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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
669
Start Date
2024-01-11
Completion Date
2026-09-10
Last Updated
2026-09-18
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