Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,127

Participants

Timeline

Start Date

December 16, 2020

Primary Completion Date

April 11, 2025

Study Completion Date

August 27, 2025

Conditions
Chronic Obstructive Pulmonary Disease
Interventions
DRUG

Itepekimab SAR440340

Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

DRUG

Placebo

Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

Trial Locations (248)

159

Investigational Site Number : 2680001, Tbilisi

220

Investigational Site Number : 1580002, New Taipei City

807

Investigational Site Number : 1580005, Kaohsiung City

1233

Investigational Site Number : 1000001, Sofia

Investigational Site Number : 1000004, Sofia

1407

Investigational Site Number : 1000002, Sofia

1756

Investigational Site Number : 1000009, Sofia

2100

Investigational Site Number : 3480001, Gödöllö

3700

Investigational Site Number : 1000008, Vidin

4031

Investigational Site Number : 3480004, Debrecen

5000

Investigational Site Number : 1000007, Veliko Tyrnovo

5500

Investigational Site Number : 0320004, Mendoza

6000

Investigational Site Number : 1000006, Stara Zagora

6001

Investigational Site Number : 1000003, Stara Zagora

6400

Investigational Site Number : 1000005, Dimitrovgrad

7635

Investigational Site Number : 3480003, Pécs

9200

Investigational Site Number : 3480002, Mosonmagyaróvár

10002

Investigational Site Number : 1580004, Taipei

10549

Northwell Health Site Number : 8400019, Mount Kisco

11031

Investigational Site Number : 1580003, Taipei

11527

Investigational Site Number : 3000006, Athens

12304

WellNow Urgent Care and Clinical Research Site Number : 8400378, Schenectady

15300

Investigational Site Number : 2030005, Praha 5 - Radotin

15801

Clinical Research of Central PA Site Number : 8400023, DuBois

17562

Investigational Site Number : 3000008, Palaio Faliro, Athens

18200

Investigational Site Number : 2030003, Prague

20089

Investigational Site Number : 3800003, Rozzano

20116

Investigational Site Number : 4840013, Aguascalientes

27103

Southeastern Research Center Site Number : 8400011, Winston-Salem

27834

East Carolina University Brody School Of Medicine Site Number : 8400022, Greenville

28054

Gastonia Pharmaceutical Research Site Number : 8400010, Gastonia

28150

Carolina Research Center Site Number : 8400005, Shelby

28401

Accellacare Site Number : 8400001, Wilmington

29201

Bogan Sleep Consultants Site Number : 8400181, Columbia

29732

Clinical Research of Rock Hill Site Number : 8400008, Rock Hill

30046

Gwinnett Biomedical Research Site Number : 8400007, Lawrenceville

30103

Appalachian Clinical Research Site Number : 8400024, Adairsville

30344

Covenant Pulmonary Critical Care Site Number : 8400183, Atlanta

30350

Alpha Clinical Research Georgia Site Number : 8400190, Dunwoody

31015

David Kavtaradze MD, Inc. Site Number : 8400029, Cordele

32159

Premier Medical Associates Site Number : 8400388, The Villages

32503

Avanza Medical Research Center Site Number : 8400376, Pensacola

33012

Indago Research and Health Center Site Number : 8400187, Hialeah

33014

Deluxe Health Center Site Number : 8400188, Miami Lakes

33025

Tellabio International Research Services Site Number : 8400411, Pembroke Pines

33125

University of Miami/Miami VA Medical Center Site Number : 8400026, Miami

33155

DL Research Solutions Inc Site Number : 8400033, Miami

My Community Research Center Site Number : 8400347, Miami

33156

Advanced Clinical Research Site Number : 8400409, Kendall

33157

Beautiful Minds Clinical Research Center Site Number : 8400037, Cutler Bay

33165

Reliant Medical Research Site Number : 8400397, Miami

33173

Research Institute of South Florida,Inc Site Number : 8400006, Miami

33175

PROLIVE MEDICAL RESEARCH Site Number : 8400420, Miami

33176

Reed Medical Research Site Number : 8400032, Miami

33184

High Quality Research Site Number : 8400406, Miami

33324

Broward Pulmonary and Sleep Specialists Site Number : 8400031, Plantation

33470

Advanced Pulmonary Research Institute Site Number : 8400455, Loxahatchee Groves

33607

AdtreMed Site Number : 8400442, Tampa

33707

Coastal Medical Research Institute Site Number : 8400044, St. Petersburg

33710

Pasadena Center for Medical Research Site Number : 8400043, St. Petersburg

33765

Clin Research W Florida Site Number : 8400004, Clearwater

34294

University of Alabama at Birmingham Site Number : 8400012, Birmingham

34362

Investigational Site Number : 3760008, Haifa

35501

Jasper Summit Research Site Number : 8400178, Jasper

37134

Investigational Site Number : 3800007, Verona

37701

Investigational Site Number : 2030001, Jindrichuv Hradec III

40447

Investigational Site Number : 1580006, Taichung

41110

Investigational Site Number : 3000007, Larissa

44100

Investigational Site Number : 4840001, Guadalajara

44124

Investigational Site Number : 3800001, Ferrara

44130

Investigational Site Number : 4840011, Guadalajara

44210

Investigational Site Number : 4840010, Guadalajara

44281

Investigational Site Number : 3760006, Kfar Saba

45215

WellNow Urgent Care and Research Site Number : 8400039, Springdale

45236

Bernstein Clinical Research Center Site Number : 8400014, Cincinnati

46324

ASHA Clinical Research Site Number : 8400408, Hammond

48088

Advanced Pulmonary Research Institute of Michigan Site Number : 8400403, Warren

48126

Revival Research Institute, LLC Site Number : 8400191, Dearborn

49100

Investigational Site Number : 3760001, Petah Tikva

57010

Investigational Site Number : 3000002, Thessaloniki

60805

GenHarp Clinical Solutions Site Number : 8400028, Evergreen Park

61039

Investigational Site Number : 8040008, Kharkiv

61166

Investigational Site Number : 8040006, Kharkiv

62250

Investigational Site Number : 4840007, Cuernavaca

63301

Midwest Chest Consultants, P.C. Site Number : 8400002, Saint Charles

63401

Hannibal Clinic Site Number : 8400383, Hannibal

64239

Investigational Site Number : 3760007, Tel Aviv

68000

Investigational Site Number : 4840014, Oaxaca City

68020

Investigational Site Number : 4840016, Oaxaca City

70433

Benchmark Research Site Number : 8400193, Covington

70800

Investigational Site Number : 2030004, Ostrava

71122

Investigational Site Number : 3800004, Foggia

71500

Investigational Site Number : 3000004, Heraklion

72218

Investigational Site Number : 4800001, Quatre Bornes

75007

Clinrx Research Site Number : 8400021, Carrollton

75020

Premier Pulmonary Critical Care and Sleep Medicine Site Number : 8400440, Denison

75024

Clincove: Plano Primary Care Clinic Site Number : 8400424, Plano

75069

Metroplex Pulmonary and Sleep Center Site Number : 8400015, McKinney

75092

Advance Lung and Sleep Center Site Number : 8400040, Sherman

Sherman Clinical Research Site Number : 8400009, Sherman

75093

EPW Curesearch Dallas (Advanced Family Medical Care) Site Number : 8400414, Plano

75110

Corsicana Medical Research, LLC Site Number : 8400018, Corsicana

75149

PRX Research Site Number : 8400380, Mesquite

76018

Investigational Site Number : 8040003, Ivano-Frankivsk

Investigational Site Number : 8040007, Ivano-Frankivsk

76100

Investigational Site Number : 3760004, Rehovot

76180

The Lung and Sleep Research Institute of North Texas Site Number : 8400417, North Richland Hills

76800

Investigational Site Number : 4840003, San Juan del Río

77030

The Methodist Hospital Research Institute Site Number : 8400194, Houston

77087

Santa Clara Family Clinic Site Number : 8400398, Houston

77375

DM Clinical Research Site Number : 8400179, Tomball

77598

Clearlake Specialties Site Number : 8400025, Webster

77701

REX Clinical Trials Site Number : 8400371, Beaumont

78641

Austin Pulmonary Consultants Site Number : 8400035, Cedar Park

79911

Texas Tech University Health Sciences Center Site Number : 8400189, El Paso

80026

Innovative Clinical Research Site Number : 8400017, Lafayette

80301

~Alpine Clinical Research Center Site Number : 8400180, Boulder

85027

Pulmonary Associates Site Number : 8400392, Phoenix

85286

Chandler Clinical Trials (Elite Clinical Network) Site Number : 8400034, Chandler

85712

Tucson Clinical Research Institute Site Number : 8400431, Tucson

89052

Hendeson Clinical Trials Site Number : 8400365, Henderson

90017

Downtown LA Research Center Inc. Site Number : 8400027, Los Angeles

90048

MACRO Trials Site Number : 8400030, Los Angeles

90255

California Research Institute Site Number : 8400400, Huntington Park

90623

Imax Clinical Trials LLC 1 Site Number : 8400419, La Palma

91031

Investigational Site Number : 3760003, Jerusalem

91120

Investigational Site Number : 3760002, Jerusalem

91325

Antelope Valley Clinical Trials Site Number : 8400003, Northridge

92037

Modena Allergy + Asthma Site Number : 8400036, La Jolla

93401

Investigational Site Number : 7030003, Levice

95123

Investigational Site Number : 3800005, Catania

100020

Investigational Site Number : 1560004, Beijing

100038

Investigational Site Number : 1560030, Beijing

110004

Investigational Site Number : 1560005, Shenyang

115093

Investigational Site Number : 6430001, Moscow

115280

Investigational Site Number : 6430003, Moscow

117546

Investigational Site Number : 6430002, Moscow

130021

Investigational Site Number : 1560002, Changchun

194354

Investigational Site Number : 6430005, Saint Petersburg

Investigational Site Number : 6430006, Saint Petersburg

200025

Investigational Site Number : 1560043, Shanghai

200240

Investigational Site Number : 1560034, Shanghai

200433

Investigational Site Number : 1560009, Shanghai

210009

Investigational Site Number : 1560035, Nanjing

221002

Investigational Site Number : 1560007, Xuzhou

225001

Investigational Site Number : 1560026, Yangzhou

250013

Investigational Site Number : 1560044, Jinan

250014

Investigational Site Number : 1560027, Jinan

300052

Investigational Site Number : 1560024, Tianjin

300134

Investigational Site Number : 6420003, Timișoara

302039

Investigational Site Number : 3560004, Jaipur

310014

Investigational Site Number : 1560022, Hangzhou

325000

Investigational Site Number : 1560019, Wenzhou

330006

Investigational Site Number : 1560031, Nanchang

330162

Investigational Site Number : 6420010, Deva

337055

Investigational Site Number : 1560015, Pingxiang

400038

Investigational Site Number : 1560032, Chongqing

400078

Investigational Site Number : 3560007, Mumbai

400275

Investigational Site Number : 6420002, Cluj-Napoca

410011

Investigational Site Number : 1560012, Changsha

410013

Investigational Site Number : 1560013, Changsha

410023

Investigational Site Number : 1560047, Changsha

410155

Investigational Site Number : 6420009, Oradea

411100

Investigational Site Number : 1560046, Xiangtan

430014

Investigational Site Number : 1560029, Wuhan

441203

Investigational Site Number : 3560003, Nagpur

450008

Investigational Site Number : 1560042, Zhengzhou

500450

Investigational Site Number : 6420006, Brasov

505100

Investigational Site Number : 6420007, Codlea

510150

Investigational Site Number : 1560006, Guangzhou

510163

Investigational Site Number : 1560025, Guangzhou

518020

Investigational Site Number : 1560020, Shenzhen

524001

Investigational Site Number : 1560041, Zhanjiang

528403

Investigational Site Number : 1560048, Zhongshan

530021

Investigational Site Number : 1560023, Nanning

570216

Investigational Site Number : 1560036, Haikou

610041

Investigational Site Number : 1560001, Chengdu

611130

Investigational Site Number : 1560040, Chengdu

641028

Investigational Site Number : 3560002, Coimbatore

673008

Investigational Site Number : 3560001, Kozhikode

700732

Investigational Site Number : 6420001, Iași

769764

Investigational Site Number : 6420005, Bragadiru

2260877

Investigational Site Number : 1520005, Quillota

3341643

Investigational Site Number : 1520007, Curicó

4781173

Investigational Site Number : 1520008, Temuco

5266202

Investigational Site Number : 3760009, Ramat Gan

7500010

Investigational Site Number : 1520009, Santiago

7500571

Investigational Site Number : 1520003, Santiago

7500692

Investigational Site Number : 1520001, Santiago

7500698

Investigational Site Number : 1520006, Santiago

7750495

Investigational Site Number : 1520004, Santiago

85704-7876

Noble Clinical Research Site Number : 8400182, Tucson

32825-4454

Florida Institute for Clinical Research Site Number : 8400013, Orlando

04401

Paul Shapero, PC Site Number : 8400016, Bangor

02110

Care Access Site Number : 8400276, Boston

Care Access Site Number : 8400277, Boston

Care Access Site Number : 8400278, Boston

Care Access Site Number : 8400280, Boston

Care Access Site Number : 8400281, Boston

02723

Exordia Medical Research, Inc. Site Number : 8400041, Fall River

77043-2742

Biopharma Informatic - Cardiff Avenue - PPDS Site Number : 8400038, Houston

C1425BEN

Investigational Site Number : 0320001, CABA

C1425FVH

Investigational Site Number : 0320002, CABA

B1900BNN

Investigational Site Number : 0320005, La Plata

S2000DEJ

Investigational Site Number : 0320003, Rosario

Unknown

Investigational Site Number : 1520002, Talca

Investigational Site Number : 1560014, Beijing

Investigational Site Number : 1560039, Hangzhou

Investigational Site Number : 1560017, Hefei

Investigational Site Number : 1560045, Shanghai

Investigational Site Number : 1560016, Xi'an

Investigational Site Number : 1580008, Yunlin

014010

Investigational Site Number : 1560003, Baotou

010017

Investigational Site Number : 1560008, Hohhot

010050

Investigational Site Number : 1560010, Hohhot

050000

Investigational Site Number : 1560028, Shijiazhuang

580 01

Investigational Site Number : 2030006, Havlíčkův Brod

140 46

Investigational Site Number : 2030002, Prague

0112

Investigational Site Number : 2680002, Tbilisi

Investigational Site Number : 2680003, Tbilisi

106 76

Investigational Site Number : 3000005, Athens

455 00

Investigational Site Number : 3000001, Ioannina

500 084

Investigational Site Number : 3560005, Hyderabad

06700

Investigational Site Number : 4840002, Mexico City

03100

Investigational Site Number : 4840004, Benito Juárez

53-673

Investigational Site Number : 6160004, Wroclaw

02-777

Investigational Site Number : 6160003, Warsaw

15-044

Investigational Site Number : 6160001, Bialystok

27-400

Investigational Site Number : 6160002, Ostrowiec Świętokrzyski

010192

Investigational Site Number : 6420012, Bucaresti

08501

Investigational Site Number : 7030009, Bardejov

066 01

Investigational Site Number : 7030007, Humenné

03659

Investigational Site Number : 7030011, Martin

058 01

Investigational Site Number : 7030002, Poprad

08001

Investigational Site Number : 7030010, Prešov

05201

Investigational Site Number : 7030001, Spišská Nová Ves

01023

Investigational Site Number : 8040004, Kyiv

01033

Investigational Site Number : 8040001, Kyiv

02091

Investigational Site Number : 8040005, Kyiv

04050

Investigational Site Number : 8040011, Kyiv

PO6 3LY

Investigational Site Number : 8260004, Portsmouth

OL69RW

Investigational Site Number : 8260015, Ashton-under-Lyne

WN6 9EP

Investigational Site Number : 8260010, Wigan

M6 8HD

Investigational Site Number : 8260016, Salford

BD9 6RJ

Investigational Site Number : 8260003, Bradford

TW5 9ER

Investigational Site Number : 8260014, Heston

EC1M 6BQ

Investigational Site Number : 8260001, London

TR16 4ET

Investigational Site Number : 8260013, Redruth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY