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New biosimilar AVT16 takes on entyvio for ulcerative colitis

NCT ID NCT06570772

Disease control Sponsor: Alvotech Swiss AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial compared AVT16, a proposed biosimilar, to the approved drug Entyvio (vedolizumab) in 301 adults with moderate to severe ulcerative colitis. Participants received IV infusions over nearly a year. The study aimed to see if AVT16 works as well and is as safe as Entyvio. However, the trial was terminated early, so final results may be limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AVT16 (a proposed biosimilar to vedolizumab)
What this could lead to
If AVT16 works as well as Entyvio, it could offer a more affordable treatment option for ulcerative colitis.
What could go wrong
The trial was terminated early, so results may be incomplete. Biosimilars can differ slightly from the original drug, and this is still being tested.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

301 people

The number who actually took part.

Started

Sep 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Investigational Site 160101

    Sliven, Bulgaria

  • Investigational Site 160102

    Pleven, Bulgaria

  • Investigational Site 160103

    Sofia, Bulgaria

  • Investigational Site 160105

    Sofia, Bulgaria

  • Investigational Site 160106

    Vratsa, Bulgaria

  • Investigational Site 160107

    Stara Zagora, Bulgaria

  • Investigational Site 160108

    Sofia, Bulgaria

  • Investigational Site 160109

    Rousse, Bulgaria

  • Investigational Site 160111

    Burgas, Bulgaria

  • Investigational Site 160202

    Osijek, Croatia

  • Investigational Site 160202

    Zagreb, Croatia

  • Investigational Site 160204

    Bjelovar, Croatia

  • Investigational Site 160205

    Rijeka, Croatia

  • Investigational Site 160206

    Slavonski Brod, Croatia

  • Investigational Site 160207

    Zagreb, Croatia

  • Investigational Site 160401

    Chernivtsi, Ukraine

  • Investigational Site 160403

    Vinnytsia, Ukraine

  • Investigational Site 160404

    Kyiv, Ukraine

  • Investigational Site 160405

    Kyiv, Ukraine

  • Investigational Site 160406

    Kyiv, Ukraine

  • Investigational Site 160407

    Lviv, Ukraine

  • Investigational Site 160408

    Uzhhorod, Ukraine

  • Investigational Site 160409

    Lviv, Ukraine

  • Investigational Site 160410

    Vinnytsia, Ukraine

  • Investigational Site 160411

    Cherkasy, Ukraine

  • Investigational Site 160412

    Ivano-Frankivsk, Ukraine

  • Investigational Site 160413

    Kyiv, Ukraine

  • Investigational Site 160415

    Vinnytsia, Ukraine

  • Investigational Site 160416

    Kyiv, Ukraine

  • Investigational Site 160417

    Lviv, Ukraine

  • Investigational Site 160419

    Zhytomyr, Ukraine

  • Investigational Site 160420

    Kyiv, Ukraine

  • Investigational Site 160421

    Vinnytsia, Ukraine

  • Investigational Site 160422

    Kyiv, Ukraine

  • Investigational Site 160424

    Vinnytsia, Ukraine

  • Investigational Site 160425

    Kyiv, Ukraine

  • 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 160507

    Batumi, 6010, Georgia

  • Investigational Site 160801

    Riga, Latvia

  • Investigational Site 160802

    Liepāja, Latvia

  • Investigational Site 160803

    Riga, Latvia

  • Investigational Site 161005

    Torun, Poland

  • Investigational Site 161006

    Wroclaw, Poland

  • Investigational Site 161007

    Warsaw, Poland

  • Investigational Site 161008

    Chojnice, Poland

  • Investigational Site 161009

    Sopot, Poland

  • Investigational Site 161010

    Szczecin, Poland

  • Investigational Site 161012

    Warsaw, Poland

  • Investigational Site 161013

    Grudziądz, Poland

  • Investigational Site 161014

    Swidnica, Poland

  • Investigational Site 161015

    Lublin, Poland

  • Investigational Site 161016

    Warsaw, Poland

  • Investigational Site 161017

    Tychy, Poland

  • Investigational Site 161018

    Knurów, Poland

  • Investigational Site 161021

    Piotrkow Trybunalski, Poland

  • Investigational Site 161022

    Poznan, Poland

  • Investigational Site 161023

    Rzeszów, Poland

  • Investigational Site 161024

    Rzeszów, Poland

  • Investigational Site 161025

    Bydgoszcz, Poland

  • Investigational Site 161026

    Zamość, Poland

  • Investigational Site 161028

    Kłodzko, Poland

  • Investigational Site 161029

    Kielce, Poland

  • Investigational Site 161033

    Olsztyn, Poland

  • Investigational Site 161035

    Krakow, Poland

  • Investigational Site 161037

    Lodz, Poland

  • Investigational Site 161040

    Wroclaw, Poland

  • Investigational Site 161041

    Warsaw, Poland

  • Investigational Site 161101

    Timișoara, Romania

  • Investigational Site 161102

    Constanța, Romania

  • Investigational Site 161103

    Târgu Mureş, Romania

  • Investigational Site 161201

    Belgrade, Serbia

  • Investigational Site 161202

    Pančevo, Serbia

  • Investigational Site 161203

    Belgrade, Serbia

  • Investigational Site 161204

    Belgrade, Serbia

  • Investigational Site 161205

    Leskovac, Serbia

  • Investigational Site 161206

    Belgrade, Serbia

  • Investigational Site 161207

    Novi Sad, Serbia

  • Investigational Site 161208

    Zrenjanin, Serbia

  • Investigational Site 161209

    Belgrade, Serbia

  • Investigational Site 161211

    Niš, Serbia

  • Investigational Site 161301

    Košice, Slovakia

  • Investigational Site 161302

    Prešov, Slovakia

  • Investigational Site 161303

    Bratislava, Slovakia

  • Investigational Site 161304

    Banská Bystrica, Slovakia

  • Investigational Site 161305

    Rimavská Sobota, Slovakia

  • Investigational Site 161306

    Trnava, Slovakia

  • Investigational Site 1614011

    Ksawerów, Poland

  • Investigational Site 161701

    Quilmes, Argentina

  • Investigational Site 161702

    Córdoba, Argentina

  • Investigational Site 161704

    Ciudad Autónoma de BuenosAires, Argentina

  • Investigational Site 161705

    San Miguel de Tucumán, Argentina

  • Investigational Site 162201

    Ragama, Sri Lanka

  • Investigational Site 162203

    Galle, Sri Lanka

  • Investigational Site 162204

    Colombo, Sri Lanka

  • Investigational Site 162205

    Kandy, Sri Lanka

  • Investigational Site 162206

    Jaffna, Sri Lanka

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