Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

December 19, 2025 updated by: Alvotech Swiss AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autónoma de BuenosAires, Argentina
        • Investigational Site 161704
      • Córdoba, Argentina
        • Investigational Site 161702
      • Quilmes, Argentina
        • Investigational Site 161701
      • San Miguel de Tucumán, Argentina
        • Investigational Site 161705
  • Bulgaria
      • Burgas, Bulgaria
        • Investigational Site 160111
      • Pleven, Bulgaria
        • Investigational Site 160102
      • Rousse, Bulgaria
        • Investigational Site 160109
      • Sliven, Bulgaria
        • Investigational Site 160101
      • Sofia, Bulgaria
        • Investigational Site 160103
      • Sofia, Bulgaria
        • Investigational Site 160105
      • Sofia, Bulgaria
        • Investigational Site 160108
      • Stara Zagora, Bulgaria
        • Investigational Site 160107
      • Vratsa, Bulgaria
        • Investigational Site 160106
  • Croatia
      • Bjelovar, Croatia
        • Investigational Site 160204
      • Osijek, Croatia
        • Investigational Site 160202
      • Rijeka, Croatia
        • Investigational Site 160205
      • Slavonski Brod, Croatia
        • Investigational Site 160206
      • Zagreb, Croatia
        • Investigational Site 160202
      • Zagreb, Croatia
        • Investigational Site 160207
  • Georgia
      • Batumi, Georgia, 6010
        • Investigational Site 160507
      • Tbilisi, Georgia
        • Investigational Site 160501
      • Tbilisi, Georgia
        • Investigational Site 160502
      • Tbilisi, Georgia
        • Investigational Site 160503
      • Tbilisi, Georgia
        • Investigational Site 160505
      • Tbilisi, Georgia
        • Investigational Site 160506
  • Latvia
      • Liepāja, Latvia
        • Investigational Site 160802
      • Riga, Latvia
        • Investigational Site 160801
      • Riga, Latvia
        • Investigational Site 160803
  • Poland
      • Bydgoszcz, Poland
        • Investigational Site 161025
      • Chojnice, Poland
        • Investigational Site 161008
      • Grudziądz, Poland
        • Investigational Site 161013
      • Kielce, Poland
        • Investigational Site 161029
      • Knurów, Poland
        • Investigational Site 161018
      • Krakow, Poland
        • Investigational Site 161035
      • Ksawerów, Poland
        • Investigational Site 1614011
      • Kłodzko, Poland
        • Investigational Site 161028
      • Lodz, Poland
        • Investigational Site 161037
      • Lublin, Poland
        • Investigational Site 161015
      • Olsztyn, Poland
        • Investigational Site 161033
      • Piotrkow Trybunalski, Poland
        • Investigational Site 161021
      • Poznan, Poland
        • Investigational Site 161022
      • Rzeszów, Poland
        • Investigational Site 161023
      • Rzeszów, Poland
        • Investigational Site 161024
      • Sopot, Poland
        • Investigational Site 161009
      • Swidnica, Poland
        • Investigational Site 161014
      • Szczecin, Poland
        • Investigational Site 161010
      • Torun, Poland
        • Investigational Site 161005
      • Tychy, Poland
        • Investigational Site 161017
      • Warsaw, Poland
        • Investigational Site 161007
      • Warsaw, Poland
        • Investigational Site 161012
      • Warsaw, Poland
        • Investigational Site 161016
      • Warsaw, Poland
        • Investigational Site 161041
      • Wroclaw, Poland
        • Investigational Site 161006
      • Wroclaw, Poland
        • Investigational Site 161040
      • Zamość, Poland
        • Investigational Site 161026
  • Romania
      • Constanța, Romania
        • Investigational Site 161102
      • Timișoara, Romania
        • Investigational Site 161101
      • Târgu Mureş, Romania
        • Investigational Site 161103
  • Serbia
      • Belgrade, Serbia
        • Investigational Site 161201
      • Belgrade, Serbia
        • Investigational Site 161203
      • Belgrade, Serbia
        • Investigational Site 161204
      • Belgrade, Serbia
        • Investigational Site 161206
      • Belgrade, Serbia
        • Investigational Site 161209
      • Leskovac, Serbia
        • Investigational Site 161205
      • Niš, Serbia
        • Investigational Site 161211
      • Novi Sad, Serbia
        • Investigational Site 161207
      • Pančevo, Serbia
        • Investigational Site 161202
      • Zrenjanin, Serbia
        • Investigational Site 161208
  • Slovakia
      • Banská Bystrica, Slovakia
        • Investigational Site 161304
      • Bratislava, Slovakia
        • Investigational Site 161303
      • Košice, Slovakia
        • Investigational Site 161301
      • Prešov, Slovakia
        • Investigational Site 161302
      • Rimavská Sobota, Slovakia
        • Investigational Site 161305
      • Trnava, Slovakia
        • Investigational Site 161306
  • Sri Lanka
      • Colombo, Sri Lanka
        • Investigational Site 162204
      • Galle, Sri Lanka
        • Investigational Site 162203
      • Jaffna, Sri Lanka
        • Investigational Site 162206
      • Kandy, Sri Lanka
        • Investigational Site 162205
      • Ragama, Sri Lanka
        • Investigational Site 162201
  • Ukraine
      • Cherkasy, Ukraine
        • Investigational Site 160411
      • Chernivtsi, Ukraine
        • Investigational Site 160401
      • Ivano-Frankivsk, Ukraine
        • Investigational Site 160412
      • Kyiv, 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
      • Lviv, Ukraine
        • Investigational Site 160407
      • Lviv, Ukraine
        • Investigational Site 160409
      • Lviv, Ukraine
        • Investigational Site 160417
      • Uzhhorod, Ukraine
        • Investigational Site 160408
      • Vinnytsia, Ukraine
        • Investigational Site 160403
      • Vinnytsia, Ukraine
        • Investigational Site 160410
      • Vinnytsia, Ukraine
        • Investigational Site 160415
      • Vinnytsia, Ukraine
        • Investigational Site 160421
      • Vinnytsia, Ukraine
        • Investigational Site 160424
      • Zhytomyr, Ukraine
        • Investigational Site 160419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVT16
Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
Biological: AVT16
AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Other Names:
  • AVT16 proposed biosimilar to vedolizumab
Active Comparator: Entyvio
Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
Biological: Vedolizumab
Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
Other Names:
  • Entyvio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response at week 6
Time Frame: Week 6
Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response at week 52
Time Frame: Week 52
Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvotech Swiss AG

Investigators

  • Study Director: Eveline Schurink, Alvotech Swiss AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Actual)

November 25, 2025

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVT16-GL-C01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcerative Colitis

Clinical Trials on AVT16

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe