Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
NCT ID: NCT06570772
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
301 participants
INTERVENTIONAL
2024-09-23
2025-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AVT16
Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
AVT16
AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Entyvio
Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
Vedolizumab
Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Interventions
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AVT16
AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Vedolizumab
Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male and female subjects from 18 to 80 years of age
* Diagnosis of Ulcerative Colitis
Exclusion Criteria
* Extensive colonic resection
* Active or latent tuberculosis
18 Years
80 Years
ALL
No
Sponsors
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Alvotech Swiss AG
INDUSTRY
Responsible Party
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Principal Investigators
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Eveline Schurink
Role: STUDY_DIRECTOR
Alvotech Swiss AG
Locations
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Investigational Site 161704
Ciudad Autónoma de BuenosAires, , Argentina
Investigational Site 161702
Córdoba, , Argentina
Investigational Site 161701
Quilmes, , Argentina
Investigational Site 161705
San Miguel de Tucumán, , Argentina
Investigational Site 160111
Burgas, , Bulgaria
Investigational Site 160102
Pleven, , Bulgaria
Investigational Site 160109
Rousse, , 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
Osijek, , Croatia
Investigational Site 160205
Rijeka, , Croatia
Investigational Site 160206
Slavonski Brod, , Croatia
Investigational Site 160202
Zagreb, , 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
Krakow, , Poland
Investigational Site 1614011
Ksawerów, , Poland
Investigational Site 161028
Kłodzko, , Poland
Investigational Site 161037
Lodz, , Poland
Investigational Site 161015
Lublin, , Poland
Investigational Site 161033
Olsztyn, , Poland
Investigational Site 161021
Piotrkow Trybunalski, , Poland
Investigational Site 161022
Poznan, , Poland
Investigational Site 161023
Rzeszów, , Poland
Investigational Site 161024
Rzeszów, , Poland
Investigational Site 161009
Sopot, , Poland
Investigational Site 161014
Swidnica, , Poland
Investigational Site 161010
Szczecin, , Poland
Investigational Site 161005
Torun, , 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
Wroclaw, , Poland
Investigational Site 161040
Wroclaw, , Poland
Investigational Site 161026
Zamość, , Poland
Investigational Site 161102
Constanța, , Romania
Investigational Site 161103
Târgu Mureş, , Romania
Investigational Site 161101
Timișoara, , 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-Frankivsk, , 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 160408
Uzhhorod, , 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
Countries
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Other Identifiers
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AVT16-GL-C01
Identifier Type: -
Identifier Source: org_study_id