Site Number : 8400004, South Dartmouth

48075-5400

Great Lakes Research Institute Site Number : 8400096, Southfield

07304

Jersey City Breathing Center Site Number : 8400137, Jersey City

12553-7754

Mid Hudson Medical Research PLLC Site Number : 8400037, New Windsor

77043-2742

Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400055, Houston

76550-1820

Radiance Clinical Research Site Number : 8400029, Lampasas

CP 1884

Investigational Site Number : 0320007, Berazategui

C1122AAK

Investigational Site Number : 0320006, CABA

C1414AIF

Investigational Site Number : 0320004, CABA

C1425BEN

Investigational Site Number : 0320001, CABA

C1425FVH

Investigational Site Number : 0320003, CABA

B1900BNN

Investigational Site Number : 0320010, La Plata

B1878FNR

Investigational Site Number : 0320005, Quilmes

X5003DCE

Investigational Site Number : 0320011, Córdoba

S2000DEJ

Investigational Site Number : 0320008, Rosario

S2002OJP

Investigational Site Number : 0320009, Rosario

C1121ABE

Investigational Site Number : 0320002, Buenos Aires

B1824KAJ

Investigational Site Number : 0320012, Launs Este

29055 450

CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES Site Number : 0760020, Vitória

40150-150

SER da Bahia Site Number : 0760019, Salvador

99010-120

Instituto Mederi de Pesquisa e Saude Site Number : 0760008, Passo Fundo

90020-090

Irmandade da Santa Casa de Misericordia de Porto Alegre Site Number : 0760017, Porto Alegre

90160-090

Hospital Sao Lucas Site Number : 0760001, Porto Alegre

89030-100

HOSPITAL DIA DO PULMAO Site Number : 0760006, Blumenau

88040-970

UFSC - Hospital Universitário Site Number : 0760018, Florianópolis

13059-900

PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 0760015, Campinas

09060-870

FUNDACAO DO ABC - FACULDADE DE MEDICINA DO ABC (FMABC) Site Number : 0760007, Santo André

01228-000

CPQuali Pesquisa Clinica Site Number : 0760003, São Paulo

01229-010

Instituto de Pesquisa Grupo NotreDame Intermedica Site Number : 0760012, São Paulo

04014-002

Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo Site Number : 0760021, São Paulo

05403-900

InCor - Instituto do Coraçao do Hospital das Clinicas da FMUSP Site Number : 0760002, São Paulo

18040-425

Clinica de Alergia Martti Antila Site Number : 0760009, Sorocaba

T3L 3E6

Investigational Site Number : 1240015, Calgary

V2C 5T1

Investigational Site Number : 1240018, Kamloops

V1Y 4N7

Investigational Site Number : 1240017, Kelowna

E1G 5C4

Investigational Site Number : 1240014, Moncton

L1S 2J5

Investigational Site Number : 1240010, Ajax

N7T 4X3

Investigational Site Number : 1240009, Sarnia

N8X 1T3

Investigational Site Number : 1240007, Windsor

H3T 1E2

Investigational Site Number : 1240004, Montreal

G1V 4W2

Investigational Site Number : 1240012, Québec

G1G 3Y8

Investigational Site Number : 1240001, Québec

G2J 0C4

Investigational Site Number : 1240005, Québec

Unknown

Investigational Site Number : 1520001, Talca

Investigational Site Number : 1700007, Bucaramanga

Investigational Site Number : 6430010, Ryazan

580 01

Investigational Site Number : 2030009, Havlíčkův Brod

278 01

Investigational Site Number : 2030007, Kralupy nad Vltavou

288 01

Investigational Site Number : 2030010, Nymburk

04299

Investigational Site Number : 2760023, Leipzig

04347

Investigational Site Number : 2760011, Leipzig

455 00

Investigational Site Number : 3000002, Ioannina

LV-4501

Investigational Site Number : 4280008, Balvi

LV - 4601

Investigational Site Number : 4280007, Rēzekne

LV -1010

Investigational Site Number : 4280001, Riga

Investigational Site Number : 4280005, Riga

LV -1021

Investigational Site Number : 4280006, Riga

LV-1002

Investigational Site Number : 4280002, Riga

LV-1038

Investigational Site Number : 4280003, Riga

04130

Investigational Site Number : 4400005, Vilnius

03100

Investigational Site Number : 4840008, Benito Juárez

6815 AD

Investigational Site Number : 5280005, Arnhem

4818 CK

Investigational Site Number : 5280001, Breda

3318 AT

Investigational Site Number : 5280010, Dordrecht

3844 DG

Investigational Site Number : 5280009, Harderwijk

8934 AD

Investigational Site Number : 5280002, Leeuwarden

6532 SZ

Investigational Site Number : 5280006, Nijmegen

6043 CV

Investigational Site Number : 5280011, Roermond

7207 AE

Investigational Site Number : 5280008, Zutphen

8025 AB

Investigational Site Number : 5280004, Zwolle

021

Investigational Site Number : 6040006, Lima

LIMA 31

Investigational Site Number : 6040001, Lima

Lima 01

Investigational Site Number : 6040002, Lima Lima

86-300

Investigational Site Number : 6160009, Grudziądz

31-559

Investigational Site Number : 6160007, Krakow

05-825

Investigational Site Number : 6160015, Grodzisk Mazowiecki

35-205

Investigational Site Number : 6160010, Rzeszów

15-044

Investigational Site Number : 6160008, Bialystok

40-611

Investigational Site Number : 6160018, Katowice

40-648

Investigational Site Number : 6160011, Katowice

82-300

Investigational Site Number : 6160014, Elblag

30-033

Investigational Site Number : 6160019, Krakow

67-100

Investigational Site Number : 6160020, Nowa Sól

27-400

Investigational Site Number : 6160022, Ostrowiec Świętokrzyski

2801-951

Investigational Site Number : 6200007, Almada

3810-501

Investigational Site Number : 6200006, Aveiro

4810-061

Investigational Site Number : 6200002, Guimarães

4464-513

Investigational Site Number : 6200012, Matosinhos Municipality

066 01

Investigational Site Number : 7030006, Humenné

040 01

Investigational Site Number : 7030005, Košice

058 01

Investigational Site Number : 7030001, Poprad

05201

Investigational Site Number : 7030002, Spišská Nová Ves

0157

Investigational Site Number : 7100009, Johannesburg

Investigational Site Number : 7100005, Pretoria

08023

Investigational Site Number : 7240002, Barcelona

08916

Investigational Site Number : 7240009, Badalona

01033

Investigational Site Number : 8040007, Kyiv

03049

Investigational Site Number : 8040004, Kyiv

CB2 2QQ

Investigational Site Number : 8260003, Cambridge

FY3 7DQ

Investigational Site Number : 8260002, Blackpool

SA2 8QA

Investigational Site Number : 8260006, Swansea

NE29 8NH

Investigational Site Number : 8260007, North Shields

NE34 0PL

Investigational Site Number : 8260004, South Shields

NG5 1PB

Investigational Site Number : 8260013, Nottingham

HP218AL

Investigational Site Number : 8260012, Aylesbury

BD9 6RJ

Investigational Site Number : 8260001, Bradford

BS10 5NB

Investigational Site Number : 8260005, Bristol

SN15 2SB

Investigational Site Number : 8260011, Chippenham

DE223NE

Investigational Site Number : 8260015, Derby

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT04456673 - Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation | Biotech Hunter | Biotech Hunter