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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,239

Participants

Timeline

Start Date

February 12, 2021

Primary Completion Date

April 21, 2025

Study Completion Date

August 28, 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 (297)

1055

Investigational Site Number : 7100012, Middelburg

1060

Investigational Site Number : 0320006, Buenos Aires

1106

Investigational Site Number : 3480009, Budapest

1142

Investigational Site Number : 1000001, Sofia

1478

Investigational Site Number : 5780001, Lørenskog

1500

Investigational Site Number : 7100013, Benoni

1680

Investigational Site Number : 1000006, Sofia

2000

Investigational Site Number : 0320007, Rosario

2440

Investigational Site Number : 3480001, Százhalombatta

2600

Investigational Site Number : 1000013, Dupnitsa

2650

Investigational Site Number : 2080001, Hvidovre

2660

Investigational Site Number : 3480002, Balassagyarmat

2700

Investigational Site Number : 1000008, Blagoevgrad

3403

Investigational Site Number : 1000005, Montana

3780

Investigational Site Number : 3480005, Edelény

4001

Investigational Site Number : 7100005, Durban

Investigational Site Number : 7100017, Durban

4002

Investigational Site Number : 1000002, Plovdiv

4071

Investigational Site Number : 7100006, Durban

4080

Investigational Site Number : 3480004, Hajdunánás

4091

Investigational Site Number : 7100015, Chatsworth

4150

Investigational Site Number : 3480003, Püspökladány

4302

Investigational Site Number : 7100016, Durban

5300

Investigational Site Number : 1000004, Gabrovo

6010

Investigational Site Number : 2680003, Batumi

6305

Investigational Site Number : 1000009, Haskovo

7000

Investigational Site Number : 1000012, Rousse

7002

Investigational Site Number : 1000003, Rousse

7100

Investigational Site Number : 2080003, Vejle

7130

Investigational Site Number : 7100019, Cape Town

7500

Investigational Site Number : 7100003, Parow

7530

Investigational Site Number : 7100002, Cape Town

7764

Investigational Site Number : 7100004, Gatesville

9700

Investigational Site Number : 3480012, Szombathely

10003

Investigational Site Number : 7240010, Cáceres

10787

Investigational Site Number : 2760004, Berlin

10961

Investigational Site Number : 2760009, Berlin

11230

Smart Medical Research Site Number : 8400191, Brooklyn

11355

New York - Presbyterian Queens- Site Number : 8400028, Flushing

12159

Investigational Site Number : 2760010, Berlin

12308

Schenectady Pulmonary and Critical Care Associates- Site Number : 8400029, Schenectady

14050

Investigational Site Number : 4840006, Mexico City

14215

VA Western New York Healthcare System Site Number : 8400050, Buffalo

15212

Allegheny Health Network- Site Number : 8400058, Pittsburgh

18015

St. Luke's University Health Network- Site Number : 8400187, Bethlehem

20230

Investigational Site Number : 4840010, Aguascalientes

20354

Investigational Site Number : 2760002, Hamburg

21224

Johns Hopkins Asthma and Allergy Center- Site Number : 8400055, Baltimore

21431

Investigational Site Number : 4100003, Incheon

23552

Investigational Site Number : 2760003, Lübeck

25198

Investigational Site Number : 7240009, Lleida / Lleida

25801

The Rheumatology and Pulmonary Clinic- Site Number : 8400053, Beckley

26426

Investigational Site Number : 4100002, Wŏnju

28007

Investigational Site Number : 7240003, Madrid

28040

Investigational Site Number : 7240007, Madrid / Madrid

28078

Advanced Respiratory and Sleep Medicine- Site Number : 8400022, Huntersville

28223

Investigational Site Number : 7240008, Pozuelo de Alarcón

28277

American Health Research- Site Number : 8400002, Charlotte

29010

Investigational Site Number : 7240001, Málaga

29204

Medtrial, LLC Site Number : 8400048, Columbia

29301

Investigational Site Number : 2030005, Mladá Boleslav

29340

VitaLink Research- Gaffney- Site Number : 8400003, Gaffney

29406

Lowcountry Lung & Critical Care- Site Number : 8400175, Charleston

30189

North Georgia Clinical Research Site Number : 8400013, Woodstock

30625

Investigational Site Number : 2760014, Hanover

31000

Investigational Site Number : 4840003, Chihuahua City

31605

Medster Research, LLC Site Number : 8400051, Valdosta

32055

Multi-Specialty Research Associates, Inc- Site Number : 8400044, Lake City

32608

North Florida/South Georgia Veterans Health System Site Number : 8400176, Gainesville

32713

Omega Research - Site Number : 8400031, DeBary

32765

Oviedo Medical Research Site Number : 8400026, Oviedo

32803

Central Florida Pulmonary Group, PA- Site Number : 8400192, Orlando

32819

Heuer M.D. Research Site Number : 8400016, Orlando

33012

Direct Helpers Medical Center Inc- Site Number : 8400065, Hialeah

33025

Pines Care Research Center LLC- Site Number : 8400056, Pembroke Pines

33125

Columbus Clinical Services- Site Number : 8400054, Miami

33126

Finlay Medical Research Site Number : 8400007, Miami

MCR Research Site Number : 8400425, Miami

33144

Y and L Advance Health Care, Inc D/B/A Elite Clinical Res- Site Number : 8400009, Miami

33155

My Community Research Center Site Number : 8400060, Miami

33157

Beautiful Minds Clinical Research Center Site Number : 8400352, Cutler Bay

Innovation Medical Research Center- Site Number : 8400067, Palmetto Bay

33165

Phoenix Medical Research- Site Number : 8400019, Miami

33178

Sciences Connections, LLC Site Number : 8400045, Doral

33343

Investigational Site Number : 7920002, Mersin

33435

Helix Biomedics, LLC - Site Number : 8400049, Boynton Beach

33467

Finlay Medical Research- Site Number : 8400011, Greenacres City

33470

Advanced Pulmonary Research Institute Site Number : 8400018, Loxahatchee Groves

33600

Investigational Site Number : 2500003, Pessac

33603

Genesis Clinical Research, LLC Site Number : 8400182, Tampa

33606

Clinical Research of West Florida, Inc- Site Number : 8400008, Tampa

33756

Innovative Research of West Florida, Inc- Site Number : 8400041, Clearwater

34000

Investigational Site Number : 4840007, Durango

34080

Investigational Site Number : 4840012, Durango, Durango

34239

Sarasota Memorial Health Care System Clinical ResearchCenter- Site Number : 8400178, Sarasota

34303

Investigational Site Number : 7920001, Istanbul

34470

Renstar Medical Research- Site Number : 8400015, Ocala

35040

Investigational Site Number : 7920003, Izmir

37067

Clinical Trials Center of Middle Tennessee Site Number : 8400025, Franklin

37701

Investigational Site Number : 2030001, Jindrichuv Hradec III

39008

Investigational Site Number : 7240013, Santander

40502

Lexington VA Health Care System- Site Number : 8400036, Lexington

40747

Investigational Site Number : 2030007, Varnsdorf

43215

Remington-Davis Inc- Site Number : 8400004, Columbus

43617

Toledo Institute of Clinical Research- Site Number : 8400014, Toledo

45267

University of Cincinnati- Site Number : 8400042, Cincinnati

48076

Revive Research Institute Site Number : 8400186, Lathrup Village

48202

Henry Ford Hospital Site Number : 8400052, Detroit

49100

Investigational Site Number : 3760001, Petah Tikva

49449

Investigational Site Number : 4400002, Kaunas

50009

Investigational Site Number : 7240012, Zaragoza

50161

Investigational Site Number : 4400001, Kaunas

50266

The Iowa Clinic Site Number : 8400034, West Des Moines

50406

Investigational Site Number : 2330001, Tartu

51090

Investigational Site Number : 2500004, Reims

54311

Aurora BayCare Medical Center Site Number : 8400046, Green Bay

55128

Investigational Site Number : 2760001, Mainz

56068

Investigational Site Number : 2760006, Bendorf

60064

Captain James A. Lovell Federal Health Care Center Site Number : 8400032, North Chicago

60596

Investigational Site Number : 2760005, Frankfurt am Main

61605

Illinois Lung Institute- Site Number : 8400024, Peoria

62208

Care Access Fairview Heights Site Number : 8400033, Fairview Heights

63110

Washington University School of Medicine- Site Number : 8400035, St Louis

63263

Investigational Site Number : 2760012, Neu-Isenburg

64460

Investigational Site Number : 4840001, Monterrey, Nuevo León

64710

Investigational Site Number : 4840008, Monterrey

64718

Investigational Site Number : 4840009, Monterrey

66465

Investigational Site Number : 4840002, Monterrey

66606

Cotton O'Neil Garfield- Site Number : 8400063, Topeka

69004

Investigational Site Number : 2500001, Lyon

70800

Investigational Site Number : 2030004, Ostrava

71105

Pulmonary & Critical Care Site Number : 8400047, Shreveport

71450

Investigational Site Number : 7920006, Kırıkkale

73034

OK Clinical Research LLC- Site Number : 8400001, Edmond

75024

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

76100

Investigational Site Number : 3760004, Rehovot

77091

United Memorial Medical Center (UMMC)- Site Number : 8400193, Houston

78006

TTS Research- Site Number : 8400012, Boerne

78215

Sun Research Institute - Site Number : 8400183, San Antonio

80219

Allianz Research Institute Colorado Site Number : 8400061, Denver

83022

Investigational Site Number : 2760011, Rosenheim

84123

AES Salt Lake City- Site Number : 8400332, Murray

85020

Synexus Phoenix Central (Central Phoenix Medical Clinic)- Site Number : 8400333, Phoenix

89106

Sierra Clinical Research- Site Number : 8400005, Las Vegas

91031

Investigational Site Number : 3760003, Jerusalem

91120

Investigational Site Number : 3760002, Jerusalem

91910

Investigational Site Number : 4840004, Veracruz

92231

Investigational Site Number : 4400003, Klaipėda

92262

Palmtree Clinical Research Site Number : 8400184, Palm Springs

92590

Inspire Pulmonary & Sleep Medicine Specialists Site Number : 8400232, Temecula

93701

UCSF Fresno - Site Number : 8400030, Fresno

97227

Kaiser Permanente Center for Health Research Site Number : 8400039, Portland

105077

Investigational Site Number : 6430002, Moscow

115093

Investigational Site Number : 6430001, Moscow

115280

Investigational Site Number : 6430005, Moscow

160012

Investigational Site Number : 3560001, Chandigarh

193231

Investigational Site Number : 6430004, Saint Petersburg

194354

Investigational Site Number : 6430003, Saint Petersburg

208002

Investigational Site Number : 3560019, Kanpur

302023

Investigational Site Number : 3560013, Jaipur

411004

Investigational Site Number : 3560012, Pune

411057

Investigational Site Number : 3560018, Pune

422007

Investigational Site Number : 3560009, Nashik

432017

Investigational Site Number : 6430006, Ulyanovsk

440010

Investigational Site Number : 3560014, India

440012

Investigational Site Number : 3560017, Nagpur

440015

Investigational Site Number : 3560005, Nagpur

590010

Investigational Site Number : 3560016, Belagavi

700107

Investigational Site Number : 3560010, Kolkata

2260877

Investigational Site Number : 1520006, Quillota

5110683

Investigational Site Number : 1520009, Valdivia

5266202

Investigational Site Number : 3760009, Ramat Gan

7500010

Investigational Site Number : 1520007, Santiago

7500587

Investigational Site Number : 1520008, Santiago

7500692

Investigational Site Number : 1520001, Santiago

7500698

Investigational Site Number : 1520003, Santiago

8910131

Investigational Site Number : 1520005, Santiago

02110

Care Access Site Number : 8400276, Boston

Care Access Site Number : 8400281, Boston

19140-5103

Temple University Hospital Site Number : 8400062, Philadelphia

76550-1820

Radiance Clinical Research- Site Number : 8400037, Lampasas

CP 1884

Investigational Site Number : 0320009, Berazategui

C1023AAB

Investigational Site Number : 0320008, CABA

C1414AIF

Investigational Site Number : 0320001, CABA

B2700CPM

Investigational Site Number : 0320005, Pergamino

B1602DQD

Investigational Site Number : 0320002, Vicente Lopez

S2000DBS

Investigational Site Number : 0320003, Rosario

S2000JKR

Investigational Site Number : 0320004, Rosario

29055 450

CEDOES - Centro de Diagnostico e Pesquisa de Osteoporose do ES- Site Number : 0760009, Vitória

40150-150

SER da Bahia- Site Number : 0760020, Salvador

70710-100

CECAP - Centro de Cardiologia Clinica e Pesquisa Dra. Juliana Souza- Site Number : 0760018, Brasília

65060-645

Hospital Sao Domingos- Site Number : 0760016, São Luís

30150-221

Santa Casa de Belo Horizonte - Hospital Emygdio Germano- Site Number : 0760014, Belo Horizonte

80060-240

CETI - Centro de Estudos em Terapias Inovadoras- Site Number : 0760012, Curitiba

90020-090

Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001, Porto Alegre

90480-020

Instituto Ceos Site Number : 0760021, Porto Alegre

90610-000

Hospital Sao Lucas da PUCRS- Site Number : 0760007, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao- Site Number : 0760006, Porto Alegre

18618-687

Faculdade de Medicina da Universidade Estadual Paulista- Site Number : 0760005, Botucatu

13059-900

PUC Campinas - Sociedade Campineira de Educaçao e Instruçao- Site Number : 0760010, Campinas

09715-090

CEMEC - Centro Multidisciplinar de Estudos Clinicos- Site Number : 0760015, São Bernardo do Campo

04014-002

Nucleo de Pesquisa Clinica e Ensino da Rede Sao Camilo- Site Number : 0760013, São Paulo

18040-425

Clinica de Alergia Martti Antila Site Number : 0760008, Sorocaba

20241-180

Instituto Brasil de Pesquisa Clínica-IBPCLIN S/A Site Number : 0760017, Rio de Janeiro

04266-010

CEPIC - Centro Paulista de Investigação Clínica- Site Number : 0760004, São Paulo

T8H 0N2

Investigational Site Number : 1240006, Sherwood Park

V1Y 4N7

Investigational Site Number : 1240014, Kelowna

V2A 5L5

Investigational Site Number : 1240016, Penticton

E1C2Z3

Investigational Site Number : 1240012, Moncton

L1S 2J5

Investigational Site Number : 1240021, Ajax

L7N 3V2

Investigational Site Number : 1240020, Burlington

N1H 6J2

Investigational Site Number : 1240023, Guelph

M5T 3A9

Investigational Site Number : 1240009, Toronto

N8X 1T3

Investigational Site Number : 1240022, Windsor

N8X 5A6

Investigational Site Number : 1240018, Windsor

J1H 5N4

Investigational Site Number : 1240004, Sherbrooke

J6E 2B4

Investigational Site Number : 1240005, St-charles Borrommee

J6V 2H2

Investigational Site Number : 1240019, Terrebonne

G8T 7A1

Investigational Site Number : 1240001, Trois-Rivières

G6P 3Z8

Investigational Site Number : 1240002, Victoriaville

G1N 4V3

Investigational Site Number : 1240003, Québec

Unknown

Investigational Site Number : 1520002, Talca

Investigational Site Number : 2500002, Montpellier

250 64

Investigational Site Number : 2030009, Měšice

779 00

Investigational Site Number : 2030008, Olomouc

140 46

Investigational Site Number : 2030002, Prague

415 01

Investigational Site Number : 2030006, Teplice

0160

Investigational Site Number : 2680001, Tbilisi

0168

Investigational Site Number : 2680002, Tbilisi

04299

Investigational Site Number : 2760008, Leipzig

04347

Investigational Site Number : 2760007, Leipzig

455-8530

Investigational Site Number : 3920023, Nagoya

457-8511

Investigational Site Number : 3920020, Nagoya

815-0032

Investigational Site Number : 3920005, Fukuoka

819-8555

Investigational Site Number : 3920027, Fukuoka

830-0011

Investigational Site Number : 3920030, Kurume-shi

509-6134

Investigational Site Number : 3920015, Mizunami-shi

734-8530

Investigational Site Number : 3920010, Hiroshima

737-0193

Investigational Site Number : 3920021, Kure-shi

737-8505

Investigational Site Number : 3920035, Kure-shi

006-8555

Investigational Site Number : 3920038, Sapporo

064-0804

Investigational Site Number : 3920042, Sapporo

670-0849

Investigational Site Number : 3920013, Himeji-shi

762-8550

Investigational Site Number : 3920009, Sakaide-shi

761-8073

Investigational Site Number : 3920014, Takamatsu

234-0054

Investigational Site Number : 3920011, Konan-ku, Yokohama-shi

223-0059

Investigational Site Number : 3920039, Yokohama

515-8544

Investigational Site Number : 3920043, Matsusaka-shi

530-8480

Investigational Site Number : 3920003, Osaka

545-8586

Investigational Site Number : 3920026, Osaka

591-8555

Investigational Site Number : 3920007, Sakai-shi

581-0011

Investigational Site Number : 3920006, Yao-shi

327-8511

Investigational Site Number : 3920036, Sano-shi

103-0022

Investigational Site Number : 3920040, Chuo-ku

104-0031

Investigational Site Number : 3920017, Chuo-ku

Investigational Site Number : 3920024, Chuo-ku

173-8610

Investigational Site Number : 3920019, Itabashi-ku

204-8522

Investigational Site Number : 3920029, Kiyose

150-8935

Investigational Site Number : 3920025, Shibuya-ku

140-8522

Investigational Site Number : 3920016, Shinagawa-ku

142-8666

Investigational Site Number : 3920037, Shinagawa-ku

170-0003

Investigational Site Number : 3920041, Toshima-ku

LV-5417

Investigational Site Number : 4280002, Daugavpils

LV-1002

Investigational Site Number : 4280001, Riga

6815 AD

Investigational Site Number : 5280005, Arnhem

4818 CK

Investigational Site Number : 5280001, Breda

7207 AE

Investigational Site Number : 5280008, Zutphen

05-200

Investigational Site Number : 6160005, Wołomin

15-044

Investigational Site Number : 6160008, Bialystok

82-200

Investigational Site Number : 6160003, Malbork

40-611

Investigational Site Number : 6160002, Katowice

27-400

Investigational Site Number : 6160009, Ostrowiec Świętokrzyski

2801-951

Investigational Site Number : 6200009, Almada

3810-501

Investigational Site Number : 6200006, Aveiro

4710-243

Investigational Site Number : 6200002, Braga

4810-061

Investigational Site Number : 6200001, Guimarães

4464-513

Investigational Site Number : 6200010, Matosinhos Municipality

00968

Cardiopulmonary Research- Site Number : 8400040, Guaynabo

00717-1322

BRCR Medical Center, Inc. Site Number : 8400190, Ponce

00907

BRCR Medical Center Site Number : 8400180, San Juan

0145

Investigational Site Number : 7100009, Pretoria

463-707

Investigational Site Number : 4100005, Seongnam-si

05030

Investigational Site Number : 4100004, Seoul

06591

Investigational Site Number : 4100001, Seoul

07120

Investigational Site Number : 7240004, Palma de Mallorca

08017

Investigational Site Number : 7240014, Barcelona

08830

Investigational Site Number : 7240006, Sant Boi de Llobregat

06800

Investigational Site Number : 7240002, Mérida / Badajoz

06100

Investigational Site Number : 7920007, Ankara

01330

Investigational Site Number : 7920005, Balcali Adana

ML2 0DP

Investigational Site Number : 8260006, Wishaw

NE29 8NH

Investigational Site Number : 8260007, Tyne and Wear

KT16 0PZ

Investigational Site Number : 8260002, Chertsey

BD9 6RJ

Investigational Site Number : 8260003, Bradford

L143PE

Investigational Site Number : 8260005, Liverpool

MK15 0DU

Investigational Site Number : 8260008, Milton Keynes

NE4 6BE

Investigational Site Number : 8260001, Newcastle upon Tyne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT04751487 - Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter