En studie för att undersöka långsiktig säkerhet och tolerabilitet av Itepekimab hos deltagare med KOL (AERIFY-4)
16 september 2026 uppdaterad av: Sanofi
En dubbelblind förlängningsstudie för att utvärdera den långsiktiga säkerheten och tolerabiliteten av Itepekimab hos patienter med kronisk obstruktiv lungsjukdom (KOL) som deltog i antingen EFC16750 eller EFC16819 kliniska 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
669
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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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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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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Lyon, Frankrike, 69004
- Investigational Site Number : 2500001
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Reims, Frankrike, 51092
- Investigational Site Number : 2500004
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Arizona
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Chandler, Arizona, Förenta staterna, 85224
- Chandler Clinical Research Trials- Site Number : 8401034
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Tucson, Arizona, Förenta staterna, 85704
- Noble Clinical Research Site Number : 8401182
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Tucson, Arizona, Förenta staterna, 85712
- Tucson Clinical Research Institute- Site Number : 8401431
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California
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La Palma, California, Förenta staterna, 90623
- IMAX Clinical Trials- Site Number : 8401419
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Lancaster, California, Förenta staterna, 93534
- Antelope Valley Clinical Trials Site Number : 8401003
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Los Angeles, California, Förenta staterna, 90017
- Downtown L.A. Research Center- Site Number : 8401027
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Colorado
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Aurora, Colorado, Förenta staterna, 80014
- Allianz Research Institute CO Site Number : 8402061
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Boulder, Colorado, Förenta staterna, 80301
- Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
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Florida
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Boynton Beach, Florida, Förenta staterna, 33435
- Helix Biomedics- Site Number : 8402049
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Cutler Bay, Florida, Förenta staterna, 33157
- Beautiful Minds Clinical Research Center Site Number : 8401201
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DeBary, Florida, Förenta staterna, 32713
- Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
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Doral, Florida, Förenta staterna, 33178
- Science Connections, LLC Site Number : 8402045
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Hialeah, Florida, Förenta staterna, 33012
- Direct Helpers Research Center- Site Number : 8402065
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Lady Lake, Florida, Förenta staterna, 32159
- Premier Medical Associates Site Number : 8401388
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Loxahatchee Groves, Florida, Förenta staterna, 33470
- Advanced Pulmonary Research Institute Site Number : 8402018
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Miami, Florida, Förenta staterna, 33126
- Finlay Medical Research- Site Number : 8402007
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Miami, Florida, Förenta staterna, 33144
- Elite Clinical Research - Miami- Site Number : 8402009
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Miami, Florida, Förenta staterna, 33155
- DL Research Solutions- Site Number : 8401033
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Miami, Florida, Förenta staterna, 33155
- My Community Research Center Site Number : 8402060
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Miami, Florida, Förenta staterna, 33165
- Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
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Miami, Florida, Förenta staterna, 33173
- Research Institute of South Florida- Site Number : 8401006
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Miami, Florida, Förenta staterna, 33176
- Reed Medical Research Site Number : 8401032
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Miami, Florida, Förenta staterna, 33184
- High Quality Research Site Number : 8401406
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Miami Lakes, Florida, Förenta staterna, 33014
- Deluxe Health Center Site Number : 8401188
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Ocala, Florida, Förenta staterna, 34470
- Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
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Orlando, Florida, Förenta staterna, 32819
- Heuer M.D. Research- Site Number : 8402016
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Orlando, Florida, Förenta staterna, 32825
- Florida Institute for Clinical Research Site Number : 8401013
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Oviedo, Florida, Förenta staterna, 32765
- Oviedo Medical Research Site Number : 8402026
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Palmetto Bay, Florida, Förenta staterna, 33157
- Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
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Pembroke Pines, Florida, Förenta staterna, 33024
- Pines Care Research Center- Site Number : 8402056
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Pembroke Pines, Florida, Förenta staterna, 33025
- Tellabio International Research Services Site Number : 8401411
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Tampa, Florida, Förenta staterna, 33606
- Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
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Georgia
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Calhoun, Georgia, Förenta staterna, 30701
- Appalachian Clinical Research Site Number : 8400024
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Cordele, Georgia, Förenta staterna, 31015
- Private Practice - Dr. David Kavtaradze- Site Number : 8401029
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Dunwoody, Georgia, Förenta staterna, 30350
- Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
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East Point, Georgia, Förenta staterna, 30344
- Covenant Pulmonary Critical Care Site Number : 8401183
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Illinois
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Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Fracis Medical Center- Site Number : 8402024
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Louisiana
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Covington, Louisiana, Förenta staterna, 70433
- Benchmark Research - Covington- Site Number : 8401193
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Shreveport, Louisiana, Förenta staterna, 71105
- Care Access - Shreveport- Site Number : 8402047
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Maine
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Bangor, Maine, Förenta staterna, 04401
- Private Practice - Dr. Paul Shapero- Site Number : 8401016
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02110
- Care Access - Boston- Site Number : 8402276
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Michigan
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Lathrup Village, Michigan, Förenta staterna, 48076
- Revive Research Institute - Lathrup Village- Site Number : 8402186
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Warren, Michigan, Förenta staterna, 48088
- Pulmonary and Medicine Associates- Site Number : 8401403
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Missouri
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Hannibal, Missouri, Förenta staterna, 63401-6890
- Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
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Saint Charles, Missouri, Förenta staterna, 63301
- Midwest Chest Consultants- Site Number : 8401002
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St Louis, Missouri, Förenta staterna, 63110
- Washington University- Site Number : 8402035
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Nevada
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Henderson, Nevada, Förenta staterna, 89052
- Henderson Clinical Trials Site Number : 8401365
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New York
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Buffalo, New York, Förenta staterna, 14215
- VA Western New York Healthcare System Site Number : 8402050
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Schenectady, New York, Förenta staterna, 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, Förenta staterna, 27858
- East Carolina University- Site Number : 8401022
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Huntersville, North Carolina, Förenta staterna, 28078
- Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
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Oklahoma
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Edmond, Oklahoma, Förenta staterna, 73034
- OK Clinical Research- Site Number : 8402001
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Pennsylvania
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DuBois, Pennsylvania, Förenta staterna, 15801
- Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
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Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny General Hospital- Site Number : 8402058
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29204
- MedTrial- Site Number : 8402048
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Rock Hill, South Carolina, Förenta staterna, 29732
- Clinical Research of Rock Hill Site Number : 8401008
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Texas
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Beaumont, Texas, Förenta staterna, 77701
- REX Clinical Trials - Beaumont- Site Number : 8401371
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Boerne, Texas, Förenta staterna, 78006
- South Texas Medical Research Institute - TTS Research- Site Number : 8402012
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Carrollton, Texas, Förenta staterna, 75007
- ClinRx Research - Carrollton- Site Number : 8401021
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Corsicana, Texas, Förenta staterna, 75110
- Corsicana Medical Research- Site Number : 8401018
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Houston, Texas, Förenta staterna, 77030
- The Methodist Hospital Research Institute Site Number : 8401194
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McKinney, Texas, Förenta staterna, 75069
- Metroplex Pulmonary and Sleep Center Site Number : 8401015
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Webster, Texas, Förenta staterna, 77598
- Clear Lake Specialties Research Center, PLLC Site Number : 8401025
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West Virginia
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Beckley, West Virginia, Förenta staterna, 25801
- Rheumatology & Pulmonary Clinic- Site Number : 8402053
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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, Grekland, 175 62
- Investigational Site Number : 3000008
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Thessaloniki, Grekland, 570 10
- Investigational Site Number : 3000002
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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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Alberta
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Sherwood Park, Alberta, Kanada, T8H 0N2
- Investigational Site Number : 1240006
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Ontario
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Ajax, Ontario, Kanada, L1S 2J5
- Investigational Site Number : 1240021
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Toronto, Ontario, Kanada, M5T 3A9
- Investigational Site Number : 1240009
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Windsor, Ontario, Kanada, N8X 1T3
- Investigational Site Number : 1240022
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Windsor, Ontario, Kanada, N8X 5A6
- Investigational Site Number : 1240018
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Quebec
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Sherbrooke, Quebec, Kanada, J1H 5N4
- Investigational Site Number : 1240004
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Trois-Rivières, Quebec, Kanada, G8T 7A1
- Investigational Site Number : 1240001
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Victoriaville, Quebec, Kanada, G6P 3Z8
- Investigational Site Number : 1240002
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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, Mexiko, 34000
- Investigational Site Number : 4840007
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Breda, Nederländerna, 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, Rumänien, 400275
- Investigational Site Number : 6420002
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Humenné, Slovakien, 066 01
- Investigational Site Number : 7030002
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Prešov, Slovakien, 080 01
- Investigational Site Number : 7030004
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Spišská Nová Ves, Slovakien, 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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Bradford, Storbritannien, BD9 6RJ
- Investigational Site Number : 8260003
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Hounslow, Storbritannien, TW5 9ER
- Investigational Site Number : 8260014
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Liverpool, Storbritannien, L14 3PE
- Investigational Site Number : 8260005
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London, Storbritannien, EC1M 6BQ
- Investigational Site Number : 8260010
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Milton Keynes, Storbritannien, MK15 0DU
- Investigational Site Number : 8260008
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Hampshire
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Portsmouth, Hampshire, Storbritannien, PO6 3LY
- Investigational Site Number : 8260004
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Surrey
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Chertsey, Surrey, Storbritannien, KT16 0PZ
- Investigational Site Number : 8260002
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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, Tjeckien, 580 01
- Investigational Site Number : 2030003
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Jindřichův Hradec, Tjeckien, 377 01
- Investigational Site Number : 2030001
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Akdeniz, Turkiet (Türkiye), 33070
- Investigational Site Number : 7920002
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Ankara, Turkiet (Türkiye), 06230
- Investigational Site Number : 7920007
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Istanbul, Turkiet (Türkiye), 34098
- Investigational Site Number : 7920001
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Kirikkale, Turkiet (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, Ungern, 1106
- Investigational Site Number : 3480009
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Gödöllő, Ungern, 2100
- Investigational Site Number : 3480001
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Hajdúnánás, Ungern, 4080
- Investigational Site Number : 3480004
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Mosonmagyaróvár, Ungern, 9200
- Investigational Site Number : 3480002
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Püspökladány, Ungern, 4150
- Investigational Site Number : 3480003
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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
Andra namn:
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Experimentell: 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
Andra namn:
Pharmaceutical form:solution for injection in pre-filled syringe Route of administration:subcutaneous |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Funktionella itepekimabkoncentrationer i serum
Tidsram: Baslinje fram till vecka 52
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Baslinje fram till vecka 52
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Årlig frekvens av svår AECOPD
Tidsram: Baslinje fram till vecka 52
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Baslinje fram till vecka 52
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Dags för första måttlig till svår AECOPD
Tidsram: Baslinje fram till vecka 52
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Baslinje fram till vecka 52
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Dags för första svåra AECOPD
Tidsram: Baslinje fram till vecka 52
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Baslinje fram till vecka 52
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Förekomst av antikroppssvar för behandlings-emgent (TE)
Tidsram: Baslinjen upp till vecka 72
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Baslinjen upp till vecka 72
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Årlig hastighet av måttlig till svår akut förvärring av KOL (AECOPD)
Tidsram: Baslinjen upp till vecka 52
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Baslinjen upp till vecka 52
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Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Studierektor: Clinical Sciences & Operations, Sanofi
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 januari 2024
Primärt slutförande (Faktisk)
10 september 2026
Avslutad studie (Faktisk)
10 september 2026
Studieregistreringsdatum
Först inskickad
5 januari 2024
Först inskickad som uppfyllde QC-kriterierna
5 januari 2024
Första postat (Faktisk)
17 januari 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LTS18133
- U1111-1295-3333 (Registeridentifierare: ICTRP)
- 2023-508085-15-00 (Registeridentifierare: CTIS)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .