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Ulcerative ColitisPhase 3NCT06570772

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

A Phase 3 study testing AVT16 and Vedolizumab in people with Ulcerative Colitis, run by Alvotech Swiss AG at 100 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
AVT16 and Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
100 sitesin 11 countries
Study dates
23 Sep 2024to 25 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

100 sites in 11 countries.

100 sites in 11 countries

Poland27 sites

  • Investigational Site 161025

    Bydgoszcz

  • Investigational Site 161008

    Chojnice

  • Investigational Site 161013

    Grudziądz

  • Investigational Site 161029

    Kielce

  • Investigational Site 161028

    Kłodzko

  • Investigational Site 161018

    Knurów

  • Investigational Site 161035

    Krakow

  • Investigational Site 1614011

    Ksawerów

  • Investigational Site 161037

    Lodz

  • Investigational Site 161015

    Lublin

  • Investigational Site 161033

    Olsztyn

  • Investigational Site 161021

    Piotrkow Trybunalski

  • Investigational Site 161022

    Poznan

  • Investigational Site 161023

    Rzeszów

  • Investigational Site 161024

    Rzeszów

  • Investigational Site 161009

    Sopot

  • Investigational Site 161014

    Swidnica

  • Investigational Site 161010

    Szczecin

  • Investigational Site 161005

    Torun

  • Investigational Site 161017

    Tychy

  • Investigational Site 161007

    Warsaw

  • Investigational Site 161012

    Warsaw

  • Investigational Site 161016

    Warsaw

  • Investigational Site 161041

    Warsaw

  • Investigational Site 161006

    Wroclaw

  • Investigational Site 161040

    Wroclaw

  • Investigational Site 161026

    Zamość

Other trials in Poland

Ukraine21 sites

  • Investigational Site 160411

    Cherkasy

  • Investigational Site 160401

    Chernivtsi

  • Investigational Site 160412

    Ivano-Frankivsk

  • Investigational Site 160404

    Kyiv

  • Investigational Site 160405

    Kyiv

  • Investigational Site 160406

    Kyiv

  • Investigational Site 160413

    Kyiv

  • Investigational Site 160416

    Kyiv

  • Investigational Site 160420

    Kyiv

  • Investigational Site 160422

    Kyiv

  • Investigational Site 160425

    Kyiv

  • Investigational Site 160407

    Lviv

  • Investigational Site 160409

    Lviv

  • Investigational Site 160417

    Lviv

  • Investigational Site 160408

    Uzhhorod

  • Investigational Site 160403

    Vinnytsia

  • Investigational Site 160410

    Vinnytsia

  • Investigational Site 160415

    Vinnytsia

  • Investigational Site 160421

    Vinnytsia

  • Investigational Site 160424

    Vinnytsia

  • Investigational Site 160419

    Zhytomyr

Other trials in Ukraine

Serbia10 sites

  • Investigational Site 161201

    Belgrade

  • Investigational Site 161203

    Belgrade

  • Investigational Site 161204

    Belgrade

  • Investigational Site 161206

    Belgrade

  • Investigational Site 161209

    Belgrade

  • Investigational Site 161205

    Leskovac

  • Investigational Site 161211

    Niš

  • Investigational Site 161207

    Novi Sad

  • Investigational Site 161202

    Pančevo

  • Investigational Site 161208

    Zrenjanin

Other trials in Serbia

Bulgaria9 sites

  • Investigational Site 160111

    Burgas

  • Investigational Site 160102

    Pleven

  • Investigational Site 160109

    Rousse

  • Investigational Site 160101

    Sliven

  • Investigational Site 160103

    Sofia

  • Investigational Site 160105

    Sofia

  • Investigational Site 160108

    Sofia

  • Investigational Site 160107

    Stara Zagora

  • Investigational Site 160106

    Vratsa

Other trials in Bulgaria

Croatia6 sites

  • Investigational Site 160204

    Bjelovar

  • Investigational Site 160202

    Osijek

  • Investigational Site 160205

    Rijeka

  • Investigational Site 160206

    Slavonski Brod

  • Investigational Site 160202

    Zagreb

  • Investigational Site 160207

    Zagreb

Other trials in Croatia

Georgia6 sites

  • Investigational Site 160507

    Batumi, 6010

  • Investigational Site 160501

    Tbilisi

  • Investigational Site 160502

    Tbilisi

  • Investigational Site 160503

    Tbilisi

  • Investigational Site 160505

    Tbilisi

  • Investigational Site 160506

    Tbilisi

Other trials in Georgia

Slovakia6 sites

  • Investigational Site 161304

    Banská Bystrica

  • Investigational Site 161303

    Bratislava

  • Investigational Site 161301

    Košice

  • Investigational Site 161302

    Prešov

  • Investigational Site 161305

    Rimavská Sobota

  • Investigational Site 161306

    Trnava

Other trials in Slovakia

Sri Lanka5 sites

  • Investigational Site 162204

    Colombo

  • Investigational Site 162203

    Galle

  • Investigational Site 162206

    Jaffna

  • Investigational Site 162205

    Kandy

  • Investigational Site 162201

    Ragama

Other trials in Sri Lanka

Argentina4 sites

  • Investigational Site 161704

    Ciudad Autónoma de BuenosAires

  • Investigational Site 161702

    Córdoba

  • Investigational Site 161701

    Quilmes

  • Investigational Site 161705

    San Miguel de Tucumán

Other trials in Argentina

Latvia3 sites

  • Investigational Site 160802

    Liepāja

  • Investigational Site 160801

    Riga

  • Investigational Site 160803

    Riga

Other trials in Latvia

Romania3 sites

  • Investigational Site 161102

    Constanța

  • Investigational Site 161103

    Târgu Mureş

  • Investigational Site 161101

    Timișoara

Other trials in Romania

About this study

Official title: 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.

Read the 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.

Being tested
AVT16, Vedolizumab
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AVT16Biological

    Also called AVT16 proposed biosimilar to vedolizumab

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

  • VedolizumabBiological

    Also called Entyvio

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

Study groups in NCT06570772
Study groupRoleWhat they receive
AVT16ExperimentalExperimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)
Receives: Biological: AVT16
EntyvioActive comparatorEntyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
Receives: Biological: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Response at week 6

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

    Measured: Week 6

Secondary outcomes (1)

  1. Clinical Response at week 52

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

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2024
  2. Study start23 Sep 2024
  3. Primary completion25 Nov 2025
  4. Study completion25 Nov 2025

Why it stopped: The study has been terminated based on Sponsor decision. This decision is not related to any safety concerns associated with the investigational products. It is related to the fact that study will be not required for product dossier submission.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06570772
Sponsor's protocol ID
AVT16-GL-C01
Status last verified
Dec 2025
First submitted
22 Aug 2024
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AVT16 and Vedolizumab in people with Ulcerative Colitis, run by Alvotech Swiss AG at 100 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in Poland, Ukraine, Serbia, Bulgaria, Croatia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study has been terminated based on Sponsor decision. This decision is not related to any safety concerns associated with the investigational products. It is related to the fact that study will be not required for product dossier submission.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Response at week 6 (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06570772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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