Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Sponsor: Sanofi
Summary
This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments. The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819. Study details include: * The study duration will be up to 72 weeks * The treatment duration will be up to 52 weeks * A follow-up period of 20 weeks will be conducted * The number of on-site visits will be 7 and the number of phone contacts will be 5
Official title: A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2024-01-11
Completion Date
2026-12-01
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Itepekimab (SAR440340)
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
Placebo
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
Locations (223)
Chandler Clinical Research Trials- Site Number : 8401034
Chandler, Arizona, United States
Noble Clinical Research Site Number : 8401182
Tucson, Arizona, United States
Tucson Clinical Research Institute- Site Number : 8401431
Tucson, Arizona, United States
IMAX Clinical Trials- Site Number : 8401419
La Palma, California, United States
Antelope Valley Clinical Trials Site Number : 8401003
Lancaster, California, United States
Downtown L.A. Research Center- Site Number : 8401027
Los Angeles, California, United States
Allianz Research Institute CO Site Number : 8402061
Aurora, Colorado, United States
Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
Boulder, Colorado, United States
Helix Biomedics- Site Number : 8402049
Boynton Beach, Florida, United States
Beautiful Minds Clinical Research Center Site Number : 8401201
Cutler Bay, Florida, United States
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
DeBary, Florida, United States
Science Connections, LLC Site Number : 8402045
Doral, Florida, United States
Direct Helpers Research Center- Site Number : 8402065
Hialeah, Florida, United States
Premier Medical Associates Site Number : 8401388
Lady Lake, Florida, United States
Advanced Pulmonary Research Institute Site Number : 8402018
Loxahatchee Groves, Florida, United States
Finlay Medical Research- Site Number : 8402007
Miami, Florida, United States
Elite Clinical Research - Miami- Site Number : 8402009
Miami, Florida, United States
DL Research Solutions- Site Number : 8401033
Miami, Florida, United States
My Community Research Center Site Number : 8402060
Miami, Florida, United States
Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
Miami, Florida, United States
Research Institute of South Florida- Site Number : 8401006
Miami, Florida, United States
Reed Medical Research Site Number : 8401032
Miami, Florida, United States
High Quality Research Site Number : 8401406
Miami, Florida, United States
Deluxe Health Center Site Number : 8401188
Miami Lakes, Florida, United States
Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
Ocala, Florida, United States
Heuer M.D. Research- Site Number : 8402016
Orlando, Florida, United States
Florida Institute for Clinical Research Site Number : 8401013
Orlando, Florida, United States
Oviedo Medical Research Site Number : 8402026
Oviedo, Florida, United States
Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
Palmetto Bay, Florida, United States
Pines Care Research Center- Site Number : 8402056
Pembroke Pines, Florida, United States
Tellabio International Research Services Site Number : 8401411
Pembroke Pines, Florida, United States
Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
Tampa, Florida, United States
Appalachian Clinical Research Site Number : 8400024
Calhoun, Georgia, United States
Private Practice - Dr. David Kavtaradze- Site Number : 8401029
Cordele, Georgia, United States
Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
Dunwoody, Georgia, United States
Covenant Pulmonary Critical Care Site Number : 8401183
East Point, Georgia, United States
OSF Saint Fracis Medical Center- Site Number : 8402024
Peoria, Illinois, United States
Benchmark Research - Covington- Site Number : 8401193
Covington, Louisiana, United States
Care Access - Shreveport- Site Number : 8402047
Shreveport, Louisiana, United States
Private Practice - Dr. Paul Shapero- Site Number : 8401016
Bangor, Maine, United States
Care Access - Boston- Site Number : 8402276
Boston, Massachusetts, United States
Revive Research Institute - Lathrup Village- Site Number : 8402186
Lathrup Village, Michigan, United States
Pulmonary and Medicine Associates- Site Number : 8401403
Warren, Michigan, United States
Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
Hannibal, Missouri, United States
Midwest Chest Consultants- Site Number : 8401002
Saint Charles, Missouri, United States
Washington University- Site Number : 8402035
St Louis, Missouri, United States
Henderson Clinical Trials Site Number : 8401365
Henderson, Nevada, United States
VA Western New York Healthcare System Site Number : 8402050
Buffalo, New York, United States
Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029
Schenectady, New York, United States
East Carolina University- Site Number : 8401022
Greenville, North Carolina, United States
Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
Huntersville, North Carolina, United States
OK Clinical Research- Site Number : 8402001
Edmond, Oklahoma, United States
Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
DuBois, Pennsylvania, United States
Allegheny General Hospital- Site Number : 8402058
Pittsburgh, Pennsylvania, United States
MedTrial- Site Number : 8402048
Columbia, South Carolina, United States
Clinical Research of Rock Hill Site Number : 8401008
Rock Hill, South Carolina, United States
REX Clinical Trials - Beaumont- Site Number : 8401371
Beaumont, Texas, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8402012
Boerne, Texas, United States
ClinRx Research - Carrollton- Site Number : 8401021
Carrollton, Texas, United States
Corsicana Medical Research- Site Number : 8401018
Corsicana, Texas, United States
The Methodist Hospital Research Institute Site Number : 8401194
Houston, Texas, United States
Metroplex Pulmonary and Sleep Center Site Number : 8401015
McKinney, Texas, United States
Clear Lake Specialties Research Center, PLLC Site Number : 8401025
Webster, Texas, United States
Rheumatology & Pulmonary Clinic- Site Number : 8402053
Beckley, West Virginia, United States
Investigational Site Number : 0320012
Berazategui, Buenos Aires, Argentina
Investigational Site Number : 0320013
La Plata, Buenos Aires, Argentina
Investigational Site Number : 0320003
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320007
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320008
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320011
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320010
Buenos Aires, Argentina
Investigational Site Number : 0320005
Buenos Aires, Argentina
Investigational Site Number : 0320002
Buenos Aires, Argentina
Investigational Site Number : 0320006
Buenos Aires, Argentina
Investigational Site Number : 0320009
Buenos Aires, Argentina
Investigational Site Number : 0320004
Mendoza, Argentina
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760009
Vitória, Espírito Santo, Brazil
Serviços Especializados em Reumatologia- Site Number : 0760020
Salvador, Estado de Bahia, Brazil
Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018
Brasília, Federal District, Brazil
Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014
Belo Horizonte, Minas Gerais, Brazil
Centro de Estudos em Terapias Inovadoras- Site Number : 0760012
Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Ceos Site Number : 0760021
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007
Porto Alegre, Rio Grande do Sul, Brazil
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006
Porto Alegre, Rio Grande do Sul, Brazil
Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760005
Botucatu, São Paulo, Brazil
Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010
Campinas, São Paulo, Brazil
Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015
São Bernardo do Campo, São Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760013
São Paulo, Brazil
Investigational Site Number : 1000004
Gabrovo, Bulgaria
Investigational Site Number : 1000007
Haskovo, Bulgaria
Investigational Site Number : 1000018
Rousse, Bulgaria
Investigational Site Number : 1000010
Rousse, Bulgaria
Investigational Site Number : 1000016
Sofia, Bulgaria
Investigational Site Number : 1000001
Sofia, Bulgaria
Investigational Site Number : 1000009
Sofia, Bulgaria
Investigational Site Number : 1000017
Stara Zagora, Bulgaria
Investigational Site Number : 1000003
Stara Zagora, Bulgaria
Investigational Site Number : 1000013
Veliko Tarnovo, Bulgaria
Investigational Site Number : 1000006
Vidin, Bulgaria
Investigational Site Number : 1240006
Sherwood Park, Alberta, Canada
Investigational Site Number : 1240021
Ajax, Ontario, Canada
Investigational Site Number : 1240009
Toronto, Ontario, Canada
Investigational Site Number : 1240022
Windsor, Ontario, Canada
Investigational Site Number : 1240018
Windsor, Ontario, Canada
Investigational Site Number : 1240004
Sherbrooke, Quebec, Canada
Investigational Site Number : 1240001
Trois-Rivières, Quebec, Canada
Investigational Site Number : 1240002
Victoriaville, Quebec, Canada
Investigational Site Number : 1520008
Valdivia, Los Ríos Region, Chile
Investigational Site Number : 1520006
Talca, Maule Region, Chile
Investigational Site Number : 1520007
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520005
Quillota, Región de Valparaíso, Chile
Investigational Site Number : 1560012
Beijing, China
Investigational Site Number : 1560004
Changchun, China
Investigational Site Number : 1560001
Chengdu, China
Investigational Site Number : 1560018
Haikou, China
Investigational Site Number : 1560016
Hefei, China
Investigational Site Number : 1560017
Hohhot, China
Investigational Site Number : 1560002
Jinan, China
Investigational Site Number : 1560014
Nanchang, China
Investigational Site Number : 1560019
Pingxiang, China
Investigational Site Number : 1560020
Shanghai, China
Investigational Site Number : 1560006
Shanghai, China
Investigational Site Number : 1560008
Shenyang, China
Investigational Site Number : 1560005
Wuhan, China
Investigational Site Number : 1560011
Xiangtan, China
Investigational Site Number : 1560007
Xuzhou, China
Investigational Site Number : 1560015
Yangzhou, China
Investigational Site Number : 2030003
Havlíčkův Brod, Czechia
Investigational Site Number : 2030001
Jindřichův Hradec, Czechia
Investigational Site Number : 2330001
Tartu, Estonia
Investigational Site Number : 2500001
Lyon, France
Investigational Site Number : 2500004
Reims, France
Investigational Site Number : 2680006
Batumi, Georgia
Investigational Site Number : 2680002
Tbilisi, Georgia
Investigational Site Number : 2680003
Tbilisi, Georgia
Investigational Site Number : 2680001
Tbilisi, Georgia
Investigational Site Number : 2760006
Bendorf, Germany
Investigational Site Number : 2760010
Berlin, Germany
Investigational Site Number : 2760005
Frankfurt, Germany
Investigational Site Number : 2760008
Leipzig, Germany
Investigational Site Number : 2760007
Leipzig, Germany
Investigational Site Number : 2760003
Lübeck, Germany
Investigational Site Number : 2760001
Mainz, Germany
Investigational Site Number : 2760011
Rosenheim, Germany
Investigational Site Number : 3000008
Palaió Fáliro, Greece
Investigational Site Number : 3000002
Thessaloniki, Greece
Investigational Site Number : 3480009
Budapest, Hungary
Investigational Site Number : 3480001
Gödöllő, Hungary
Investigational Site Number : 3480004
Hajdúnánás, Hungary
Investigational Site Number : 3480002
Mosonmagyaróvár, Hungary
Investigational Site Number : 3480003
Püspökladány, Hungary
Investigational Site Number : 3560001
Calicut, India
Investigational Site Number : 3560006
Chandigarh, India
Investigational Site Number : 3560005
Hyderabad, India
Investigational Site Number : 3560009
Jaipur, India
Investigational Site Number : 3560004
Jaipur, India
Investigational Site Number : 3560012
Kanpur, India
Investigational Site Number : 3560010
Nagpur, India
Investigational Site Number : 3560011
Nagpur, India
Investigational Site Number : 3560007
Nagpur, India
Investigational Site Number : 3560003
Nagpur, India
Investigational Site Number : 3560013
Pune, India
Investigational Site Number : 3760008
Haifa, Israel
Investigational Site Number : 3760003
Jerusalem, Israel
Investigational Site Number : 3760002
Jerusalem, Israel
Investigational Site Number : 3760006
Kefar Sava, Israel
Investigational Site Number : 3760001
Petah Tikva, Israel
Investigational Site Number : 3760009
Ramat Gan, Israel
Investigational Site Number : 3760004
Rehovot, Israel
Investigational Site Number : 3760007
Tel Aviv, Israel
Investigational Site Number : 3800001
Ferrara, Italy
Investigational Site Number : 3920008
Nagoya, Aichi-ken, Japan
Investigational Site Number : 3920002
Kurume, Fukuoka, Japan
Investigational Site Number : 3920007
Kure, Hiroshima, Japan
Investigational Site Number : 3920006
Himeji, Hyōgo, Japan
Investigational Site Number : 3920009
Yokohama, Kanagawa, Japan
Investigational Site Number : 3920001
Matsusaka, Mie-ken, Japan
Investigational Site Number : 3920005
Kiyose, Tokyo, Japan
Investigational Site Number : 3920003
Fukuoka, Japan
Investigational Site Number : 3920004
Tokyo, Japan
Investigational Site Number : 4400002
Kaunas, Lithuania
Investigational Site Number : 4840007
Durango, Mexico
Investigational Site Number : 5280001
Breda, Netherlands
Investigational Site Number : 5780001
Lørenskog, Norway
Investigational Site Number : 6160001
Bialystok, Podlaskie Voivodeship, Poland
Investigational Site Number : 6160002
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
Investigational Site Number : 6200006
Porto, Portugal
Investigational Site Number : 6420002
Cluj-Napoca, Romania
Investigational Site Number : 7030002
Humenné, Slovakia
Investigational Site Number : 7030004
Prešov, Slovakia
Investigational Site Number : 7030003
Spišská Nová Ves, Slovakia
Investigational Site Number : 7100004
Benoni, South Africa
Investigational Site Number : 7100001
Durban, South Africa
Investigational Site Number : 7100006
Durban, South Africa
Investigational Site Number : 7100005
Durban, South Africa
Investigational Site Number : 4100002
Wŏnju, Gangwon-do, South Korea
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, South Korea
Investigational Site Number : 7240014
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240006
Sant Boi de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240008
Pozuelo de Alarcón, Madrid, Spain
Investigational Site Number : 7240003
Madrid, Spain
Investigational Site Number : 7240007
Madrid, Spain
Investigational Site Number : 7240001
Málaga, Spain
Investigational Site Number : 7240004
Palma, Spain
Investigational Site Number : 7240012
Zaragoza, Spain
Investigational Site Number : 1580005
Kaohsiung City, Taiwan
Investigational Site Number : 1580006
Taichung, Taiwan
Investigational Site Number : 1580003
Taipei, Taiwan
Investigational Site Number : 7920002
Akdeniz, Turkey (Türkiye)
Investigational Site Number : 7920007
Ankara, Turkey (Türkiye)
Investigational Site Number : 7920001
Istanbul, Turkey (Türkiye)
Investigational Site Number : 7920006
Kırıkkale, Turkey (Türkiye)
Investigational Site Number : 8260004
Portsmouth, Hampshire, United Kingdom
Investigational Site Number : 8260002
Chertsey, Surrey, United Kingdom
Investigational Site Number : 8260003
Bradford, United Kingdom
Investigational Site Number : 8260014
Hounslow, United Kingdom
Investigational Site Number : 8260005
Liverpool, United Kingdom
Investigational Site Number : 8260010
London, United Kingdom
Investigational Site Number : 8260008
Milton Keynes, United Kingdom