En undersøgelse for at undersøge langsigtet sikkerhed og tolerabilitet af Itepekimab hos deltagere med KOL (AERIFY-4)
16. september 2026 opdateret af: Sanofi
Et dobbeltblindet forlængelsesstudie til evaluering af itepekimabs langsigtede sikkerhed og tolerabilitet hos patienter med kronisk obstruktiv lungesygdom (KOL), som deltog i enten EFC16750 eller EFC16819 kliniske undersøgelser
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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
669
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, 1425
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1023
- Investigational Site Number : 0320010
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Buenos Aires, Argentina, 1414
- Investigational Site Number : 0320005
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Buenos Aires, Argentina, 1638
- Investigational Site Number : 0320006
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Buenos Aires, Argentina, 1650
- Investigational Site Number : 0320009
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Mendoza, Argentina, 5500
- Investigational Site Number : 0320004
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Buenos Aires
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Berazategui, Buenos Aires, Argentina, 1886
- Investigational Site Number : 0320012
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La Plata, Buenos Aires, Argentina, B1900BNN
- Investigational Site Number : 0320013
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320007
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320003
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320008
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Rosario, Santa Fe Province, Argentina, 2000
- Investigational Site Number : 0320011
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São Paulo, Brasilien, 04014-002
- Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760013
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Espírito Santo
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Vitória, Espírito Santo, Brasilien, 29055-450
- Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760009
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 40150-150
- Serviços Especializados em Reumatologia- Site Number : 0760020
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Federal District
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Brasília, Federal District, Brasilien, 70710-100
- Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30150-221
- Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014
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Paraná
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Curitiba, Paraná, Brasilien, 80030-110
- Centro de Estudos em Terapias Inovadoras- Site Number : 0760012
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001
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Porto Alegre, Rio Grande do Sul, Brasilien, 90480-020
- Instituto Ceos Site Number : 0760021
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Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasilien, 91010-006
- WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006
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São Paulo
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Botucatu, São Paulo, Brasilien, 18618-970
- Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760005
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Campinas, São Paulo, Brasilien, 13034-685
- Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010
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São Bernardo do Campo, São Paulo, Brasilien, 09715-090
- Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015
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Gabrovo, Bulgarien, 5300
- Investigational Site Number : 1000004
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Haskovo, Bulgarien, 6300
- Investigational Site Number : 1000007
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Rousse, Bulgarien, 7000
- Investigational Site Number : 1000018
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Rousse, Bulgarien, 7002
- Investigational Site Number : 1000010
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Sofia, Bulgarien, 1233
- Investigational Site Number : 1000001
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Sofia, Bulgarien, 1756
- Investigational Site Number : 1000009
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Sofia, Bulgarien, 1142
- Investigational Site Number : 1000016
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Stara Zagora, Bulgarien, 6000
- Investigational Site Number : 1000017
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Stara Zagora, Bulgarien, 6003
- Investigational Site Number : 1000003
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Veliko Tarnovo, Bulgarien, 5000
- Investigational Site Number : 1000013
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Vidin, Bulgarien, 3700
- Investigational Site Number : 1000006
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Alberta
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Sherwood Park, Alberta, Canada, T8H 0N2
- Investigational Site Number : 1240006
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Ontario
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Ajax, Ontario, Canada, L1S 2J5
- Investigational Site Number : 1240021
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Toronto, Ontario, Canada, M5T 3A9
- Investigational Site Number : 1240009
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Windsor, Ontario, Canada, N8X 1T3
- Investigational Site Number : 1240022
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Windsor, Ontario, Canada, N8X 5A6
- Investigational Site Number : 1240018
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Investigational Site Number : 1240004
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Trois-Rivières, Quebec, Canada, G8T 7A1
- Investigational Site Number : 1240001
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Victoriaville, Quebec, Canada, G6P 3Z8
- Investigational Site Number : 1240002
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Los Ríos Region
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Valdivia, Los Ríos Region, Chile, 5110683
- Investigational Site Number : 1520008
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Maule Region
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Talca, Maule Region, Chile, 3465584
- Investigational Site Number : 1520006
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 7500010
- Investigational Site Number : 1520007
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Santiago, Reg Metropolitana de Santiago, Chile, 7500692
- Investigational Site Number : 1520001
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Santiago, Reg Metropolitana de Santiago, Chile, 7500698
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 7750000
- Investigational Site Number : 1520002
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Valparaiso
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Quillota, Valparaiso, Chile, 2260877
- Investigational Site Number : 1520005
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Bradford, Det Forenede Kongerige, BD9 6RJ
- Investigational Site Number : 8260003
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Hounslow, Det Forenede Kongerige, TW5 9ER
- Investigational Site Number : 8260014
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Liverpool, Det Forenede Kongerige, L14 3PE
- Investigational Site Number : 8260005
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London, Det Forenede Kongerige, EC1M 6BQ
- Investigational Site Number : 8260010
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Milton Keynes, Det Forenede Kongerige, MK15 0DU
- Investigational Site Number : 8260008
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Hampshire
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Portsmouth, Hampshire, Det Forenede Kongerige, PO6 3LY
- Investigational Site Number : 8260004
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Surrey
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Chertsey, Surrey, Det Forenede Kongerige, KT16 0PZ
- Investigational Site Number : 8260002
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Tartu, Estland, 50406
- Investigational Site Number : 2330001
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Chandler Clinical Research Trials- Site Number : 8401034
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Tucson, Arizona, Forenede Stater, 85704
- Noble Clinical Research Site Number : 8401182
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Tucson, Arizona, Forenede Stater, 85712
- Tucson Clinical Research Institute- Site Number : 8401431
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California
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La Palma, California, Forenede Stater, 90623
- IMAX Clinical Trials- Site Number : 8401419
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Lancaster, California, Forenede Stater, 93534
- Antelope Valley Clinical Trials Site Number : 8401003
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Los Angeles, California, Forenede Stater, 90017
- Downtown L.A. Research Center- Site Number : 8401027
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Colorado
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Aurora, Colorado, Forenede Stater, 80014
- Allianz Research Institute CO Site Number : 8402061
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Boulder, Colorado, Forenede Stater, 80301
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
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Florida
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Boynton Beach, Florida, Forenede Stater, 33435
- Helix Biomedics- Site Number : 8402049
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Cutler Bay, Florida, Forenede Stater, 33157
- Beautiful Minds Clinical Research Center Site Number : 8401201
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DeBary, Florida, Forenede Stater, 32713
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
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Doral, Florida, Forenede Stater, 33178
- Science Connections, LLC Site Number : 8402045
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Hialeah, Florida, Forenede Stater, 33012
- Direct Helpers Research Center- Site Number : 8402065
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Lady Lake, Florida, Forenede Stater, 32159
- Premier Medical Associates Site Number : 8401388
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Loxahatchee Groves, Florida, Forenede Stater, 33470
- Advanced Pulmonary Research Institute Site Number : 8402018
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Miami, Florida, Forenede Stater, 33126
- Finlay Medical Research- Site Number : 8402007
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Miami, Florida, Forenede Stater, 33144
- Elite Clinical Research - Miami- Site Number : 8402009
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Miami, Florida, Forenede Stater, 33155
- DL Research Solutions- Site Number : 8401033
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Miami, Florida, Forenede Stater, 33155
- My Community Research Center Site Number : 8402060
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Miami, Florida, Forenede Stater, 33165
- Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
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Miami, Florida, Forenede Stater, 33173
- Research Institute of South Florida- Site Number : 8401006
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Miami, Florida, Forenede Stater, 33176
- Reed Medical Research Site Number : 8401032
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Miami, Florida, Forenede Stater, 33184
- High Quality Research Site Number : 8401406
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Miami Lakes, Florida, Forenede Stater, 33014
- Deluxe Health Center Site Number : 8401188
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Ocala, Florida, Forenede Stater, 34470
- Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
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Orlando, Florida, Forenede Stater, 32819
- Heuer M.D. Research- Site Number : 8402016
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Orlando, Florida, Forenede Stater, 32825
- Florida Institute for Clinical Research Site Number : 8401013
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Oviedo, Florida, Forenede Stater, 32765
- Oviedo Medical Research Site Number : 8402026
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Palmetto Bay, Florida, Forenede Stater, 33157
- Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
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Pembroke Pines, Florida, Forenede Stater, 33024
- Pines Care Research Center- Site Number : 8402056
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Pembroke Pines, Florida, Forenede Stater, 33025
- Tellabio International Research Services Site Number : 8401411
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Tampa, Florida, Forenede Stater, 33606
- Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
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Georgia
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Calhoun, Georgia, Forenede Stater, 30701
- Appalachian Clinical Research Site Number : 8400024
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Cordele, Georgia, Forenede Stater, 31015
- Private Practice - Dr. David Kavtaradze- Site Number : 8401029
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Dunwoody, Georgia, Forenede Stater, 30350
- Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
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East Point, Georgia, Forenede Stater, 30344
- Covenant Pulmonary Critical Care Site Number : 8401183
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Illinois
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Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Fracis Medical Center- Site Number : 8402024
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Louisiana
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Covington, Louisiana, Forenede Stater, 70433
- Benchmark Research - Covington- Site Number : 8401193
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Shreveport, Louisiana, Forenede Stater, 71105
- Care Access - Shreveport- Site Number : 8402047
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Maine
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Bangor, Maine, Forenede Stater, 04401
- Private Practice - Dr. Paul Shapero- Site Number : 8401016
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02110
- Care Access - Boston- Site Number : 8402276
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Michigan
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Lathrup Village, Michigan, Forenede Stater, 48076
- Revive Research Institute - Lathrup Village- Site Number : 8402186
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Warren, Michigan, Forenede Stater, 48088
- Pulmonary and Medicine Associates- Site Number : 8401403
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Missouri
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Hannibal, Missouri, Forenede Stater, 63401-6890
- Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
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Saint Charles, Missouri, Forenede Stater, 63301
- Midwest Chest Consultants- Site Number : 8401002
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St Louis, Missouri, Forenede Stater, 63110
- Washington University- Site Number : 8402035
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Nevada
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Henderson, Nevada, Forenede Stater, 89052
- Henderson Clinical Trials Site Number : 8401365
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New York
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Buffalo, New York, Forenede Stater, 14215
- VA Western New York Healthcare System Site Number : 8402050
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Schenectady, New York, Forenede Stater, 12308
- Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27858
- East Carolina University- Site Number : 8401022
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Huntersville, North Carolina, Forenede Stater, 28078
- Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
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Oklahoma
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Edmond, Oklahoma, Forenede Stater, 73034
- OK Clinical Research- Site Number : 8402001
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Pennsylvania
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DuBois, Pennsylvania, Forenede Stater, 15801
- Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
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Pittsburgh, Pennsylvania, Forenede Stater, 15212
- Allegheny General Hospital- Site Number : 8402058
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29204
- MedTrial- Site Number : 8402048
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Rock Hill, South Carolina, Forenede Stater, 29732
- Clinical Research of Rock Hill Site Number : 8401008
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Texas
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Beaumont, Texas, Forenede Stater, 77701
- REX Clinical Trials - Beaumont- Site Number : 8401371
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Boerne, Texas, Forenede Stater, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8402012
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Carrollton, Texas, Forenede Stater, 75007
- ClinRx Research - Carrollton- Site Number : 8401021
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Corsicana, Texas, Forenede Stater, 75110
- Corsicana Medical Research- Site Number : 8401018
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Houston, Texas, Forenede Stater, 77030
- The Methodist Hospital Research Institute Site Number : 8401194
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McKinney, Texas, Forenede Stater, 75069
- Metroplex Pulmonary and Sleep Center Site Number : 8401015
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Webster, Texas, Forenede Stater, 77598
- Clear Lake Specialties Research Center, PLLC Site Number : 8401025
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West Virginia
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Beckley, West Virginia, Forenede Stater, 25801
- Rheumatology & Pulmonary Clinic- Site Number : 8402053
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Lyon, Frankrig, 69004
- Investigational Site Number : 2500001
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Reims, Frankrig, 51092
- Investigational Site Number : 2500004
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Batumi, Georgien, 6010
- Investigational Site Number : 2680006
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Tbilisi, Georgien, 0112
- Investigational Site Number : 2680003
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Tbilisi, Georgien, 0105
- Investigational Site Number : 2680002
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Tbilisi, Georgien, 0159
- Investigational Site Number : 2680001
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Palaió Fáliro, Grækenland, 175 62
- Investigational Site Number : 3000008
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Thessaloniki, Grækenland, 570 10
- Investigational Site Number : 3000002
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Breda, Holland, 4818 CK
- Investigational Site Number : 5280001
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Calicut, Indien, 673008
- Investigational Site Number : 3560001
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Chandigarh, Indien, 160012
- Investigational Site Number : 3560006
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Hyderabad, Indien, 500 084
- Investigational Site Number : 3560005
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Jaipur, Indien, 302039
- Investigational Site Number : 3560004
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Jaipur, Indien, 302023
- Investigational Site Number : 3560009
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Kanpur, Indien, 208001
- Investigational Site Number : 3560012
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Nagpur, Indien, 441203
- Investigational Site Number : 3560003
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Nagpur, Indien, 440010
- Investigational Site Number : 3560010
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Nagpur, Indien, 440012
- Investigational Site Number : 3560011
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Nagpur, Indien, 440015
- Investigational Site Number : 3560007
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Pune, Indien, 411057
- Investigational Site Number : 3560013
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Haifa, Israel, 3436212
- Investigational Site Number : 3760008
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Jerusalem, Israel, 9103102
- Investigational Site Number : 3760003
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Jerusalem, Israel, 9112001
- Investigational Site Number : 3760002
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Kefar Sava, Israel, 4428164
- Investigational Site Number : 3760006
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Petah Tikva, Israel, 4941492
- Investigational Site Number : 3760001
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Ramat Gan, Israel, 5262100
- Investigational Site Number : 3760009
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Rehovot, Israel, 7610001
- Investigational Site Number : 3760004
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Tel Aviv, Israel, 6423906
- Investigational Site Number : 3760007
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Ferrara, Italien, 44100
- Investigational Site Number : 3800001
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Fukuoka, Japan, 819-0055
- Investigational Site Number : 3920003
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Tokyo, Japan, 140-8522
- Investigational Site Number : 3920004
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 457-8511
- Investigational Site Number : 3920008
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Fukuoka
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Kurume, Fukuoka, Japan, 830-0011
- Investigational Site Number : 3920002
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Hiroshima
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Kure, Hiroshima, Japan, 737-0811
- Investigational Site Number : 3920007
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Hyōgo
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Himeji, Hyōgo, Japan, 670-0849
- Investigational Site Number : 3920006
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Kanagawa
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Yokohama, Kanagawa, Japan, 234-0054
- Investigational Site Number : 3920009
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Mie-ken
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Matsusaka, Mie-ken, Japan, 515-0073
- Investigational Site Number : 3920001
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Tokyo
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Kiyose, Tokyo, Japan, 204-8522
- Investigational Site Number : 3920005
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Beijing, Kina, 100038
- Investigational Site Number : 1560012
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Changchun, Kina, 130021
- Investigational Site Number : 1560004
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Chengdu, Kina, 610041
- Investigational Site Number : 1560001
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Haikou, Kina, 570216
- Investigational Site Number : 1560018
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Hefei, Kina, 230032
- Investigational Site Number : 1560016
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Hohhot, Kina, 010050
- Investigational Site Number : 1560017
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Jinan, Kina, 250014
- Investigational Site Number : 1560002
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Nanchang, Kina, 330006
- Investigational Site Number : 1560014
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Pingxiang, Kina, 337055
- Investigational Site Number : 1560019
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Shanghai, Kina, 200025
- Investigational Site Number : 1560020
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Shanghai, Kina, 200433
- Investigational Site Number : 1560006
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Shenyang, Kina, 110004
- Investigational Site Number : 1560008
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Wuhan, Kina, 430014
- Investigational Site Number : 1560005
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Xiangtan, Kina, 411100
- Investigational Site Number : 1560011
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Xuzhou, Kina, 221006
- Investigational Site Number : 1560007
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Yangzhou, Kina, 225000
- Investigational Site Number : 1560015
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Kaunas, Litauen, 49449
- Investigational Site Number : 4400002
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Durango, Mexico, 34000
- Investigational Site Number : 4840007
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Lørenskog, Norge, 1478
- Investigational Site Number : 5780001
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polen, 15-044
- Investigational Site Number : 6160001
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Świętokrzyskie Voivodeship
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Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Polen, 27-400
- Investigational Site Number : 6160002
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Porto, Portugal, 3814-501
- Investigational Site Number : 6200006
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Cluj-Napoca, Rumænien, 400275
- Investigational Site Number : 6420002
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Humenné, Slovakiet, 066 01
- Investigational Site Number : 7030002
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Prešov, Slovakiet, 080 01
- Investigational Site Number : 7030004
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Spišská Nová Ves, Slovakiet, 052 01
- Investigational Site Number : 7030003
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Madrid, Spanien, 28007
- Investigational Site Number : 7240003
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Madrid, Spanien, 28040
- Investigational Site Number : 7240007
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Málaga, Spanien, 29010
- Investigational Site Number : 7240001
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Palma, Spanien, 07120
- Investigational Site Number : 7240004
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Zaragoza, Spanien, 50009
- Investigational Site Number : 7240012
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Barcelona [Barcelona]
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Barcelona, Barcelona [Barcelona], Spanien, 08017
- Investigational Site Number : 7240014
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Catalunya [Cataluña]
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Sant Boi de Llobregat, Catalunya [Cataluña], Spanien, 08830
- Investigational Site Number : 7240006
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Madrid
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- Investigational Site Number : 7240008
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Benoni, Sydafrika, 1500
- Investigational Site Number : 7100004
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Durban, Sydafrika, 4001
- Investigational Site Number : 7100001
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Durban, Sydafrika, 4001
- Investigational Site Number : 7100006
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Durban, Sydafrika, 4302
- Investigational Site Number : 7100005
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Gangwon-do
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Wŏnju, Gangwon-do, Sydkorea, 26426
- Investigational Site Number : 4100002
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Sydkorea, 05030
- Investigational Site Number : 4100001
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Kaohsiung City, Taiwan, 807
- Investigational Site Number : 1580005
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Taichung, Taiwan, 404
- Investigational Site Number : 1580006
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Taipei, Taiwan, 110
- Investigational Site Number : 1580003
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Havlíčkův Brod, Tjekkiet, 580 01
- Investigational Site Number : 2030003
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Jindřichův Hradec, Tjekkiet, 377 01
- Investigational Site Number : 2030001
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Akdeniz, Tyrkiet (Türkiye), 33070
- Investigational Site Number : 7920002
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Ankara, Tyrkiet (Türkiye), 06230
- Investigational Site Number : 7920007
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Istanbul, Tyrkiet (Türkiye), 34098
- Investigational Site Number : 7920001
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Kirikkale, Tyrkiet (Türkiye), 71100
- Investigational Site Number : 7920006
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Bendorf, Tyskland, 56170
- Investigational Site Number : 2760006
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Berlin, Tyskland, 12159
- Investigational Site Number : 2760010
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Frankfurt, Tyskland, 60596
- Investigational Site Number : 2760005
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Leipzig, Tyskland, 04299
- Investigational Site Number : 2760008
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Leipzig, Tyskland, 04347
- Investigational Site Number : 2760007
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Lübeck, Tyskland, 23552
- Investigational Site Number : 2760003
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Mainz, Tyskland, 55128
- Investigational Site Number : 2760001
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Rosenheim, Tyskland, 83022
- Investigational Site Number : 2760011
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Budapest, Ungarn, 1106
- Investigational Site Number : 3480009
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Gödöllő, Ungarn, 2100
- Investigational Site Number : 3480001
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Hajdúnánás, Ungarn, 4080
- Investigational Site Number : 3480004
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Mosonmagyaróvár, Ungarn, 9200
- Investigational Site Number : 3480002
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Püspökladány, Ungarn, 4150
- Investigational Site Number : 3480003
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.
Exclusion Criteria:
- Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
- Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
- Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
- Any situation that led to a permanent premature IMP discontinuation in parent trials
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Itepekimab Q2W
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks |
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
Andre navne:
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Eksperimentel: Itepekimab Q4W
SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP |
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous
Andre navne:
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
Tidsramme: Baseline up to Week 72
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All AEs (serious or nonserious) will be collected from the signing of the informed consent form (ICF) until the end of study visit |
Baseline up to Week 72
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Funktionelle itepekimab-koncentrationer i serum
Tidsramme: Baseline op til uge 52
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Baseline op til uge 52
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Årlig rate af svær AECOPD
Tidsramme: Baseline op til uge 52
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Baseline op til uge 52
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Tid til første moderat til svær AECOPD
Tidsramme: Baseline op til uge 52
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Baseline op til uge 52
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Tid til den første alvorlige AECOPD
Tidsramme: Baseline op til uge 52
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Baseline op til uge 52
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Forekomst af behandlings-opstående (TE) anti-narkotika-antistofreaktioner
Tidsramme: Baseline op til uge 72
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Baseline op til uge 72
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Årlig sats for moderat til svær akut forværring af KOL (AECOPD)
Tidsramme: Baseline op til uge 52
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Baseline op til uge 52
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Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1
Tidsramme: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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FEV1 is force expiratory volume in 1 second |
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores
Tidsramme: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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The St. George's Respiratory Questionnaire (SGRQ) is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. |
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score
Tidsramme: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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The European Quality of Life 5 Dimensions 5 Level Version (EQ 5D 5L) is a standardized health-related quality-of-life (HRQoL) questionnaire which consists of a descriptive system and the EuroQol visual analog scale (EQ-VAS). |
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS
Tidsramme: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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The EuroQol visual analog scale (EQ VAS) records the participant's self-rated health on a vertical VAS. |
Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
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Change from Week 0 for CASA-Q
Tidsramme: Baseline up to Week 52
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The cough and sputum assessment questionnaire (CASA-Q) was developed for use in COPD and chronic (non-obstructive) bronchitis patients. |
Baseline up to Week 52
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Clinical Sciences & Operations, Sanofi
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. januar 2024
Primær færdiggørelse (Faktiske)
10. september 2026
Studieafslutning (Faktiske)
10. september 2026
Datoer for studieregistrering
Først indsendt
5. januar 2024
Først indsendt, der opfyldte QC-kriterier
5. januar 2024
Først opslået (Faktiske)
17. januar 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- LTS18133
- U1111-1295-3333 (Registry Identifier: ICTRP)
- 2023-508085-15-00 (Registry Identifier: CTIS)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .