A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

January 11, 2024

Primary Completion Date

December 1, 2026

Study Completion Date

December 1, 2026

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 (223)

110

Investigational Site Number : 1580003, Taipei

404

Investigational Site Number : 1580006, Taichung

807

Investigational Site Number : 1580005, Kaohsiung City

1023

Investigational Site Number : 0320010, Buenos Aires

1106

Investigational Site Number : 3480009, Budapest

1142

Investigational Site Number : 1000016, Sofia

1233

Investigational Site Number : 1000001, Sofia

1414

Investigational Site Number : 0320005, Buenos Aires

1425

Investigational Site Number : 0320002, Buenos Aires

1478

Investigational Site Number : 5780001, Lørenskog

1500

Investigational Site Number : 7100004, Benoni

1638

Investigational Site Number : 0320006, Buenos Aires

1650

Investigational Site Number : 0320009, Buenos Aires

1756

Investigational Site Number : 1000009, Sofia

1886

Investigational Site Number : 0320012, Berazategui

2000

Investigational Site Number : 0320003, Rosario

Investigational Site Number : 0320007, Rosario

Investigational Site Number : 0320008, Rosario

Investigational Site Number : 0320011, Rosario

2100

Investigational Site Number : 3480001, Gödöllő

3700

Investigational Site Number : 1000006, Vidin

4001

Investigational Site Number : 7100001, Durban

Investigational Site Number : 7100006, Durban

4080

Investigational Site Number : 3480004, Hajdúnánás

4150

Investigational Site Number : 3480003, Püspökladány

4302

Investigational Site Number : 7100005, Durban

5000

Investigational Site Number : 1000013, Veliko Tarnovo

5300

Investigational Site Number : 1000004, Gabrovo

5500

Investigational Site Number : 0320004, Mendoza

6000

Investigational Site Number : 1000017, Stara Zagora

6003

Investigational Site Number : 1000003, Stara Zagora

6010

Investigational Site Number : 2680006, Batumi

6300

Investigational Site Number : 1000007, Haskovo

7000

Investigational Site Number : 1000018, Rousse

7002

Investigational Site Number : 1000010, Rousse

9200

Investigational Site Number : 3480002, Mosonmagyaróvár

12159

Investigational Site Number : 2760010, Berlin

12308

Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029, Schenectady

14215

VA Western New York Healthcare System Site Number : 8402050, Buffalo

15212

Allegheny General Hospital- Site Number : 8402058, Pittsburgh

15801

Clinical Research Associates of Central PA - Dubois- Site Number : 8401023, DuBois

23552

Investigational Site Number : 2760003, Lübeck

25801

Rheumatology & Pulmonary Clinic- Site Number : 8402053, Beckley

26426

Investigational Site Number : 4100002, Wŏnju

27858

East Carolina University- Site Number : 8401022, Greenville

28007

Investigational Site Number : 7240003, Madrid

28040

Investigational Site Number : 7240007, Madrid

28078

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

28223

Investigational Site Number : 7240008, Pozuelo de Alarcón

29010

Investigational Site Number : 7240001, Málaga

29204

MedTrial- Site Number : 8402048, Columbia

29732

Clinical Research of Rock Hill Site Number : 8401008, Rock Hill

30344

Covenant Pulmonary Critical Care Site Number : 8401183, East Point

30350

Alpha Clinical Research Group - Dunwoody- Site Number : 8401190, Dunwoody

30701

Appalachian Clinical Research Site Number : 8400024, Calhoun

31015

Private Practice - Dr. David Kavtaradze- Site Number : 8401029, Cordele

32159

Premier Medical Associates Site Number : 8401388, Lady Lake

32713

Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031, DeBary

32765

Oviedo Medical Research Site Number : 8402026, Oviedo

32819

Heuer M.D. Research- Site Number : 8402016, Orlando

32825

Florida Institute for Clinical Research Site Number : 8401013, Orlando

33012

Direct Helpers Research Center- Site Number : 8402065, Hialeah

33014

Deluxe Health Center Site Number : 8401188, Miami Lakes

33024

Pines Care Research Center- Site Number : 8402056, Pembroke Pines

33025

Tellabio International Research Services Site Number : 8401411, Pembroke Pines

33070

Investigational Site Number : 7920002, Akdeniz

33126

Finlay Medical Research- Site Number : 8402007, Miami

33144

Elite Clinical Research - Miami- Site Number : 8402009, Miami

33155

DL Research Solutions- Site Number : 8401033, Miami

My Community Research Center Site Number : 8402060, Miami

33157

Beautiful Minds Clinical Research Center Site Number : 8401201, Cutler Bay

Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067, Palmetto Bay

33165

Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019, Miami

33173

Research Institute of South Florida- Site Number : 8401006, Miami

33176

Reed Medical Research Site Number : 8401032, Miami

33178

Science Connections, LLC Site Number : 8402045, Doral

33184

High Quality Research Site Number : 8401406, Miami

33435

Helix Biomedics- Site Number : 8402049, Boynton Beach

33470

Advanced Pulmonary Research Institute Site Number : 8402018, Loxahatchee Groves

33606

Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008, Tampa

34000

Investigational Site Number : 4840007, Durango

34098

Investigational Site Number : 7920001, Istanbul

34470

Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015, Ocala

44100

Investigational Site Number : 3800001, Ferrara

48076

Revive Research Institute - Lathrup Village- Site Number : 8402186, Lathrup Village

48088

Pulmonary and Medicine Associates- Site Number : 8401403, Warren

49449

Investigational Site Number : 4400002, Kaunas

50009

Investigational Site Number : 7240012, Zaragoza

50406

Investigational Site Number : 2330001, Tartu

51092

Investigational Site Number : 2500004, Reims

55128

Investigational Site Number : 2760001, Mainz

56170

Investigational Site Number : 2760006, Bendorf

60596

Investigational Site Number : 2760005, Frankfurt

61637

OSF Saint Fracis Medical Center- Site Number : 8402024, Peoria

63110

Washington University- Site Number : 8402035, St Louis

63301

Midwest Chest Consultants- Site Number : 8401002, Saint Charles

69004

Investigational Site Number : 2500001, Lyon

70433

Benchmark Research - Covington- Site Number : 8401193, Covington

71100

Investigational Site Number : 7920006, Kırıkkale

71105

Care Access - Shreveport- Site Number : 8402047, Shreveport

73034

OK Clinical Research- Site Number : 8402001, Edmond

75007

ClinRx Research - Carrollton- Site Number : 8401021, Carrollton

75069

Metroplex Pulmonary and Sleep Center Site Number : 8401015, McKinney

75110

Corsicana Medical Research- Site Number : 8401018, Corsicana

77030

The Methodist Hospital Research Institute Site Number : 8401194, Houston

77598

Clear Lake Specialties Research Center, PLLC Site Number : 8401025, Webster

77701

REX Clinical Trials - Beaumont- Site Number : 8401371, Beaumont

78006

South Texas Medical Research Institute - TTS Research- Site Number : 8402012, Boerne

80014

Allianz Research Institute CO Site Number : 8402061, Aurora

80301

Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180, Boulder

83022

Investigational Site Number : 2760011, Rosenheim

85224

Chandler Clinical Research Trials- Site Number : 8401034, Chandler

85704

Noble Clinical Research Site Number : 8401182, Tucson

85712

Tucson Clinical Research Institute- Site Number : 8401431, Tucson

89052

Henderson Clinical Trials Site Number : 8401365, Henderson

90017

Downtown L.A. Research Center- Site Number : 8401027, Los Angeles

90623

IMAX Clinical Trials- Site Number : 8401419, La Palma

93534

Antelope Valley Clinical Trials Site Number : 8401003, Lancaster

100038

Investigational Site Number : 1560012, Beijing

110004

Investigational Site Number : 1560008, Shenyang

130021

Investigational Site Number : 1560004, Changchun

160012

Investigational Site Number : 3560006, Chandigarh

200025

Investigational Site Number : 1560020, Shanghai

200433

Investigational Site Number : 1560006, Shanghai

208001

Investigational Site Number : 3560012, Kanpur

221006

Investigational Site Number : 1560007, Xuzhou

225000

Investigational Site Number : 1560015, Yangzhou

230032

Investigational Site Number : 1560016, Hefei

250014

Investigational Site Number : 1560002, Jinan

302023

Investigational Site Number : 3560009, Jaipur

302039

Investigational Site Number : 3560004, Jaipur

330006

Investigational Site Number : 1560014, Nanchang

337055

Investigational Site Number : 1560019, Pingxiang

400275

Investigational Site Number : 6420002, Cluj-Napoca

411057

Investigational Site Number : 3560013, Pune

411100

Investigational Site Number : 1560011, Xiangtan

430014

Investigational Site Number : 1560005, Wuhan

440010

Investigational Site Number : 3560010, Nagpur

440012

Investigational Site Number : 3560011, Nagpur

440015

Investigational Site Number : 3560007, Nagpur

441203

Investigational Site Number : 3560003, Nagpur

570216

Investigational Site Number : 1560018, Haikou

610041

Investigational Site Number : 1560001, Chengdu

673008

Investigational Site Number : 3560001, Calicut

2260877

Investigational Site Number : 1520005, Quillota

3436212

Investigational Site Number : 3760008, Haifa

3465584

Investigational Site Number : 1520006, Talca

4428164

Investigational Site Number : 3760006, Kefar Sava

4941492

Investigational Site Number : 3760001, Petah Tikva

5110683

Investigational Site Number : 1520008, Valdivia

5262100

Investigational Site Number : 3760009, Ramat Gan

6423906

Investigational Site Number : 3760007, Tel Aviv

7500010

Investigational Site Number : 1520007, Santiago

7500692

Investigational Site Number : 1520001, Santiago

7500698

Investigational Site Number : 1520003, Santiago

7610001

Investigational Site Number : 3760004, Rehovot

7750000

Investigational Site Number : 1520002, Santiago

9103102

Investigational Site Number : 3760003, Jerusalem

9112001

Investigational Site Number : 3760002, Jerusalem

04401

Private Practice - Dr. Paul Shapero- Site Number : 8401016, Bangor

02110

Care Access - Boston- Site Number : 8402276, Boston

63401-6890

Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383, Hannibal

B1900BNN

Investigational Site Number : 0320013, La Plata

29055-450

Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760009, Vitória

40150-150

Serviços Especializados em Reumatologia- Site Number : 0760020, Salvador

70710-100

Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018, Brasília

30150-221

Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014, Belo Horizonte

80030-110

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

90020-090

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

90480-020

Instituto Ceos Site Number : 0760021, Porto Alegre

90610-000

Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007, Porto Alegre

91010-006

WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006, Porto Alegre

18618-970

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

13034-685

Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010, Campinas

09715-090

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

04014-002

Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760013, São Paulo

T8H 0N2

Investigational Site Number : 1240006, Sherwood Park

L1S 2J5

Investigational Site Number : 1240021, Ajax

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

G8T 7A1

Investigational Site Number : 1240001, Trois-Rivières

G6P 3Z8

Investigational Site Number : 1240002, Victoriaville

010050

Investigational Site Number : 1560017, Hohhot

580 01

Investigational Site Number : 2030003, Havlíčkův Brod

377 01

Investigational Site Number : 2030001, Jindřichův Hradec

0105

Investigational Site Number : 2680002, Tbilisi

0112

Investigational Site Number : 2680003, Tbilisi

0159

Investigational Site Number : 2680001, Tbilisi

04299

Investigational Site Number : 2760008, Leipzig

04347

Investigational Site Number : 2760007, Leipzig

175 62

Investigational Site Number : 3000008, Palaió Fáliro

570 10

Investigational Site Number : 3000002, Thessaloniki

500 084

Investigational Site Number : 3560005, Hyderabad

457-8511

Investigational Site Number : 3920008, Nagoya

830-0011

Investigational Site Number : 3920002, Kurume

737-0811

Investigational Site Number : 3920007, Kure

670-0849

Investigational Site Number : 3920006, Himeji

234-0054

Investigational Site Number : 3920009, Yokohama

515-0073

Investigational Site Number : 3920001, Matsusaka

204-8522

Investigational Site Number : 3920005, Kiyose

819-0055

Investigational Site Number : 3920003, Fukuoka

140-8522

Investigational Site Number : 3920004, Tokyo

4818 CK

Investigational Site Number : 5280001, Breda

15-044

Investigational Site Number : 6160001, Bialystok

27-400

Investigational Site Number : 6160002, Ostrowiec Świętokrzyski

3814-501

Investigational Site Number : 6200006, Porto

066 01

Investigational Site Number : 7030002, Humenné

080 01

Investigational Site Number : 7030004, Prešov

052 01

Investigational Site Number : 7030003, Spišská Nová Ves

05030

Investigational Site Number : 4100001, Seoul

08017

Investigational Site Number : 7240014, Barcelona

08830

Investigational Site Number : 7240006, Sant Boi de Llobregat

07120

Investigational Site Number : 7240004, Palma

06230

Investigational Site Number : 7920007, Ankara

PO6 3LY

Investigational Site Number : 8260004, Portsmouth

KT16 0PZ

Investigational Site Number : 8260002, Chertsey

BD9 6RJ

Investigational Site Number : 8260003, Bradford

TW5 9ER

Investigational Site Number : 8260014, Hounslow

L14 3PE

Investigational Site Number : 8260005, Liverpool

EC1M 6BQ

Investigational Site Number : 8260010, London

MK15 0DU

Investigational Site Number : 8260008, Milton Keynes

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY

NCT06208306 - A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD | Biotech Hunter | Biotech Hunter