Parallel-Group Treatment, Double-Blind, 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects 18 to 80 Years Inclusive, Moderate to Severe Ulcerative Colitis
Status: Recruiting
Location: See all (100) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Capable of giving signed informed consent
• Male and female subjects from 18 to 80 years of age
• Diagnosis of Ulcerative Colitis
Locations
Other Locations
Argentina
Investigational Site 161704
NOT_YET_RECRUITING
Ciudad Autónoma De Buenosaires
Investigational Site 161702
NOT_YET_RECRUITING
Córdoba
Investigational Site 161701
NOT_YET_RECRUITING
Quilmes
Investigational Site 161705
NOT_YET_RECRUITING
San Miguel De Tucumán
Bulgaria
Investigational Site 160111
NOT_YET_RECRUITING
Burgas
Investigational Site 160102
NOT_YET_RECRUITING
Pleven
Investigational Site 160109
NOT_YET_RECRUITING
Rousse
Investigational Site 160101
NOT_YET_RECRUITING
Sliven
Investigational Site 160103
NOT_YET_RECRUITING
Sofia
Investigational Site 160105
NOT_YET_RECRUITING
Sofia
Investigational Site 160108
NOT_YET_RECRUITING
Sofia
Investigational Site 160107
NOT_YET_RECRUITING
Stara Zagora
Investigational Site 160106
NOT_YET_RECRUITING
Vratsa
Croatia
Investigational Site 160204
NOT_YET_RECRUITING
Bjelovar
Investigational Site 160202
NOT_YET_RECRUITING
Osijek
Investigational Site 160205
NOT_YET_RECRUITING
Rijeka
Investigational Site 160206
NOT_YET_RECRUITING
Slavonski Brod
Investigational Site 160202
NOT_YET_RECRUITING
Zagreb
Investigational Site 160207
NOT_YET_RECRUITING
Zagreb
Georgia
Investigational Site 160507
NOT_YET_RECRUITING
Batumi
Investigational Site 160501
RECRUITING
Tbilisi
Investigational Site 160502
NOT_YET_RECRUITING
Tbilisi
Investigational Site 160503
NOT_YET_RECRUITING
Tbilisi
Investigational Site 160505
NOT_YET_RECRUITING
Tbilisi
Investigational Site 160506
RECRUITING
Tbilisi
Latvia
Investigational Site 160802
RECRUITING
Liepāja
Investigational Site 160801
RECRUITING
Riga
Investigational Site 160803
RECRUITING
Riga
Poland
Investigational Site 161025
RECRUITING
Bydgoszcz
Investigational Site 161008
RECRUITING
Chojnice
Investigational Site 161013
NOT_YET_RECRUITING
Grudziądz
Investigational Site 161029
NOT_YET_RECRUITING
Kielce
Investigational Site 161028
NOT_YET_RECRUITING
Kłodzko
Investigational Site 161018
NOT_YET_RECRUITING
Knurów
Investigational Site 161035
NOT_YET_RECRUITING
Krakow
Investigational Site 1614011
RECRUITING
Ksawerów
Investigational Site 161037
NOT_YET_RECRUITING
Lodz
Investigational Site 161015
NOT_YET_RECRUITING
Lublin
Investigational Site 161033
RECRUITING
Olsztyn
Investigational Site 161021
RECRUITING
Piotrkow Trybunalski
Investigational Site 161022
NOT_YET_RECRUITING
Poznan
Investigational Site 161023
RECRUITING
Rzeszów
Investigational Site 161024
RECRUITING
Rzeszów
Investigational Site 161009
RECRUITING
Sopot
Investigational Site 161014
NOT_YET_RECRUITING
Swidnica
Investigational Site 161010
RECRUITING
Szczecin
Investigational Site 161005
NOT_YET_RECRUITING
Torun
Investigational Site 161017
RECRUITING
Tychy
Investigational Site 161007
NOT_YET_RECRUITING
Warsaw
Investigational Site 161012
RECRUITING
Warsaw
Investigational Site 161016
RECRUITING
Warsaw
Investigational Site 161041
RECRUITING
Warsaw
Investigational Site 161006
RECRUITING
Wroclaw
Investigational Site 161040
RECRUITING
Wroclaw
Investigational Site 161026
RECRUITING
Zamość
Romania
Investigational Site 161102
NOT_YET_RECRUITING
Constanța
Investigational Site 161103
NOT_YET_RECRUITING
Târgu Mureş
Investigational Site 161101
NOT_YET_RECRUITING
Timișoara
Serbia
Investigational Site 161201
NOT_YET_RECRUITING
Belgrade
Investigational Site 161203
NOT_YET_RECRUITING
Belgrade
Investigational Site 161204
NOT_YET_RECRUITING
Belgrade
Investigational Site 161206
NOT_YET_RECRUITING
Belgrade
Investigational Site 161209
NOT_YET_RECRUITING
Belgrade
Investigational Site 161205
NOT_YET_RECRUITING
Leskovac
Investigational Site 161211
NOT_YET_RECRUITING
Niš
Investigational Site 161207
NOT_YET_RECRUITING
Novi Sad
Investigational Site 161202
NOT_YET_RECRUITING
Pančevo
Investigational Site 161208
NOT_YET_RECRUITING
Zrenjanin
Slovakia
Investigational Site 161304
RECRUITING
Banská Bystrica
Investigational Site 161303
RECRUITING
Bratislava
Investigational Site 161301
RECRUITING
Košice
Investigational Site 161302
RECRUITING
Prešov
Investigational Site 161305
NOT_YET_RECRUITING
Rimavská Sobota
Investigational Site 161306
RECRUITING
Trnava
Sri Lanka
Investigational Site 162204
NOT_YET_RECRUITING
Colombo
Investigational Site 162203
NOT_YET_RECRUITING
Galle
Investigational Site 162206
NOT_YET_RECRUITING
Jaffna
Investigational Site 162205
NOT_YET_RECRUITING
Kandy
Investigational Site 162201
NOT_YET_RECRUITING
Ragama
Ukraine
Investigational Site 160411
RECRUITING
Cherkasy
Investigational Site 160401
NOT_YET_RECRUITING
Chernivtsi
Investigational Site 160412
RECRUITING
Ivano-frankivsk
Investigational Site 160404
RECRUITING
Kyiv
Investigational Site 160405
NOT_YET_RECRUITING
Kyiv
Investigational Site 160406
RECRUITING
Kyiv
Investigational Site 160413
RECRUITING
Kyiv
Investigational Site 160416
NOT_YET_RECRUITING
Kyiv
Investigational Site 160420
NOT_YET_RECRUITING
Kyiv
Investigational Site 160422
NOT_YET_RECRUITING
Kyiv
Investigational Site 160425
NOT_YET_RECRUITING
Kyiv
Investigational Site 160407
NOT_YET_RECRUITING
Lviv
Investigational Site 160409
RECRUITING
Lviv
Investigational Site 160417
RECRUITING
Lviv
Investigational Site 160408
RECRUITING
Uzhhorod
Investigational Site 160403
NOT_YET_RECRUITING
Vinnytsia
Investigational Site 160410
RECRUITING
Vinnytsia
Investigational Site 160415
NOT_YET_RECRUITING
Vinnytsia
Investigational Site 160421
RECRUITING
Vinnytsia
Investigational Site 160424
NOT_YET_RECRUITING
Vinnytsia
Investigational Site 160419
NOT_YET_RECRUITING
Zhytomyr
Contact Information
Primary
Richard Bucknall
alvotech.clinical@alvotech.com
+41 78 659 8989
Time Frame
Start Date: 2024-09-23
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 748
Treatments
Experimental: AVT16
Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
Active_comparator: Entyvio
Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
Related Therapeutic Areas
Sponsors
Leads: Alvotech Swiss AG