Clinical trial NCT06570772: Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.

Eligibility criteria: Inclusion Criteria:

* Capable of giving signed informed consent
* Male and female subjects from 18 to 80 years of age
* Diagnosis of Ulcerative Colitis

Exclusion Criteria:

* Diagnosis of Crohn's colitis
* Extensive colonic resection
* Active or latent tuberculosis

Primary outcomes:
measure: Clinical Response at week 6
timeFrame: Week 6
Secondary outcomes:
measure: Clinical Response at week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Ciudad Autónoma de BuenosAires
country: Argentina
facility: Investigational Site 161704
city: Cordoba
country: Argentina
facility: Investigational Site 161702
city: Quilmes
country: Argentina
facility: Investigational Site 161701
city: Tucumán
country: Argentina
facility: Investigational Site 161705
city: Burgas
country: Bulgaria
facility: Investigational Site 160111
city: Pleven
country: Bulgaria
facility: Investigational Site 160102
city: Ruse
country: Bulgaria
facility: Investigational Site 160109
city: Sliven
country: Bulgaria
facility: Investigational Site 160101
city: Sofia
country: Bulgaria
facility: Investigational Site 160103
city: Sofia
country: Bulgaria
facility: Investigational Site 160105
city: Sofia
country: Bulgaria
facility: Investigational Site 160108
city: Stara Zagora
country: Bulgaria
facility: Investigational Site 160107
city: Vratsa
country: Bulgaria
facility: Investigational Site 160106
city: Bjelovar
country: Croatia
facility: Investigational Site 160204
city: Osijek
country: Croatia
facility: Investigational Site 160202
city: Rijeka
country: Croatia
facility: Investigational Site 160205
city: Slavonski Brod
country: Croatia
facility: Investigational Site 160206
city: Zagreb
country: Croatia
facility: Investigational Site 160202
city: Zagreb
country: Croatia
facility: Investigational Site 160207
city: Batumi
country: Georgia
facility: Investigational Site 160507
city: Tbilisi
country: Georgia
facility: Investigational Site 160501
city: Tbilisi
country: Georgia
facility: Investigational Site 160502
city: Tbilisi
country: Georgia
facility: Investigational Site 160503
city: Tbilisi
country: Georgia
facility: Investigational Site 160505
city: Tbilisi
country: Georgia
facility: Investigational Site 160506
city: Liepāja
country: Latvia
facility: Investigational Site 160802
city: Riga
country: Latvia
facility: Investigational Site 160801
city: Riga
country: Latvia
facility: Investigational Site 160803
city: Bydgoszcz
country: Poland
facility: Investigational Site 161025
city: Chojnice
country: Poland
facility: Investigational Site 161008
city: Grudziądz
country: Poland
facility: Investigational Site 161013
city: Kielce
country: Poland
facility: Investigational Site 161029
city: Knurów
country: Poland
facility: Investigational Site 161018
city: Kraków
country: Poland
facility: Investigational Site 161035
city: Ksawerów
country: Poland
facility: Investigational Site 1614011
city: Kłodzko
country: Poland
facility: Investigational Site 161028
city: Lublin
country: Poland
facility: Investigational Site 161015
city: Olsztyn
country: Poland
facility: Investigational Site 161033
city: Piotrków Trybunalski
country: Poland
facility: Investigational Site 161021
city: Poznań
country: Poland
facility: Investigational Site 161022
city: Rzeszów
country: Poland
facility: Investigational Site 161023
city: Rzeszów
country: Poland
facility: Investigational Site 161024
city: Sopot
country: Poland
facility: Investigational Site 161009
city: Szczecin
country: Poland
facility: Investigational Site 161010
city: Toruń
country: Poland
facility: Investigational Site 161005
city: Tychy
country: Poland
facility: Investigational Site 161017
city: Warsaw
country: Poland
facility: Investigational Site 161007
city: Warsaw
country: Poland
facility: Investigational Site 161012
city: Warsaw
country: Poland
facility: Investigational Site 161016
city: Warsaw
country: Poland
facility: Investigational Site 161041
city: Wrocław
country: Poland
facility: Investigational Site 161006
city: Wrocław
country: Poland
facility: Investigational Site 161040
city: Zamość
country: Poland
facility: Investigational Site 161026
city: Łódź
country: Poland
facility: Investigational Site 161037
city: Świdnica
country: Poland
facility: Investigational Site 161014
city: Constanţa
country: Romania
facility: Investigational Site 161102
city: Timişoara
country: Romania
facility: Investigational Site 161101
city: Târgu-Mureş
country: Romania
facility: Investigational Site 161103
city: Belgrade
country: Serbia
facility: Investigational Site 161201
city: Belgrade
country: Serbia
facility: Investigational Site 161203
city: Belgrade
country: Serbia
facility: Investigational Site 161204
city: Belgrade
country: Serbia
facility: Investigational Site 161206
city: Belgrade
country: Serbia
facility: Investigational Site 161209
city: Leskovac
country: Serbia
facility: Investigational Site 161205
city: Niš
country: Serbia
facility: Investigational Site 161211
city: Novi Sad
country: Serbia
facility: Investigational Site 161207
city: Pančevo
country: Serbia
facility: Investigational Site 161202
city: Zrenjanin
country: Serbia
facility: Investigational Site 161208
city: Banská Bystrica
country: Slovakia
facility: Investigational Site 161304
city: Bratislava
country: Slovakia
facility: Investigational Site 161303
city: Košice
country: Slovakia
facility: Investigational Site 161301
city: Prešov
country: Slovakia
facility: Investigational Site 161302
city: Rimavská Sobota
country: Slovakia
facility: Investigational Site 161305
city: Trnava
country: Slovakia
facility: Investigational Site 161306
city: Colombo
country: Sri Lanka
facility: Investigational Site 162204
city: Galle
country: Sri Lanka
facility: Investigational Site 162203
city: Jaffna
country: Sri Lanka
facility: Investigational Site 162206
city: Kandy
country: Sri Lanka
facility: Investigational Site 162205
city: Ragama
country: Sri Lanka
facility: Investigational Site 162201
city: Cherkasy
country: Ukraine
facility: Investigational Site 160411
city: Chernivtsi
country: Ukraine
facility: Investigational Site 160401
city: Ivano-Frankivs'k
country: Ukraine
facility: Investigational Site 160412
city: Kyiv
country: Ukraine
facility: Investigational Site 160404
city: Kyiv
country: Ukraine
facility: Investigational Site 160405
city: Kyiv
country: Ukraine
facility: Investigational Site 160406
city: Kyiv
country: Ukraine
facility: Investigational Site 160413
city: Kyiv
country: Ukraine
facility: Investigational Site 160416
city: Kyiv
country: Ukraine
facility: Investigational Site 160420
city: Kyiv
country: Ukraine
facility: Investigational Site 160422
city: Kyiv
country: Ukraine
facility: Investigational Site 160425
city: Lviv
country: Ukraine
facility: Investigational Site 160407
city: Lviv
country: Ukraine
facility: Investigational Site 160409
city: Lviv
country: Ukraine
facility: Investigational Site 160417
city: Vinnytsia
country: Ukraine
facility: Investigational Site 160403
city: Vinnytsia
country: Ukraine
facility: Investigational Site 160410
city: Vinnytsia
country: Ukraine
facility: Investigational Site 160415
city: Vinnytsia
country: Ukraine
facility: Investigational Site 160421
city: Vinnytsia
country: Ukraine
facility: Investigational Site 160424
city: Zhytomyr
country: Ukraine
facility: Investigational Site 160419
city: Úzhgorod
country: Ukraine
facility: Investigational Site 160408
Study officials:
affiliation: Alvotech Swiss AG
name: Eveline Schurink
role: STUDY_DIRECTOR
References: