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

NCT06570772 | Terminated Phase 3 DMC

• 1 other identifier: AVT16-GL-C01
• Study Type: interventional
• Target: 301
• Locations: 11 countries
• Sites: 100

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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Clinical Response at week 6

  Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome

  Week 6

Secondary Outcomes (1)

• Clinical Response at week 52

  Week 52

Study Arms (2)

AVT16

EXPERIMENTAL

Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)

Biological: AVT16

Entyvio

ACTIVE COMPARATOR

Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16

Biological: Vedolizumab

Interventions

AVT16 BIOLOGICAL

AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46

Also known as: AVT16 proposed biosimilar to vedolizumab

AVT16

Vedolizumab BIOLOGICAL

Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46

Also known as: Entyvio

Entyvio

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alvotech Swiss AG: lead

Study Sites (100)

Investigational Site 161704

Ciudad Autónoma de BuenosAires, Argentina

Location

Investigational Site 161702

Córdoba, Argentina

Location

Investigational Site 161701

Quilmes, Argentina

Location

Investigational Site 161705

San Miguel de Tucumán, Argentina

Location

Investigational Site 160111

Burgas, Bulgaria

Location

Investigational Site 160102

Pleven, Bulgaria

Location

Investigational Site 160109

Rousse, Bulgaria

Location

Investigational Site 160101

Sliven, Bulgaria

Location

Investigational Site 160103

Sofia, Bulgaria

Location

Investigational Site 160105

Sofia, Bulgaria

Location

Investigational Site 160108

Sofia, Bulgaria

Location

Investigational Site 160107

Stara Zagora, Bulgaria

Location

Investigational Site 160106

Vratsa, Bulgaria

Location

Investigational Site 160204

Bjelovar, Croatia

Location

Investigational Site 160202

Osijek, Croatia

Location

Investigational Site 160205

Rijeka, Croatia

Location

Investigational Site 160206

Slavonski Brod, Croatia

Location

Investigational Site 160202

Zagreb, Croatia

Location

Investigational Site 160207

Zagreb, Croatia

Location

Investigational Site 160507

Batumi, 6010, Georgia

Location

Investigational Site 160501

Tbilisi, Georgia

Location

Investigational Site 160502

Tbilisi, Georgia

Location

Investigational Site 160503

Tbilisi, Georgia

Location

Investigational Site 160505

Tbilisi, Georgia

Location

Investigational Site 160506

Tbilisi, Georgia

Location

Investigational Site 160802

Liepāja, Latvia

Location

Investigational Site 160801

Riga, Latvia

Location

Investigational Site 160803

Riga, Latvia

Location

Investigational Site 161025

Bydgoszcz, Poland

Location

Investigational Site 161008

Chojnice, Poland

Location

Investigational Site 161013

Grudziądz, Poland

Location

Investigational Site 161029

Kielce, Poland

Location

Investigational Site 161018

Knurów, Poland

Location

Investigational Site 161035

Krakow, Poland

Location

Investigational Site 1614011

Ksawerów, Poland

Location

Investigational Site 161028

Kłodzko, Poland

Location

Investigational Site 161037

Lodz, Poland

Location

Investigational Site 161015

Lublin, Poland

Location

Investigational Site 161033

Olsztyn, Poland

Location

Investigational Site 161021

Piotrkow Trybunalski, Poland

Location

Investigational Site 161022

Poznan, Poland

Location

Investigational Site 161023

Rzeszów, Poland

Location

Investigational Site 161024

Rzeszów, Poland

Location

Investigational Site 161009

Sopot, Poland

Location

Investigational Site 161014

Swidnica, Poland

Location

Investigational Site 161010

Szczecin, Poland

Location

Investigational Site 161005

Torun, Poland

Location

Investigational Site 161017

Tychy, Poland

Location

Investigational Site 161007

Warsaw, Poland

Location

Investigational Site 161012

Warsaw, Poland

Location

Investigational Site 161016

Warsaw, Poland

Location

Investigational Site 161041

Warsaw, Poland

Location

Investigational Site 161006

Wroclaw, Poland

Location

Investigational Site 161040

Wroclaw, Poland

Location

Investigational Site 161026

Zamość, Poland

Location

Investigational Site 161102

Constanța, Romania

Location

Investigational Site 161103

Târgu Mureş, Romania

Location

Investigational Site 161101

Timișoara, Romania

Location

Investigational Site 161201

Belgrade, Serbia

Location

Investigational Site 161203

Belgrade, Serbia

Location

Investigational Site 161204

Belgrade, Serbia

Location

Investigational Site 161206

Belgrade, Serbia

Location

Investigational Site 161209

Belgrade, Serbia

Location

Investigational Site 161205

Leskovac, Serbia

Location

Investigational Site 161211

Niš, Serbia

Location

Investigational Site 161207

Novi Sad, Serbia

Location

Investigational Site 161202

Pančevo, Serbia

Location

Investigational Site 161208

Zrenjanin, Serbia

Location

Investigational Site 161304

Banská Bystrica, Slovakia

Location

Investigational Site 161303

Bratislava, Slovakia

Location

Investigational Site 161301

Košice, Slovakia

Location

Investigational Site 161302

Prešov, Slovakia

Location

Investigational Site 161305

Rimavská Sobota, Slovakia

Location

Investigational Site 161306

Trnava, Slovakia

Location

Investigational Site 162204

Colombo, Sri Lanka

Location

Investigational Site 162203

Galle, Sri Lanka

Location

Investigational Site 162206

Jaffna, Sri Lanka

Location

Investigational Site 162205

Kandy, Sri Lanka

Location

Investigational Site 162201

Ragama, Sri Lanka

Location

Investigational Site 160411

Cherkasy, Ukraine

Location

Investigational Site 160401

Chernivtsi, Ukraine

Location

Investigational Site 160412

Ivano-Frankivsk, Ukraine

Location

Investigational Site 160404

Kyiv, Ukraine

Location

Investigational Site 160405

Kyiv, Ukraine

Location

Investigational Site 160406

Kyiv, Ukraine

Location

Investigational Site 160413

Kyiv, Ukraine

Location

Investigational Site 160416

Kyiv, Ukraine

Location

Investigational Site 160420

Kyiv, Ukraine

Location

Investigational Site 160422

Kyiv, Ukraine

Location

Investigational Site 160425

Kyiv, Ukraine

Location

Investigational Site 160407

Lviv, Ukraine

Location

Investigational Site 160409

Lviv, Ukraine

Location

Investigational Site 160417

Lviv, Ukraine

Location

Investigational Site 160408

Uzhhorod, Ukraine

Location

Investigational Site 160403

Vinnytsia, Ukraine

Location

Investigational Site 160410

Vinnytsia, Ukraine

Location

Investigational Site 160415

Vinnytsia, Ukraine

Location

Investigational Site 160421

Vinnytsia, Ukraine

Location

Investigational Site 160424

Vinnytsia, Ukraine

Location

Investigational Site 160419

Zhytomyr, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Eveline Schurink

  Alvotech Swiss AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 23, 2024
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SL (6); SE (10); SR (5); GE (6); CR (6); AR (4); UA (21); LA (3); BU (9); PL (27); RO (3)