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

Last updated: January 9, 2025
Sponsor: Alvotech Swiss AG
Overall Status: Active - Recruiting

Phase

3

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Ulcers

Treatment

AVT16

Vedolizumab

Clinical Study ID

NCT06570772
AVT16-GL-C01
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of giving signed informed consent

  • Male and female subjects from 18 to 80 years of age

  • Diagnosis of Ulcerative Colitis

Exclusion

Exclusion Criteria:

  • Diagnosis of Crohn's colitis

  • Extensive colonic resection

  • Active or latent tuberculosis

Study Design

Total Participants: 748
Treatment Group(s): 2
Primary Treatment: AVT16
Phase: 3
Study Start date:
September 23, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Investigational Site 161704

    Ciudad Autónoma de BuenosAires,
    Argentina

    Site Not Available

  • Investigational Site 161702

    Cordoba,
    Argentina

    Site Not Available

  • Investigational Site 161701

    Quilmes,
    Argentina

    Site Not Available

  • Investigational Site 161705

    Tucumán,
    Argentina

    Site Not Available

  • Investigational Site 160111

    Burgas,
    Bulgaria

    Site Not Available

  • Investigational Site 160102

    Pleven,
    Bulgaria

    Site Not Available

  • Investigational Site 160109

    Ruse,
    Bulgaria

    Site Not Available

  • Investigational Site 160101

    Sliven,
    Bulgaria

    Site Not Available

  • Investigational Site 160103

    Sofia,
    Bulgaria

    Site Not Available

  • Investigational Site 160105

    Sofia,
    Bulgaria

    Site Not Available

  • Investigational Site 160108

    Sofia,
    Bulgaria

    Site Not Available

  • Investigational Site 160107

    Stara Zagora,
    Bulgaria

    Site Not Available

  • Investigational Site 160106

    Vratsa,
    Bulgaria

    Site Not Available

  • Investigational Site 160204

    Bjelovar,
    Croatia

    Site Not Available

  • Investigational Site 160202

    Osijek,
    Croatia

    Site Not Available

  • Investigational Site 160205

    Rijeka,
    Croatia

    Site Not Available

  • Investigational Site 160206

    Slavonski Brod,
    Croatia

    Site Not Available

  • Investigational Site 160202

    Zagreb,
    Croatia

    Site Not Available

  • Investigational Site 160207

    Zagreb,
    Croatia

    Site Not Available

  • Batumi Referral Hospital/JSC Evex Clinics

    Batumi, 6010
    Georgia

    Site Not Available

  • Investigational Site 160507

    Batumi, 6010
    Georgia

    Site Not Available

  • Investigational Site 160501

    Tbilisi,
    Georgia

    Active - Recruiting

  • Investigational Site 160502

    Tbilisi,
    Georgia

    Site Not Available

  • Investigational Site 160503

    Tbilisi,
    Georgia

    Site Not Available

  • Investigational Site 160505

    Tbilisi,
    Georgia

    Site Not Available

  • Investigational Site 160506

    Tbilisi,
    Georgia

    Active - Recruiting

  • Investigational Site 160802

    Liepāja,
    Latvia

    Active - Recruiting

  • Investigational Site 160801

    Riga,
    Latvia

    Active - Recruiting

  • Investigational Site 160803

    Riga,
    Latvia

    Active - Recruiting

  • Investigational Site 161025

    Bydgoszcz,
    Poland

    Active - Recruiting

  • Investigational Site 161008

    Chojnice,
    Poland

    Active - Recruiting

  • Investigational Site 161013

    Grudziądz,
    Poland

    Site Not Available

  • Investigational Site 161029

    Kielce,
    Poland

    Site Not Available

  • Investigational Site 161018

    Knurów,
    Poland

    Site Not Available

  • Investigational Site 161035

    Kraków,
    Poland

    Site Not Available

  • Investigational Site 1614011

    Ksawerów,
    Poland

    Active - Recruiting

  • Investigational Site 161028

    Kłodzko,
    Poland

    Site Not Available

  • Investigational Site 161015

    Lublin,
    Poland

    Site Not Available

  • Investigational Site 161033

    Olsztyn,
    Poland

    Active - Recruiting

  • Investigational Site 161021

    Piotrków Trybunalski,
    Poland

    Active - Recruiting

  • Investigational Site 161022

    Poznań,
    Poland

    Site Not Available

  • Investigational Site 161023

    Rzeszów,
    Poland

    Active - Recruiting

  • Investigational Site 161024

    Rzeszów,
    Poland

    Active - Recruiting

  • Investigational Site 161009

    Sopot,
    Poland

    Active - Recruiting

  • Investigational Site 161010

    Szczecin,
    Poland

    Active - Recruiting

  • Investigational Site 161005

    Toruń,
    Poland

    Site Not Available

  • Investigational Site 161017

    Tychy,
    Poland

    Active - Recruiting

  • Investigational Site 161007

    Warsaw,
    Poland

    Site Not Available

  • Investigational Site 161012

    Warsaw,
    Poland

    Active - Recruiting

  • Investigational Site 161016

    Warsaw,
    Poland

    Active - Recruiting

  • Investigational Site 161041

    Warsaw,
    Poland

    Active - Recruiting

  • Investigational Site 161006

    Wrocław,
    Poland

    Active - Recruiting

  • Investigational Site 161040

    Wrocław,
    Poland

    Active - Recruiting

  • Investigational Site 161026

    Zamość,
    Poland

    Active - Recruiting

  • Investigational Site 161037

    Łódź,
    Poland

    Site Not Available

  • Investigational Site 161014

    Świdnica,
    Poland

    Site Not Available

  • Investigational Site 161102

    Constanţa,
    Romania

    Site Not Available

  • Investigational Site 161101

    Timişoara,
    Romania

    Site Not Available

  • Investigational Site 161103

    Târgu-Mureş,
    Romania

    Site Not Available

  • Investigational Site 161201

    Belgrade,
    Serbia

    Site Not Available

  • Investigational Site 161203

    Belgrade,
    Serbia

    Site Not Available

  • Investigational Site 161204

    Belgrade,
    Serbia

    Site Not Available

  • Investigational Site 161206

    Belgrade,
    Serbia

    Site Not Available

  • Investigational Site 161209

    Belgrade,
    Serbia

    Site Not Available

  • Investigational Site 161205

    Leskovac,
    Serbia

    Site Not Available

  • Investigational Site 161211

    Niš,
    Serbia

    Site Not Available

  • Investigational Site 161207

    Novi Sad,
    Serbia

    Site Not Available

  • Investigational Site 161202

    Pančevo,
    Serbia

    Site Not Available

  • Investigational Site 161208

    Zrenjanin,
    Serbia

    Site Not Available

  • Investigational Site 161304

    Banská Bystrica,
    Slovakia

    Active - Recruiting

  • Investigational Site 161303

    Bratislava,
    Slovakia

    Active - Recruiting

  • Investigational Site 161301

    Košice,
    Slovakia

    Active - Recruiting

  • Investigational Site 161302

    Prešov,
    Slovakia

    Active - Recruiting

  • Investigational Site 161305

    Rimavská Sobota,
    Slovakia

    Site Not Available

  • Investigational Site 161306

    Trnava,
    Slovakia

    Active - Recruiting

  • Investigational Site 162204

    Colombo,
    Sri Lanka

    Site Not Available

  • Investigational Site 162203

    Galle,
    Sri Lanka

    Site Not Available

  • Investigational Site 162206

    Jaffna,
    Sri Lanka

    Site Not Available

  • Investigational Site 162205

    Kandy,
    Sri Lanka

    Site Not Available

  • Investigational Site 162201

    Ragama,
    Sri Lanka

    Site Not Available

  • Investigational Site 160411

    Cherkasy,
    Ukraine

    Active - Recruiting

  • Investigational Site 160401

    Chernivtsi,
    Ukraine

    Site Not Available

  • Investigational Site 160412

    Ivano-Frankivs'k,
    Ukraine

    Active - Recruiting

  • Investigational Site 160404

    Kyiv,
    Ukraine

    Active - Recruiting

  • Investigational Site 160405

    Kyiv,
    Ukraine

    Site Not Available

  • Investigational Site 160406

    Kyiv,
    Ukraine

    Active - Recruiting

  • Investigational Site 160413

    Kyiv,
    Ukraine

    Active - Recruiting

  • Investigational Site 160416

    Kyiv,
    Ukraine

    Site Not Available

  • Investigational Site 160420

    Kyiv,
    Ukraine

    Site Not Available

  • Investigational Site 160422

    Kyiv,
    Ukraine

    Site Not Available

  • Investigational Site 160425

    Kyiv,
    Ukraine

    Site Not Available

  • Investigational Site 160407

    Lviv,
    Ukraine

    Site Not Available

  • Investigational Site 160409

    Lviv,
    Ukraine

    Active - Recruiting

  • Investigational Site 160417

    Lviv,
    Ukraine

    Active - Recruiting

  • Investigational Site 160403

    Vinnytsia,
    Ukraine

    Site Not Available

  • Investigational Site 160410

    Vinnytsia,
    Ukraine

    Active - Recruiting

  • Investigational Site 160415

    Vinnytsia,
    Ukraine

    Site Not Available

  • Investigational Site 160421

    Vinnytsia,
    Ukraine

    Active - Recruiting

  • Investigational Site 160424

    Vinnytsia,
    Ukraine

    Site Not Available

  • Investigational Site 160419

    Zhytomyr,
    Ukraine

    Site Not Available

  • Investigational Site 160408

    Úzhgorod,
    Ukraine

    Active - Recruiting

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