En studie for å undersøke langsiktig sikkerhet og tolerabilitet av Itepekimab hos deltakere med KOLS (AERIFY-4)
16. september 2026 oppdatert av: Sanofi
En dobbeltblindet utvidelsesstudie for å evaluere langsiktig sikkerhet og tolerabilitet av Itepekimab hos pasienter med kronisk obstruktiv lungesykdom (KOLS) som deltok i enten EFC16750 eller EFC16819 kliniske studier
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
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
669
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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, Brasil, 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, Brasil, 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, Brasil, 40150-150
- Serviços Especializados em Reumatologia- Site Number : 0760020
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Federal District
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Brasília, Federal District, Brasil, 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, Brasil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014
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Paraná
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Curitiba, Paraná, Brasil, 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, Brasil, 90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001
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Porto Alegre, Rio Grande do Sul, Brasil, 90480-020
- Instituto Ceos Site Number : 0760021
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Porto Alegre, Rio Grande do Sul, Brasil, 90610-000
- Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasil, 91010-006
- WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006
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São Paulo
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Botucatu, São Paulo, Brasil, 18618-970
- Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760005
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Campinas, São Paulo, Brasil, 13034-685
- Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010
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São Bernardo do Campo, São Paulo, Brasil, 09715-090
- Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015
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Gabrovo, Bulgaria, 5300
- Investigational Site Number : 1000004
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Haskovo, Bulgaria, 6300
- Investigational Site Number : 1000007
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Rousse, Bulgaria, 7000
- Investigational Site Number : 1000018
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Rousse, Bulgaria, 7002
- Investigational Site Number : 1000010
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Sofia, Bulgaria, 1233
- Investigational Site Number : 1000001
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Sofia, Bulgaria, 1756
- Investigational Site Number : 1000009
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Sofia, Bulgaria, 1142
- Investigational Site Number : 1000016
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Stara Zagora, Bulgaria, 6000
- Investigational Site Number : 1000017
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Stara Zagora, Bulgaria, 6003
- Investigational Site Number : 1000003
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Veliko Tarnovo, Bulgaria, 5000
- Investigational Site Number : 1000013
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Vidin, Bulgaria, 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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Tartu, Estland, 50406
- Investigational Site Number : 2330001
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Arizona
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Chandler, Arizona, Forente stater, 85224
- Chandler Clinical Research Trials- Site Number : 8401034
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Tucson, Arizona, Forente stater, 85704
- Noble Clinical Research Site Number : 8401182
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Tucson, Arizona, Forente stater, 85712
- Tucson Clinical Research Institute- Site Number : 8401431
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California
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La Palma, California, Forente stater, 90623
- IMAX Clinical Trials- Site Number : 8401419
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Lancaster, California, Forente stater, 93534
- Antelope Valley Clinical Trials Site Number : 8401003
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Los Angeles, California, Forente stater, 90017
- Downtown L.A. Research Center- Site Number : 8401027
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Colorado
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Aurora, Colorado, Forente stater, 80014
- Allianz Research Institute CO Site Number : 8402061
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Boulder, Colorado, Forente stater, 80301
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
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Florida
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Boynton Beach, Florida, Forente stater, 33435
- Helix Biomedics- Site Number : 8402049
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Cutler Bay, Florida, Forente stater, 33157
- Beautiful Minds Clinical Research Center Site Number : 8401201
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DeBary, Florida, Forente stater, 32713
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
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Doral, Florida, Forente stater, 33178
- Science Connections, LLC Site Number : 8402045
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Hialeah, Florida, Forente stater, 33012
- Direct Helpers Research Center- Site Number : 8402065
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Lady Lake, Florida, Forente stater, 32159
- Premier Medical Associates Site Number : 8401388
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Loxahatchee Groves, Florida, Forente stater, 33470
- Advanced Pulmonary Research Institute Site Number : 8402018
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Miami, Florida, Forente stater, 33126
- Finlay Medical Research- Site Number : 8402007
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Miami, Florida, Forente stater, 33144
- Elite Clinical Research - Miami- Site Number : 8402009
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Miami, Florida, Forente stater, 33155
- DL Research Solutions- Site Number : 8401033
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Miami, Florida, Forente stater, 33155
- My Community Research Center Site Number : 8402060
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Miami, Florida, Forente stater, 33165
- Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
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Miami, Florida, Forente stater, 33173
- Research Institute of South Florida- Site Number : 8401006
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Miami, Florida, Forente stater, 33176
- Reed Medical Research Site Number : 8401032
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Miami, Florida, Forente stater, 33184
- High Quality Research Site Number : 8401406
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Miami Lakes, Florida, Forente stater, 33014
- Deluxe Health Center Site Number : 8401188
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Ocala, Florida, Forente stater, 34470
- Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
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Orlando, Florida, Forente stater, 32819
- Heuer M.D. Research- Site Number : 8402016
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Orlando, Florida, Forente stater, 32825
- Florida Institute for Clinical Research Site Number : 8401013
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Oviedo, Florida, Forente stater, 32765
- Oviedo Medical Research Site Number : 8402026
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Palmetto Bay, Florida, Forente stater, 33157
- Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
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Pembroke Pines, Florida, Forente stater, 33024
- Pines Care Research Center- Site Number : 8402056
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Pembroke Pines, Florida, Forente stater, 33025
- Tellabio International Research Services Site Number : 8401411
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Tampa, Florida, Forente 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, Forente stater, 30701
- Appalachian Clinical Research Site Number : 8400024
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Cordele, Georgia, Forente stater, 31015
- Private Practice - Dr. David Kavtaradze- Site Number : 8401029
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Dunwoody, Georgia, Forente stater, 30350
- Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
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East Point, Georgia, Forente stater, 30344
- Covenant Pulmonary Critical Care Site Number : 8401183
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Illinois
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Peoria, Illinois, Forente stater, 61637
- OSF Saint Fracis Medical Center- Site Number : 8402024
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Louisiana
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Covington, Louisiana, Forente stater, 70433
- Benchmark Research - Covington- Site Number : 8401193
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Shreveport, Louisiana, Forente stater, 71105
- Care Access - Shreveport- Site Number : 8402047
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Maine
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Bangor, Maine, Forente stater, 04401
- Private Practice - Dr. Paul Shapero- Site Number : 8401016
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Massachusetts
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Boston, Massachusetts, Forente stater, 02110
- Care Access - Boston- Site Number : 8402276
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Michigan
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Lathrup Village, Michigan, Forente stater, 48076
- Revive Research Institute - Lathrup Village- Site Number : 8402186
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Warren, Michigan, Forente stater, 48088
- Pulmonary and Medicine Associates- Site Number : 8401403
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Missouri
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Hannibal, Missouri, Forente stater, 63401-6890
- Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
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Saint Charles, Missouri, Forente stater, 63301
- Midwest Chest Consultants- Site Number : 8401002
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St Louis, Missouri, Forente stater, 63110
- Washington University- Site Number : 8402035
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Nevada
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Henderson, Nevada, Forente stater, 89052
- Henderson Clinical Trials Site Number : 8401365
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New York
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Buffalo, New York, Forente stater, 14215
- VA Western New York Healthcare System Site Number : 8402050
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Schenectady, New York, Forente 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, Forente stater, 27858
- East Carolina University- Site Number : 8401022
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Huntersville, North Carolina, Forente stater, 28078
- Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
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Oklahoma
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Edmond, Oklahoma, Forente stater, 73034
- OK Clinical Research- Site Number : 8402001
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Pennsylvania
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DuBois, Pennsylvania, Forente stater, 15801
- Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
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Pittsburgh, Pennsylvania, Forente stater, 15212
- Allegheny General Hospital- Site Number : 8402058
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South Carolina
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Columbia, South Carolina, Forente stater, 29204
- MedTrial- Site Number : 8402048
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Rock Hill, South Carolina, Forente stater, 29732
- Clinical Research of Rock Hill Site Number : 8401008
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Texas
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Beaumont, Texas, Forente stater, 77701
- REX Clinical Trials - Beaumont- Site Number : 8401371
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Boerne, Texas, Forente stater, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8402012
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Carrollton, Texas, Forente stater, 75007
- ClinRx Research - Carrollton- Site Number : 8401021
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Corsicana, Texas, Forente stater, 75110
- Corsicana Medical Research- Site Number : 8401018
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Houston, Texas, Forente stater, 77030
- The Methodist Hospital Research Institute Site Number : 8401194
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McKinney, Texas, Forente stater, 75069
- Metroplex Pulmonary and Sleep Center Site Number : 8401015
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Webster, Texas, Forente stater, 77598
- Clear Lake Specialties Research Center, PLLC Site Number : 8401025
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West Virginia
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Beckley, West Virginia, Forente stater, 25801
- Rheumatology & Pulmonary Clinic- Site Number : 8402053
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Lyon, Frankrike, 69004
- Investigational Site Number : 2500001
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Reims, Frankrike, 51092
- Investigational Site Number : 2500004
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Batumi, Georgia, 6010
- Investigational Site Number : 2680006
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Tbilisi, Georgia, 0112
- Investigational Site Number : 2680003
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Tbilisi, Georgia, 0105
- Investigational Site Number : 2680002
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Tbilisi, Georgia, 0159
- Investigational Site Number : 2680001
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Palaió Fáliro, Hellas, 175 62
- Investigational Site Number : 3000008
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Thessaloniki, Hellas, 570 10
- Investigational Site Number : 3000002
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Calicut, India, 673008
- Investigational Site Number : 3560001
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Chandigarh, India, 160012
- Investigational Site Number : 3560006
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Hyderabad, India, 500 084
- Investigational Site Number : 3560005
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Jaipur, India, 302039
- Investigational Site Number : 3560004
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Jaipur, India, 302023
- Investigational Site Number : 3560009
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Kanpur, India, 208001
- Investigational Site Number : 3560012
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Nagpur, India, 441203
- Investigational Site Number : 3560003
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Nagpur, India, 440010
- Investigational Site Number : 3560010
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Nagpur, India, 440012
- Investigational Site Number : 3560011
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Nagpur, India, 440015
- Investigational Site Number : 3560007
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Pune, India, 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, Italia, 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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Breda, Nederland, 4818 CK
- Investigational Site Number : 5280001
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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, Romania, 400275
- Investigational Site Number : 6420002
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Humenné, Slovakia, 066 01
- Investigational Site Number : 7030002
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Prešov, Slovakia, 080 01
- Investigational Site Number : 7030004
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Spišská Nová Ves, Slovakia, 052 01
- Investigational Site Number : 7030003
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Madrid, Spania, 28007
- Investigational Site Number : 7240003
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Madrid, Spania, 28040
- Investigational Site Number : 7240007
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Málaga, Spania, 29010
- Investigational Site Number : 7240001
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Palma, Spania, 07120
- Investigational Site Number : 7240004
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Zaragoza, Spania, 50009
- Investigational Site Number : 7240012
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Barcelona [Barcelona]
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Barcelona, Barcelona [Barcelona], Spania, 08017
- Investigational Site Number : 7240014
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Catalunya [Cataluña]
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Sant Boi de Llobregat, Catalunya [Cataluña], Spania, 08830
- Investigational Site Number : 7240006
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Madrid
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Pozuelo de Alarcón, Madrid, Spania, 28223
- Investigational Site Number : 7240008
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Bradford, Storbritannia, BD9 6RJ
- Investigational Site Number : 8260003
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Hounslow, Storbritannia, TW5 9ER
- Investigational Site Number : 8260014
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Liverpool, Storbritannia, L14 3PE
- Investigational Site Number : 8260005
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London, Storbritannia, EC1M 6BQ
- Investigational Site Number : 8260010
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Milton Keynes, Storbritannia, MK15 0DU
- Investigational Site Number : 8260008
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Hampshire
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Portsmouth, Hampshire, Storbritannia, PO6 3LY
- Investigational Site Number : 8260004
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Surrey
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Chertsey, Surrey, Storbritannia, KT16 0PZ
- Investigational Site Number : 8260002
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Gangwon-do
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Wŏnju, Gangwon-do, Sør -Korea, 26426
- Investigational Site Number : 4100002
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Seoul-teukbyeolsi
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Seoul, Seoul-teukbyeolsi, Sør -Korea, 05030
- Investigational Site Number : 4100001
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Benoni, Sør-Afrika, 1500
- Investigational Site Number : 7100004
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Durban, Sør-Afrika, 4001
- Investigational Site Number : 7100001
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Durban, Sør-Afrika, 4001
- Investigational Site Number : 7100006
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Durban, Sør-Afrika, 4302
- Investigational Site Number : 7100005
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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, Tsjekkia, 580 01
- Investigational Site Number : 2030003
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Jindřichův Hradec, Tsjekkia, 377 01
- Investigational Site Number : 2030001
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Akdeniz, Tyrkia (Türkiye), 33070
- Investigational Site Number : 7920002
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Ankara, Tyrkia (Türkiye), 06230
- Investigational Site Number : 7920007
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Istanbul, Tyrkia (Türkiye), 34098
- Investigational Site Number : 7920001
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Kirikkale, Tyrkia (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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 navn:
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Eksperimentell: 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 navn:
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Funksjonelle itepekimab-konsentrasjoner i serum
Tidsramme: Baseline frem til uke 52
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Baseline frem til uke 52
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Annualisert rate av alvorlig AECOPD
Tidsramme: Baseline frem til uke 52
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Baseline frem til uke 52
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Tid for første moderat til alvorlig AECOPD
Tidsramme: Baseline frem til uke 52
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Baseline frem til uke 52
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Tid for første alvorlige AECOPD
Tidsramme: Baseline frem til uke 52
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Baseline frem til uke 52
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Forekomst av behandlingsoppførende (TE) anti-medikamentantistoffrespons
Tidsramme: Baseline opp til uke 72
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Baseline opp til uke 72
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Årliggjort rate av moderat til alvorlig akutt forverring av KOLS (AECOPD)
Tidsramme: Baseline opp til uke 52
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Baseline opp til uke 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
|
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Clinical Sciences & Operations, Sanofi
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. januar 2024
Primær fullføring (Faktiske)
10. september 2026
Studiet fullført (Faktiske)
10. september 2026
Datoer for studieregistrering
Først innsendt
5. januar 2024
Først innsendt som oppfylte QC-kriteriene
5. januar 2024
Først lagt ut (Faktiske)
17. januar 2024
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- LTS18133
- U1111-1295-3333 (Registeridentifikator: ICTRP)
- 2023-508085-15-00 (Registeridentifikator: CTIS)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .