Undersøgelse til evaluering af sikkerhed, effektivitet og immunogenicitet af acne-mRNA-vaccine hos voksne med moderat til svær acne
19. august 2026 opdateret af: Sanofi Pasteur, a Sanofi Company
En fase I/II, randomiseret, placebokontrolleret, multi-arm, dosisfindende undersøgelse til evaluering af sikkerheden, effektiviteten og immunogeniciteten af en acne-mRNA-vaccinekandidat hos voksne med moderat til svær acne i alderen 18 til 45 år
Formålet med forsøget er at evaluere sikkerheden, effektiviteten og immunogeniciteten af en eller to intramuskulære injektioner af Acne mRNA-vaccinekandidaten ved tre dosisniveauer hos voksne deltagere i alderen 18 til 45 år med moderat til svær acne i USA.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Acne vulgaris (akne) er en meget udbredt inflammatorisk hudsygdom, især hos unge og unge voksne. Acne anslås at påvirke 231 millioner mennesker verden over, og er derfor en af de mest udbredte sygdomme globalt. Acne er også en af de vigtigste årsager til år levet med handicap og ikke-dødelig sygdomsbyrde. På trods af at det er en af de mest udbredte sygdomme på verdensplan, er grundpillerne i acnebehandling stort set uændret i løbet af de sidste 30 år. Til dato er der stadig ingen effektiv behandling, der kan forebygge og helbrede denne sygdom.
Formålet med dette første-i-menneske (FIH), fase I/II-forsøg er at evaluere sikkerheden, effektiviteten og immunogeniciteten af Acne mRNA-vaccinekandidaten ved tre forskellige dosisniveauer hos voksne i alderen 18 til 45 år med moderat til svær acne. . Studiet er designet til at vurdere sikkerhedsprofilen og effektiviteten (også langsigtet) af vaccinekandidaten, vælge dosis til de yderligere kliniske udviklingstrin og beskrive vaccinens immunogenicitetsprofil.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
800
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial Transparency email recommended (Toll free for US & Canada)
- Telefonnummer: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Studiesteder
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Australian Capital Territory
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Phillip, Australian Capital Territory, Australien, 2606
- Rekruttering
- Investigational Site Number : 0360001
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New South Wales
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Kotara, New South Wales, Australien, 2289
- Rekruttering
- Investigational Site Number : 0360008
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Sydney, New South Wales, Australien, 2010
- Rekruttering
- Investigational Site Number : 0360003
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Waitara, New South Wales, Australien, 2077
- Rekruttering
- Investigational Site Number : 0360006
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Queensland
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Woolloongabba, Queensland, Australien, 4102
- Rekruttering
- Investigational Site Number : 0360005
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Victoria
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Carlton, Victoria, Australien, 3053
- Rekruttering
- Investigational Site Number : 0360007
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Melbourne, Victoria, Australien, 3004
- Rekruttering
- Investigational Site Number : 0360002
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Melbourne, Victoria, Australien, 3124
- Rekruttering
- Investigational Site Number : 0360009
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Alberta
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Edmonton, Alberta, Canada, T5J 3S9
- Rekruttering
- Investigational Site Number : 1240006
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- Rekruttering
- Investigational Site Number : 1240001
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Toronto, Ontario, Canada, M4E 1R7
- Rekruttering
- Investigational Site Number : 1240004
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Quebec
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Montreal, Quebec, Canada, H1Y 3L1
- Rekruttering
- Investigational Site Number : 1240009
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Québec, Quebec, Canada, G1W 4R4
- Rekruttering
- Investigational Site Number : 1240007
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Sherbrooke, Quebec, Canada, J1G 1X9
- Rekruttering
- Investigational Site Number : 1240008
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85260
- Rekruttering
- Center for Dermatology and Plastic Surgery- Site Number : 8400111
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California
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Cerritos, California, Forenede Stater, 90703
- Rekruttering
- Private Practice - Dr. Francisco Badar- Site Number : 8400067
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Encino, California, Forenede Stater, 91436
- Rekruttering
- Encino Research Center- Site Number : 8400033
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La Mesa, California, Forenede Stater, 91942
- Rekruttering
- Paradigm Clinical Research Centers- Site Number : 8400064
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Lafayette, California, Forenede Stater, 94549
- Rekruttering
- Sunwise Clinical Research- Site Number : 8400108
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Lancaster, California, Forenede Stater, 93534
- Rekruttering
- Chemidox Clinical Trials- Site Number : 8400075
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Los Angeles, California, Forenede Stater, 90027
- Rekruttering
- Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400058
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Los Angeles, California, Forenede Stater, 90057
- Rekruttering
- LA Universal Research Center- Site Number : 8400059
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Los Angeles, California, Forenede Stater, 91307
- Rekruttering
- Alliance Clinical - West Hills- Site Number : 8400131
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North Hollywood, California, Forenede Stater, 91606
- Rekruttering
- Carbon Health - North Hollywood - NoHo West- Site Number : 8400076
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Northridge, California, Forenede Stater, 91325
- Rekruttering
- Northridge Clinical Trials - Northridge- Site Number : 8400053
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Oceanside, California, Forenede Stater, 92056
- Rekruttering
- Profound Research - Dermatologist Medical Group of North County- Site Number : 8400099
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Oxnard, California, Forenede Stater, 93030
- Rekruttering
- Cura Clinical Research - Oxnard- Site Number : 8400062
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Palmdale, California, Forenede Stater, 93551
- Rekruttering
- Amicis Research Center, LLC- Site Number : 8400110
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Pomona, California, Forenede Stater, 91767
- Rekruttering
- Empire Clinical Research - Pomona- Site Number : 8400055
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Rolling Hills Estates, California, Forenede Stater, 90274
- Rekruttering
- Peninsula Research Associates- Site Number : 8400102
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San Diego, California, Forenede Stater, 92123
- Rekruttering
- California Research Foundation- Site Number : 8400095
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San Diego, California, Forenede Stater, 92103
- Rekruttering
- Artemis Institute for Clinical Research - San Diego - Washington Street- Site Number : 8400103
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Santa Rosa, California, Forenede Stater, 95405
- Rekruttering
- NorthBay Clinical Research- Site Number : 8400066
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Florida
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Boynton Beach, Florida, Forenede Stater, 33436
- Rekruttering
- Encore Medical Research of Boynton Beach- Site Number : 8400116
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Coral Gables, Florida, Forenede Stater, 33134
- Rekruttering
- Driven Research- Site Number : 8400135
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Coral Gables, Florida, Forenede Stater, 33134
- Rekruttering
- Universal Medical Research - Coral Gables- Site Number : 8400081
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Coral Gables, Florida, Forenede Stater, 33134
- Rekruttering
- HealthMed Clinical Center- Site Number : 8400071
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Cutler Bay, Florida, Forenede Stater, 33157
- Rekruttering
- Genomics Medical Research- Site Number : 8400120
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Hialeah, Florida, Forenede Stater, 33012
- Rekruttering
- Direct Helpers Research Center- Site Number : 8400118
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Hollywood, Florida, Forenede Stater, 33021
- Rekruttering
- Zenith Clinical Research- Site Number : 8400127
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Hollywood, Florida, Forenede Stater, 33024
- Rekruttering
- Encore Medical Research - Hollywood- Site Number : 8400122
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Homestead, Florida, Forenede Stater, 33030
- Rekruttering
- Universal Medical and Research Center- Site Number : 8400079
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Jacksonville, Florida, Forenede Stater, 32216
- Rekruttering
- Encore Research Group-Jacksonville Center for Clinical Research- Site Number : 8400006
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Lady Lake, Florida, Forenede Stater, 32159
- Rekruttering
- K2 Medical Research - The Villages - Northeast 138th Lane- Site Number : 8400063
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Miami, Florida, Forenede Stater, 33126
- Rekruttering
- Dr. Manuel J Hernandez Clinical Research and Associates, Inc.- Site Number : 8400106
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Miami, Florida, Forenede Stater, 33136
- Rekruttering
- SouthCoast Research Center- Site Number : 8400114
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Miami, Florida, Forenede Stater, 33174
- Rekruttering
- Advanced Medical Research Institute - Miami- Site Number : 8400100
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- WellQuest Clinical- Site Number : 8400082
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Miami, Florida, Forenede Stater, 33176
- Rekruttering
- Health and Life Research Institute- Site Number : 8400070
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Ocala, Florida, Forenede Stater, 34470
- Rekruttering
- Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8400021
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Plantation, Florida, Forenede Stater, 33317
- Rekruttering
- Leading Edge Dermatology- Site Number : 8400077
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Pompano Beach, Florida, Forenede Stater, 33060
- Rekruttering
- Nuline Clinical Trial Center- Site Number : 8400060
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Tamarac, Florida, Forenede Stater, 33321
- Rekruttering
- D&H Tamarac Research Center- Site Number : 8400121
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Tampa, Florida, Forenede Stater, 33609
- Rekruttering
- TrueBlue Clinical Research- Site Number : 8400016
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Optimum Clinical Trial Group- Site Number : 8400125
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Tampa, Florida, Forenede Stater, 33613
- Rekruttering
- CenExel FCR Tampa- Site Number : 8400130
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Georgia
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Decatur, Georgia, Forenede Stater, 30030
- Rekruttering
- Accel Research Sites - NeuroStudies- Site Number : 8400134
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Illinois
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Chicago, Illinois, Forenede Stater, 60614
- Rekruttering
- MetroMed Clinical Trials- Site Number : 8400054
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Oak Brook, Illinois, Forenede Stater, 60523
- Rekruttering
- AMR Chicago- Site Number : 8400019
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Skokie, Illinois, Forenede Stater, 60077
- Rekruttering
- NorthShore University Health System - Endeavor Health Medical Group - Skokie - Woods Drive- Site Number : 8400031
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46256
- Rekruttering
- Dawes Fretzin Clinical Research- Site Number : 8400022
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- Rekruttering
- Accellacare - McFarland Clinic- Site Number : 8400045
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West Des Moines, Iowa, Forenede Stater, 50266
- Rekruttering
- The Iowa Clinic West Des Moines Campus- Site Number : 8400084
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Kentucky
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Bowling Green, Kentucky, Forenede Stater, 42104
- Rekruttering
- Equity Medical - Bowling Green- Site Number : 8400093
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- Rekruttering
- Louisiana Dermatology Associates- Site Number : 8400043
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Metairie, Louisiana, Forenede Stater, 70006
- Rekruttering
- Clinical Trials Management - Metairie- Site Number : 8400072
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New Orleans, Louisiana, Forenede Stater, 70115
- Rekruttering
- DelRicht Research - New Orleans 308- Site Number : 8400013
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Rekruttering
- Private Practice - Dr. Lawrence J. Green- Site Number : 8400024
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Massachusetts
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Brighton, Massachusetts, Forenede Stater, 02135
- Rekruttering
- MetroBoston Clinical Partners - Brighton- Site Number : 8400008
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Marlborough, Massachusetts, Forenede Stater, 01752
- Rekruttering
- Kuchnir Dermatology & Dermatologic Surgery- Site Number : 8400096
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Michigan
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Allen Park, Michigan, Forenede Stater, 48101
- Rekruttering
- Michigan Institute of Research- Site Number : 8400092
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Dearborn Heights, Michigan, Forenede Stater, 48127
- Rekruttering
- Vida Clinical Studies - Dearborn Heights- Site Number : 8400074
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Rekruttering
- Clinical Research Institute - Minneapolis- Site Number : 8400080
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Missouri
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Saint Joseph, Missouri, Forenede Stater, 64506
- Rekruttering
- MediSearch Clinical Trials- Site Number : 8400035
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Montana
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Missoula, Montana, Forenede Stater, 59804
- Rekruttering
- Boeson Research - Missoula- Site Number : 8400069
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89030
- Rekruttering
- Las Vegas Clinical Trials- Site Number : 8400056
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North Carolina
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Wilmington, North Carolina, Forenede Stater, 28403
- Rekruttering
- Trial Management Associates - Wilmington - Floral Parkway- Site Number : 8400104
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73112
- Rekruttering
- Lynn Institute of Oklahoma City- Site Number : 8400004
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Pennsylvania
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Camp Hill, Pennsylvania, Forenede Stater, 17011
- Rekruttering
- Best Skin Research - Camp Hill- Site Number : 8400017
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South Carolina
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Mt. Pleasant, South Carolina, Forenede Stater, 29464
- Rekruttering
- Delricht Research - Mt Pleasant Dermatology- Site Number : 8400047
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Tennessee
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Smyrna, Tennessee, Forenede Stater, 37167
- Rekruttering
- DelRicht Research - Thompson's Station- Site Number : 8400041
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Texas
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Baytown, Texas, Forenede Stater, 77521
- Rekruttering
- Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400115
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Carrollton, Texas, Forenede Stater, 75010
- Rekruttering
- DFW Clinical Trials- Site Number : 8400057
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Dallas, Texas, Forenede Stater, 75231
- Rekruttering
- Modern Research Associates- Site Number : 8400094
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Houston, Texas, Forenede Stater, 77004
- Rekruttering
- Center for Clinical Studies - Houston - Binz Street- Site Number : 8400002
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Katy, Texas, Forenede Stater, 77450
- Rekruttering
- Lone Star Clinical Research - Katy- Site Number : 8400049
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Prosper, Texas, Forenede Stater, 75078
- Rekruttering
- DelRicht Research - Lockhart Matter Dermatology & Aesthetic Center- Site Number : 8400046
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Utah
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Bountiful, Utah, Forenede Stater, 84010
- Rekruttering
- Cope Family Medicine - Ogden Clinic- Site Number : 8400112
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Layton, Utah, Forenede Stater, 84041
- Rekruttering
- Alpine Research Association- Site Number : 8400050
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Salt Lake City, Utah, Forenede Stater, 84107
- Rekruttering
- CenExel JRB - Salth Lake City- Site Number : 8400128
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Springville, Utah, Forenede Stater, 84663
- Rekruttering
- Springville Dermatology - Springville- Site Number : 8400113
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Virginia
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Lynchburg, Virginia, Forenede Stater, 24501
- Rekruttering
- The Education & Research Foundation- Site Number : 8400036
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Washington
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Seattle, Washington, Forenede Stater, 98104
- Rekruttering
- Seattle Clinical Research Center- Site Number : 8400038
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San Juan, Puerto Rico, 00909
- Rekruttering
- Investigational Site Number : 6300002
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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
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Deltagere, der er åbenlyst raske som bestemt af medicinsk evaluering, herunder sygehistorie, fysisk undersøgelse og laboratorietests som bedømt af investigator
- Klinisk diagnose af moderat eller svær ansigtsacne vulgaris med Investigator's Global Assessment (IGA)-score på Moderat eller Svær (grad 3 eller grad 4 på 5-grads IGA-skalaen) og ≥ 25 ikke-inflammatoriske læsioner (dvs. åbne og lukkede komedoner) og ≥ 20 inflammatoriske læsioner (dvs. papler og pustler) og ≤ 2 nodulocystiske læsioner (dvs. knuder og cyster)
Ekskluderingskriterier:
Deltagerne udelukkes fra undersøgelsen, hvis et af følgende kriterier gælder:
- Kendt eller mistænkt medfødt eller erhvervet immundefekt; eller modtagelse af immunsuppressiv terapi, såsom anti-cancer kemoterapi eller strålebehandling, inden for 6 måneder før den første undersøgelsesinterventionsadministration; eller langvarig systemisk kortikosteroidbehandling (prednison eller tilsvarende i mere end 2 på hinanden følgende uger inden for de seneste 3 måneder)
- Kendt systemisk overfølsomhed over for nogen af undersøgelsens interventionskomponenter (f.eks. polyethylenglycol [PEG], polysorbat); historie med en livstruende reaktion på de undersøgelsesinterventioner, der blev brugt i undersøgelsen, eller på et produkt, der indeholder et eller flere af de samme stoffer; enhver allergisk reaktion (f.eks. anafylaksi) efter administration af mRNA coronavirus disease 2019 (COVID-19) vaccine
- Aktiv nodulocystisk acne, acne conglobat, acne fulminans, sekundær acne (f.eks. chloracne, lægemiddelinduceret acne) eller andre former for acne (fx acne mechanica)
- Brug af enhver acne-påvirkende behandling uden en passende udvaskningsperiode
- Modtagelse af enhver vaccine (bortset fra undersøgelsesvaccinen) i de 4 uger forud for enhver undersøgelsesinterventionsadministration eller planlagt modtagelse af enhver vaccine (andre end undersøgelsesvaccinen) i de 4 uger efter enhver undersøgelsesinterventionsadministration
- Tidligere vaccination mod C. acnes med en forsøgsvaccine
- Modtagelse af immunglobuliner, blod eller blodafledte produkter inden for de seneste 3 måneder
- Selvrapporteret eller dokumenteret seropositivitet for humant immundefektvirus (HIV), hepatitis B-virus eller hepatitis C-virus.
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: Sekventiel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sentinel -kohort A - Eksperimentel
To administrationer af acne mRNA -vaccinen injiceres i tre stigende doser
|
Farmaceutisk form: flydende suspension til injektionsadministration: intramuskulær
|
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Placebo komparator: Sentinel -kohort A - placebo
To administrationer af placebo injiceres
|
Farmaceutisk form: Liquidopløsning til injektionsadministration: Intramuskulær
|
|
Eksperimentel: Sentinel -kohort B - Eksperimentel
Tre administrationer af acne mRNA -vaccinen injiceres i to stigende doser
|
Farmaceutisk form: flydende suspension til injektionsadministration: intramuskulær
|
|
Placebo komparator: Sentinel -kohort B - placebo
Tre administrationer af placebo injiceres
|
Farmaceutisk form: Liquidopløsning til injektionsadministration: Intramuskulær
|
|
Eksperimentel: Main Cohort A - Experimental
Two administrations of the Acne mRNA vaccine will be injected in three increasing doses
|
Farmaceutisk form: flydende suspension til injektionsadministration: intramuskulær
|
|
Placebo komparator: Main Cohort A - Placebo
Two administrations of placebo will be injected
|
Farmaceutisk form: Liquidopløsning til injektionsadministration: Intramuskulær
|
|
Eksperimentel: Main Cohort B - Experimental
Three administrations of the Acne mRNA vaccine will be injected in two increasing doses
|
Farmaceutisk form: flydende suspension til injektionsadministration: intramuskulær
|
|
Placebo komparator: Main Cohort B - Placebo
Three administrations of placebo will be injected
|
Farmaceutisk form: Liquidopløsning til injektionsadministration: Intramuskulær
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited systemic AEs
Tidsramme: 30 minutes after each administration
|
Presence of unsolicited systemic adverse events (AEs) reported
|
30 minutes after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Tidsramme: Up to 7 days after each administration
|
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])
|
Up to 7 days after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with unsolicited AEs
Tidsramme: Up to 28 days after each administration
|
Up to 28 days after each administration
|
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with MAAEs
Tidsramme: Up to 6 months after each administration
|
Presence of medically attended adverse events (MAAEs)
|
Up to 6 months after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with SAEs
Tidsramme: Up to 6 months after each administration
|
Presence of all serious adverse events (SAEs)
|
Up to 6 months after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with AESIs
Tidsramme: Up to 6 months after each administration
|
Presence of AEs of special interest (AESIs)
|
Up to 6 months after each administration
|
|
Core Study - Sentinel Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Tidsramme: Through 7 days after administration (Day 8)
|
Through 7 days after administration (Day 8)
|
|
|
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Tidsramme: At 2 months post last administration
|
At 2 months post last administration
|
|
|
Core Study - Main Cohort A: Percentage change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Tidsramme: At 2 months post last administration
|
At 2 months post last administration
|
|
|
Core Study - Main Cohort B: Percentage change from baseline (Day 1) in the total number of acne lesions on face at
Tidsramme: At 2 months post last administration
|
At 2 months post last administration
|
|
|
Long-Term Extension - Sentinel Cohorts A, B and Main Cohort: Number of participants with SAEs and AESIs
Tidsramme: Up to 38 or 40 months after first administration
|
Presence of all serious adverse events (SAEs) and adverse events of special interest (AESIs)
|
Up to 38 or 40 months after first administration
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Core Study - Sentinel Cohorts A, B and Main Cohorts A and B: Assessment of accine-antigen-specific serum antibody titers
Tidsramme: From baseline (Day 1) to 6 months post last administration
|
From baseline (Day 1) to 6 months post last administration
|
|
|
Core Study - Main Cohort B: Absolute change from baseline (Day 1) in the total number of inflammatory acne lesions on face
Tidsramme: At 1 month post first administration until 9 months post last administration
|
At 1 month post first administration until 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Percentage change from baseline (Day 1) in the number of inflammatory acne lesions on face
Tidsramme: At 1 month post first administration until 6 or 9 months post last administration
|
At 1 month post first administration until 6 or 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Absolute change from baseline (Day 1) in the number of non-inflammatory acne lesions on face
Tidsramme: At 1 month post first administration until 6 or 9 months post last administration
|
At 1 month post first administration until 6 or 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Absolute change from baseline in IGA score
Tidsramme: At 1 month post first administration until 6 or 9 months post last administration
|
At 1 month post first administration until 6 or 9 months post last administration
|
|
|
Core Study - Main Cohorts A and B: Number of participants with unsolicited systemic AEs
Tidsramme: 30 minutes after each administration
|
Presence of unsolicited systemic adverse events (AEs) reported
|
30 minutes after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with solicited injection site and systemic reactions
Tidsramme: Up to 7 days after each administration
|
Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant diary [PDi] and in the case report form [CRF])
|
Up to 7 days after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with unsolicited AEs
Tidsramme: Up to 28 days after each administration
|
Up to 28 days after each administration
|
|
|
Core Study - Main Cohorts A and B: Number of participants with MAAEs
Tidsramme: Up to 6 or 9 months after each administration
|
Presence of medically attended adverse events (MAAEs)
|
Up to 6 or 9 months after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with SAEs
Tidsramme: Up to 6 or 9 months after each administration
|
Presence of all serious adverse events (SAEs)
|
Up to 6 or 9 months after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with AESIs
Tidsramme: Up to 6 or 9 months after each administration
|
Presence of AEs of special interest (AESIs)
|
Up to 6 or 9 months after each administration
|
|
Core Study - Main Cohorts A and B: Number of participants with out-of-range biological test results (including shift from baseline values)
Tidsramme: Up to 7 days after each administration
|
Up to 7 days after each administration
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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)
5. april 2024
Primær færdiggørelse (Anslået)
30. november 2028
Studieafslutning (Anslået)
30. november 2028
Datoer for studieregistrering
Først indsendt
12. marts 2024
Først indsendt, der opfyldte QC-kriterier
12. marts 2024
Først opslået (Faktiske)
18. marts 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VBE00001
- 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- U1111-1295-3154 (Registry Identifier: ICTRP)
- 2025-521740-38 (Registry Identifier: CTIS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Kvalificerede forskere kan anmode om adgang til data på patientniveau og relaterede undersøgelsesdokumenter, herunder den kliniske undersøgelsesrapport, undersøgelsesprotokol med eventuelle ændringer, blank case-rapportformular, statistisk analyseplan og datasætspecifikationer.
Data på patientniveau vil blive anonymiseret, og undersøgelsesdokumenter vil blive redigeret for at beskytte forsøgsdeltagernes privatliv.
Yderligere detaljer om Sanofis kriterier for datadeling, kvalificerede undersøgelser og proces for at anmode om adgang kan findes på: 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 .