Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
- Registration Number
- NCT06570772
- Lead Sponsor
- Alvotech Swiss AG
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 748
- Capable of giving signed informed consent
- Male and female subjects from 18 to 80 years of age
- Diagnosis of Ulcerative Colitis
- Diagnosis of Crohn's colitis
- Extensive colonic resection
- Active or latent tuberculosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Entyvio Vedolizumab Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16 AVT16 AVT16 Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
- Primary Outcome Measures
Name Time Method Clinical Response at week 6 Week 6 Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
- Secondary Outcome Measures
Name Time Method Clinical Response at week 52 Week 52 Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
Trial Locations
- Locations (99)
Investigational Site 161704
🇦🇷Ciudad Autónoma de BuenosAires, Argentina
Investigational Site 161702
🇦🇷Cordoba, Argentina
Investigational Site 161701
🇦🇷Quilmes, Argentina
Investigational Site 161705
🇦🇷Tucumán, Argentina
Investigational Site 160111
🇧🇬Burgas, Bulgaria
Investigational Site 160102
🇧🇬Pleven, Bulgaria
Investigational Site 160109
🇧🇬Ruse, Bulgaria
Investigational Site 160101
🇧🇬Sliven, Bulgaria
Investigational Site 160103
🇧🇬Sofia, Bulgaria
Investigational Site 160105
🇧🇬Sofia, Bulgaria
Investigational Site 160108
🇧🇬Sofia, Bulgaria
Investigational Site 160107
🇧🇬Stara Zagora, Bulgaria
Investigational Site 160106
🇧🇬Vratsa, Bulgaria
Investigational Site 160204
🇭🇷Bjelovar, Croatia
Investigational Site 160202
🇭🇷Zagreb, Croatia
Investigational Site 160205
🇭🇷Rijeka, Croatia
Investigational Site 160206
🇭🇷Slavonski Brod, Croatia
Investigational Site 160207
🇭🇷Zagreb, Croatia
Investigational Site 160507
🇬🇪Batumi, Georgia
Investigational Site 160501
🇬🇪Tbilisi, Georgia
Investigational Site 160502
🇬🇪Tbilisi, Georgia
Investigational Site 160503
🇬🇪Tbilisi, Georgia
Investigational Site 160505
🇬🇪Tbilisi, Georgia
Investigational Site 160506
🇬🇪Tbilisi, Georgia
Investigational Site 160802
🇱🇻Liepāja, Latvia
Investigational Site 160801
🇱🇻Riga, Latvia
Investigational Site 160803
🇱🇻Riga, Latvia
Investigational Site 161025
🇵🇱Bydgoszcz, Poland
Investigational Site 161008
🇵🇱Chojnice, Poland
Investigational Site 161013
🇵🇱Grudziądz, Poland
Investigational Site 161029
🇵🇱Kielce, Poland
Investigational Site 161018
🇵🇱Knurów, Poland
Investigational Site 161035
🇵🇱Kraków, Poland
Investigational Site 1614011
🇵🇱Ksawerów, Poland
Investigational Site 161028
🇵🇱Kłodzko, Poland
Investigational Site 161015
🇵🇱Lublin, Poland
Investigational Site 161033
🇵🇱Olsztyn, Poland
Investigational Site 161021
🇵🇱Piotrków Trybunalski, Poland
Investigational Site 161022
🇵🇱Poznań, Poland
Investigational Site 161023
🇵🇱Rzeszów, Poland
Investigational Site 161024
🇵🇱Rzeszów, Poland
Investigational Site 161009
🇵🇱Sopot, Poland
Investigational Site 161010
🇵🇱Szczecin, Poland
Investigational Site 161005
🇵🇱Toruń, Poland
Investigational Site 161017
🇵🇱Tychy, Poland
Investigational Site 161007
🇵🇱Warsaw, Poland
Investigational Site 161012
🇵🇱Warsaw, Poland
Investigational Site 161016
🇵🇱Warsaw, Poland
Investigational Site 161041
🇵🇱Warsaw, Poland
Investigational Site 161006
🇵🇱Wrocław, Poland
Investigational Site 161040
🇵🇱Wrocław, Poland
Investigational Site 161026
🇵🇱Zamość, Poland
Investigational Site 161037
🇵🇱Łódź, Poland
Investigational Site 161014
🇵🇱Świdnica, Poland
Investigational Site 161102
🇷🇴Constanţa, Romania
Investigational Site 161101
🇷🇴Timişoara, Romania
Investigational Site 161103
🇷🇴Târgu-Mureş, Romania
Investigational Site 161201
🇷🇸Belgrade, Serbia
Investigational Site 161203
🇷🇸Belgrade, Serbia
Investigational Site 161204
🇷🇸Belgrade, Serbia
Investigational Site 161206
🇷🇸Belgrade, Serbia
Investigational Site 161209
🇷🇸Belgrade, Serbia
Investigational Site 161205
🇷🇸Leskovac, Serbia
Investigational Site 161211
🇷🇸Niš, Serbia
Investigational Site 161207
🇷🇸Novi Sad, Serbia
Investigational Site 161202
🇷🇸Pančevo, Serbia
Investigational Site 161208
🇷🇸Zrenjanin, Serbia
Investigational Site 161304
🇸🇰Banská Bystrica, Slovakia
Investigational Site 161303
🇸🇰Bratislava, Slovakia
Investigational Site 161301
🇸🇰Košice, Slovakia
Investigational Site 161302
🇸🇰Prešov, Slovakia
Investigational Site 161305
🇸🇰Rimavská Sobota, Slovakia
Investigational Site 161306
🇸🇰Trnava, Slovakia
Investigational Site 162204
🇱🇰Colombo, Sri Lanka
Investigational Site 162203
🇱🇰Galle, Sri Lanka
Investigational Site 162206
🇱🇰Jaffna, Sri Lanka
Investigational Site 162205
🇱🇰Kandy, Sri Lanka
Investigational Site 162201
🇱🇰Ragama, Sri Lanka
Investigational Site 160411
🇺🇦Cherkasy, Ukraine
Investigational Site 160401
🇺🇦Chernivtsi, Ukraine
Investigational Site 160412
🇺🇦Ivano-Frankivs'k, Ukraine
Investigational Site 160404
🇺🇦Kyiv, Ukraine
Investigational Site 160405
🇺🇦Kyiv, Ukraine
Investigational Site 160406
🇺🇦Kyiv, Ukraine
Investigational Site 160413
🇺🇦Kyiv, Ukraine
Investigational Site 160416
🇺🇦Kyiv, Ukraine
Investigational Site 160420
🇺🇦Kyiv, Ukraine
Investigational Site 160422
🇺🇦Kyiv, Ukraine
Investigational Site 160425
🇺🇦Kyiv, Ukraine
Investigational Site 160407
🇺🇦Lviv, Ukraine
Investigational Site 160409
🇺🇦Lviv, Ukraine
Investigational Site 160417
🇺🇦Lviv, Ukraine
Investigational Site 160403
🇺🇦Vinnytsia, Ukraine
Investigational Site 160410
🇺🇦Vinnytsia, Ukraine
Investigational Site 160415
🇺🇦Vinnytsia, Ukraine
Investigational Site 160421
🇺🇦Vinnytsia, Ukraine
Investigational Site 160424
🇺🇦Vinnytsia, Ukraine
Investigational Site 160419
🇺🇦Zhytomyr, Ukraine
Investigational Site 160408
🇺🇦Úzhgorod, Ukraine