AzTrials
AzTrials

Crohn's DiseasePhase 3VICTRIVANCT06227910

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

A Phase 3 study testing Vedolizumab and Upadacitinib in people with Crohn's Disease, run by Takeda at 138 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Crohn's Disease
What is being tested?
Vedolizumab and Upadacitinib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
396 participants
Where
138 sitesin 26 countries
Study dates
2 Jan 2025to 1 Aug 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
  • The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
  • The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of >=6 (or >=4 for participants with isolated ileal disease), as confirmed by a central reader.
  • The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.

Who cannot join

  • The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
  • The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline.
  • The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection.
  • The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
  • The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
  • The participant has an ostomy or ileoanal pouch.
  • The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).
  • The participant has severe (Child-Pugh C) hepatic impairment.

Trial locations and contacts

138 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Takeda Contact contact

+1-877-825-3327

medinfoUS@takeda.com

138 sites in 26 countries

United States19 sites, 9 recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    Site Contact, 719-310-6719, bpatel@peakgastro.com

    Bhaktasharan Patel

    Recruiting

  • Gastroenterology Associates

    Greenville, South Carolina, 29607

    Active, not recruiting

  • Indiana University (IU) Health University Hospital

    Indianapolis, Indiana, 46202

    Active, not recruiting

  • UCSD Medical Center

    La Jolla, California, 92037

    Site Contact, 858-246-2544, sis040@health.ucsd.edu

    Siddharth Singh

    Not yet recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Active, not recruiting

  • Keck Medicine Of USC - USC Healthcare Center 1

    Los Angeles, California, 90033

    Site Contact, 888-700-5700, sarah.sheibani@med.usc.edu

    Sarah Sheibani

    Not yet recruiting

  • Medical College of Wisconsin Cancer Center - Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Site Contact, 414-955-6827, pbeniwal@mcw.edu

    Poonam Beniwal-Patel

    Not yet recruiting

  • GI PROS, Inc.

    Naples, Florida, 34102

    Active, not recruiting

  • Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center

    New York, New York, 10029-5204

    Active, not recruiting

  • Columbia University Medical Center, New York-Presbyterian Hospital

    New York, New York, 10032

    Site Contact, 212-305-9664, bs3270@cumc.columbia.edu

    Bo Shen

    Not yet recruiting

  • Lenox Hill Hospital Northwell Health

    New York, New York, 10075

    Active, not recruiting

  • Orlando Health Ambulatory Care Center

    Orlando, Florida, 32806

    Active, not recruiting

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

    Active, not recruiting

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

    Site Contact, 210-581-2812, js_bull@yahoo.com

    Jeff Bullock

    Recruiting

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

    Active, not recruiting

  • Swedish Cancer Institute

    Seattle, Washington, 98104

    Site Contact, 206-215-4250, michael.chiorean@swedish.org

    Michael Chiorean

    Not yet recruiting

  • University of Washington Medical Center - Montlake

    Seattle, Washington, 98195

    Site Contact, 206-543-3500, scottl@medicine.washington.edu

    Scott Lee

    Not yet recruiting

  • USF Health Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

    Active, not recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

    Site Contact, 903-630-6211, aarond@tylerri.com

    George Duvall

    Recruiting

Other trials in United States

Canada9 sites, 7 recruiting

  • Barrie GI Associates

    Barrie, Ontario, L4M 7G1

    Site Contact, 17057213344, petroniener@barriegi.ca

    Rima Petroniene

    Recruiting

  • Heritage Medical Research Clinic - University Of Calgary

    Calgary, Alberta, T2N 4Z6

    Active, not recruiting

  • Dalhousie University

    Halifax, Nova Scotia, B3H 2Y9

    Site Contact, 9024732612, Michael.stewart@dal.ca

    Michael Stewart

    Not yet recruiting

  • McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)

    Hamilton, Ontario, L8S 4K1

    Active, not recruiting

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 0A9

    Site Contact, 5142953671, robert.battat@umontreal.ca

    Robert Battat

    Not yet recruiting

  • Taunton Surgical Centre-Oshawa Clinic

    Oshawa, Ontario, L1J 0C7

    Site Contact, 905-721-4964, daniel@drgreengi.com

    Daniel Green

    Recruiting

  • Toronto Immune and Digestive Health Institute (TIDHI)

    Toronto, Ontario, M6A 3B4

    Site Contact, 6478122113, pi_research@tidhi.ca

    Mark Silverberg

    Recruiting

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4Y7

    Site Contact, 4166500017, dford@tdda.ca

    David Ford

    Not yet recruiting

  • University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

    Site Contact, 2047872060, charles.bernstein@umanitoba.ca

    Charles Bernstein

    Not yet recruiting

Other trials in Canada

France8 sites, 5 recruiting

  • CHU d'Amiens-Picardie - Hopital SUD

    Amiens, 80054

    Site Contact, 330322088849, fumery.mathurin@chu-amiens.fr

    Mathurin Fumery

    Not yet recruiting

  • Hopital Huriez - CHRU de Lille

    Lille, 59037

    Site Contact, 33320445321, maria.nachury@chru-lille.fr

    Maria Nachury

    Not yet recruiting

  • Chu - Hopital Nord

    Marseille, 13015

    Site Contact, 330491968737, melanie.serrero@ap-hm.fr

    Melanie Serrero

    Not yet recruiting

  • Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu

    Nantes, 44093

    Active, not recruiting

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

    Pessac, 33600

    Active, not recruiting

  • CHU St Etienne Hopital Nord

    Saint-Etienne, 42270

    Site Contact, 330477127348, xavier.roblin@chu-st-etienne.fr

    Xavier Roblin

    Not yet recruiting

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil

    Toulouse, 31059

    Active, not recruiting

  • Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

    Site Contact, 33383157450, peyrinbiroulet@gmail.com

    Laurent Peyrin Biroulet

    Not yet recruiting

Other trials in France

South Korea8 sites, 2 recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Site Contact, 10 9330 2333, kto0440@paik.ac.kr

    Tae-Oh Kim

    Recruiting

  • Yeungnam University Medical Center

    Daegu, 42415

    Active, not recruiting

  • The Catholic University of Korea, Daejeon St.Mary's Hospital

    Daejeon, 34943

    Active, not recruiting

  • Kyung Hee University Hospital

    Seoul, 02447

    Site Contact, 2 958 8238, gidrlee@gmail.com

    Chang Kyun Lee

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Active, not recruiting

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

    Active, not recruiting

  • Chung-Ang University Hospital

    Seoul, 06973

    Active, not recruiting

  • The Catholic University Of Korea, St. Vincent's Hospital

    Suwon, 16247

    Active, not recruiting

Other trials in South Korea

Brazil7 sites, 7 recruiting

  • Faculdade de Medicina de Botucatu

    Botucatu, São Paulo, 18618-970

    Site Contact, 1438801171, ligiasassaki@gmail.com

    Ligia Yukie Sassaki

    Not yet recruiting

  • Hospital Universitario Cajuru

    Curitiba, Paraná, 80050-350

    Site Contact, +55 4132537838, pgkotze@hotmail.com

    Paulo Kotze

    Not yet recruiting

  • Centro de Estudos Clinico do Interior Paulista - CECIP

    Jaú, São Paulo, 17201130

    Site Contact, +55 14 3622-0500; 98116-9078, brunameyercecip@gmail.com

    Bruna Meyer de Mattos

    Not yet recruiting

  • Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)

    Rio de Janeiro, 21941-617

    Site Contact, +552139382417, c.zaltman@gmail.com

    Cyrla Zaltman

    Not yet recruiting

  • Pesquisare Saude

    Santo André, São Paulo, 9080110

    Site Contact, 11981118990, alexander@rolim.med.br

    Alexander de Sa Rolim

    Not yet recruiting

  • Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC/FMUSP))

    São Paulo, 05403-010

    Site Contact, +55 11 97187 1131, luisa.barros@hc.fm.usp.br

    Luisa Leite Barros

    Not yet recruiting

  • Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

    São Paulo, 1405-1243

    Site Contact, 1636022956, rogeriosparra@gmail.com

    Rogerio Parra

    Not yet recruiting

Other trials in Brazil

Germany7 sites, 7 recruiting

  • Krankenhaus Waldfriede e.V.

    Berlin, 14163

    Site Contact, 4930818108243, c.buening@waldfriede.de

    Carsten Buening

    Not yet recruiting

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

    Site Contact, 496995332201, axel.dignass@agaplesion.de

    Axel Dignass

    Not yet recruiting

  • Studiengesellschaft BSF

    Halle, 06108

    Site Contact, 493456299716, dr.fechner@bsf-halle.de

    Lars Fechner

    Not yet recruiting

  • Universitaetsklinikum Jena

    Jena, 07747

    Site Contact, 4936419324401, andreas.stallmach@med.uni-jena.de

    Andreas Stallmach

    Not yet recruiting

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105

    Site Contact, 4943150022457, s.schreiber@mucosa.de

    Stefan Schreiber

    Not yet recruiting

  • St. Marien- und St. Annastiftskrankenhaus

    Ludwigshafen, 67065

    Site Contact, 4962155012224, tanja.kuehbacher@st-marienkrankenhaus.de

    Tanja Kuehbacher

    Not yet recruiting

  • Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik

    Mannheim, 68167

    Site Contact, 496213833294, wolfgang.reindl@umm.de

    Wolfgang Reindl

    Not yet recruiting

Other trials in Germany

Italy6 sites, 6 recruiting

  • Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele

    Milan, 20132

    Site Contact, 282245555, ibd.trials@hsr.it

    Silvio Danese

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Federico II di Napoli

    Naples, 80131

    Site Contact, 817463849, fabcasti@unina.it

    Fabiana Castiglione

    Not yet recruiting

  • A. Gemelli University Hospital, Catholic University of the Sacred Heart

    Roma, 00168

    Site Contact, 630156265, antonio.gasbarrini@unicatt.it

    Antonio Gasbarrini

    Not yet recruiting

  • Humanitas Clinical And Research Institute

    Rozzano, 20089

    Site Contact, 630159357, alessandro.armuzzi@hunimed.eu

    Alessandro Armuzzi

    Not yet recruiting

  • Fondazione IRCSS Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013

    Site Contact, 882410335, f.bossa@operapadrepio.it

    Fabrizio Bossa

    Not yet recruiting

  • AO Ordine Mauriziano di Torino

    Torino, 10122

    Site Contact, 115082534, mdaperno@gmail.com

    Marco Daperno

    Not yet recruiting

Other trials in Italy

Spain6 sites, 3 recruiting

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007

    Active, not recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Active, not recruiting

  • Hospital Universitari Son Espases

    Palma, 07120

    Site Contact, 629349802, daniel.ginard@gmail.com

    Daniel Ginard Vicens

    Not yet recruiting

  • Complejo Hospitalario de Navarra (CHN)

    Pamplona, 31008

    Active, not recruiting

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706

    Site Contact, 981951370, manuel.barreiro.de.acosta@sergas.es

    Manuel Francisco Barreiro de Acosta

    Not yet recruiting

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026

    Site Contact, 34961244000, pilar.nos@gmail.com

    Pilar Nos Mateu

    Not yet recruiting

Other trials in Spain

Taiwan6 sites, 6 recruiting

  • Changhua Christian Hospital

    Changhua, 50006

    Site Contact, 47238595, 91646@cch.org.tw

    Hsu-Heng Yen

    Not yet recruiting

  • Chung Shan Medical University Hospital

    Taichung, 40201

    Site Contact, 424739595, a0982224141@gmail.com

    Ching-Pi Lin

    Not yet recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Site Contact, 975358977, b8501122@tmu.edu.tw

    Chung-Hsin Chang

    Not yet recruiting

  • National Cheng Kung University Hospital

    Tainan, 70403

    Site Contact, 972401167, jasonc@mail.ncku.edu.tw

    Chiao-Hsiung Chuang

    Not yet recruiting

  • National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu

    Taipei, 11490

    Site Contact, 937543027, tienyu27@gmail.com

    Tien-Yu Huang

    Not yet recruiting

  • Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33305

    Site Contact, 33281200 ext. 8101, ctchiu@adm.cgmh.org.tw

    Cheng-Tang Chiu

    Not yet recruiting

Other trials in Taiwan

Austria5 sites, 5 recruiting

  • Medical University Innsbruck

    Innsbruck, Tyrol, 6020

    Site Contact, 51250481311, robert.koch@i-med.ac.at

    Robert Koch

    Not yet recruiting

  • Johannes Kepler Universitat Linz (JKU)

    Linz, 4021

    Site Contact, 57680836120, alexander.moschen@kepleruniklinikum.at

    Alexander Moschen

    Not yet recruiting

  • Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss

    Salzburg, 5020

    Site Contact, 5725525410, s.heeren@salk.at

    Sonja Heeren

    Not yet recruiting

  • Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III

    Vienna, State of Vienna, 1090

    Site Contact, 14040047440, walter.reinisch@meduniwien.ac.at

    Walter Reinisch

    Not yet recruiting

  • Krankenhaus der Barmherzigen Brueder Wien

    Vienna, 1020

    Site Contact, 1404004735, aesere58@live.com

    Alexander Eser

    Not yet recruiting

Other trials in Austria

Belgium5 sites, 4 recruiting

  • Imelda GI Clinical Research Center

    Bonheiden, 2820

    Active, not recruiting

  • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel

    Brussels, Anderlecht, 1070

    Site Contact, 25553111, denis.franchimont@erasme.ulb.ac.be

    Denis Franchimont

    Not yet recruiting

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Site Contact, +32 93329500, Triana.LobatonOrtega@uzgent.be

    Triana Lobaton Ortega

    Not yet recruiting

  • University Hospitals Leuven

    Leuven, 3000

    Site Contact, 16344225, marc.ferrante@uzleuven.be

    Marc Ferrante

    Not yet recruiting

  • Centre Hospitalier Chretien MontLegia

    Liège, 4000

    Site Contact, 42248960, arnaud.colard@chc.be

    Arnaud Colard

    Not yet recruiting

Other trials in Belgium

Israel5 sites, 5 recruiting

  • Soroka Medical Center

    Beersheba, 8410101

    Site Contact, 36973270, dorons@tlvmc.gov.il

    Doron Schwartz

    Not yet recruiting

  • Rambam Health Care Campus (RHCC)

    Haifa, 3109601

    Site Contact, +972 48541777, r_weisshof@rambam.health.gov.il

    Roni Weisshof

    Not yet recruiting

  • Meir Medical Center

    Kfar Saba, 44281

    Site Contact, 508767069, michal.openhaim@clalit.org.il

    Michal Openhaim

    Not yet recruiting

  • Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)

    Petah Tikva, 49100

    Site Contact, 545989299, iritab@clalit.org.il

    Irit Avni-Biron

    Not yet recruiting

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

    Site Contact, 522576381, nathanielac@tlvmc.gov.il

    Nathaniel Aviv Cohen

    Not yet recruiting

Other trials in Israel

Poland5 sites, 5 recruiting

  • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153

    Site Contact, 426786480, ewuncia@poczta.onet.pl

    Ewa Malecka-Wojciesko

    Not yet recruiting

  • Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um

    Poznan, 60-354

    Site Contact, 48691240477, piotr.eder@op.pl

    Piotr Eder

    Not yet recruiting

  • H-T. Centrum Medyczne Sp. z o.o. Sp.k.

    Tychy, 43-100

    Site Contact, 322178866, romanczyk@htcentrum.pl

    Tomasz Romanczyk

    Not yet recruiting

  • Panstwowy Instytut Medyczny MSWiA

    Warsaw, 02-507

    Site Contact, 46695666611, grazyna.rydzewska@cskmswia.gov.pl

    Grazyna Rydzewska-Wyszkowska

    Not yet recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 05-401

    Site Contact, 500111648, j.kierkus@med-net.pl

    Jaroslaw Kierkus

    Not yet recruiting

Other trials in Poland

Czechia4 sites, 4 recruiting

  • Nemocnice Ceske Budejovice, a.s.

    České Budějovice, 370 01

    Site Contact, 420777563349, bortlik.martin@nemcb.cz

    Martin Bortlik

    Not yet recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Site Contact, 21127048, tomas.douda@fnhk.cz

    Tomas Douda

    Not yet recruiting

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

    Site Contact, 420603545009, tomas.vanasek@hepato-gastro.com

    Tomas Vanasek

    Not yet recruiting

  • IBD Clinical and Research centre

    Prague, 190 00

    Site Contact, 420725505279, studie.lukas@email.cz

    Milan Lukas

    Not yet recruiting

Other trials in Czechia

Netherlands4 sites, 4 recruiting

  • Amsterdam UMC Research BV

    Amsterdam, 1105 AZ

    Site Contact, 205661768, m.lowenberg@amsterdamumc.nl

    Mark Lowenberg

    Not yet recruiting

  • Radboud University Medical Center

    Nijmegen, 6525 GA

    Site Contact, 243619190, marjolijn.duijvestein@radboudumc.nl

    Marjolijn Duijvestein

    Not yet recruiting

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

    Site Contact, 107040704, a.c.devries@erasmusmc.nl

    Annemarie Vries

    Not yet recruiting

  • Elisabeth TweeSteden Ziekenhuis (ETZ)

    Tilburg, 5022 GC

    Site Contact, 013-2218466, m.lutgens@etz.nl

    Maurice Lutgens

    Not yet recruiting

Other trials in Netherlands

Norway4 sites, 4 recruiting

  • Haukeland Universitetssjukehus (Haukeland University Hospital)

    Bergen, N5021

    Site Contact, 55971147, kim.nylund@helse-bergen.no

    Kim Nylund

    Not yet recruiting

  • Vestre Viken HF - Baerum Sykehus

    Drammen, Gjettum, 1309

    Site Contact, 4791364749, sthvat@vestreviken.no

    Stine Astrup Hvattum

    Not yet recruiting

  • Akershus University Hospital

    Lorenskog, 1478

    Site Contact, 4767969679, stephan.andreas.brackmann@ahus.no

    Stephan Brackmann

    Not yet recruiting

  • Oslo Universitetssykehus HF, Ulleval

    Oslo, 0424

    Site Contact, 4722119260, moliho@ous-hf.no

    Marte Lie Hoivik

    Not yet recruiting

Other trials in Norway

Sweden4 sites, 4 recruiting

  • Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)

    Linköping

    Site Contact, 13223895, henrik.hjortswang@regionostergotland.se

    Henrik Hjortswang

    Not yet recruiting

  • Ersta sjukhus

    Stockholm, 116 30

    Site Contact, 87146700, ann-sofie.backman@erstadiakoni.se

    Ann-Sofie Backman

    Not yet recruiting

  • Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital

    Stockholm, 171 76

    Site Contact, 851770000, charlotte.hedin@ki.se

    Charlotte Hedin

    Not yet recruiting

  • Danderyds Sjukhus AB

    Stockholm, 182 88

    Site Contact, 812358963, mikael.lordal@regionstockholm.se

    Mikael Lordal

    Not yet recruiting

Other trials in Sweden

Switzerland4 sites, 4 recruiting

  • University Hospital Basel

    Basel, 4031

    Site Contact, 41617777421, janhendrik.niess@usb.ch

    Jan Niess

    Not yet recruiting

  • University Hospital Bern (Inselspital)

    Bern, 3010

    Site Contact, 41316325900, niklas.krupka@insel.ch

    Niklas Krupka

    Not yet recruiting

  • Zentrum fur Gastroenterologie

    Zurich, 8048

    Site Contact, 41765931451, stephan.vavricka@hin.ch

    Stephan Vavricka

    Not yet recruiting

  • Universitatsspital Zurich

    Zurich, 8091

    Site Contact, 442551111, luc.biedermann@usz.ch

    Luc Biedermann

    Not yet recruiting

Other trials in Switzerland

United Kingdom4 sites, 4 recruiting

  • Western General Hospital

    Edinburgh, Lothian, EH4 2XU

    Site Contact, 020 7188 7188, charlie.lees@ed.ac.uk

    Charlie Lees

    Not yet recruiting

  • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division

    Glasgow, Scotland, G51 4TF

    Site Contact, jonathan.macdonald@ggc.scot.nhs.uk

    Jonathan MacDonald

    Not yet recruiting

  • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust

    London, England, SE1 7EH

    Site Contact, 7970621263, Peter.Irving@gstt.nhs.uk

    Peter Irving

    Not yet recruiting

  • The Royal London Hospital - Barts Health NHS Trust

    London, Greater London, E1 1BB

    Site Contact, 020 7377 7000, gareth.parkes@nhs.net

    Gareth Parkes

    Not yet recruiting

Other trials in United Kingdom

Croatia3 sites, 2 recruiting

  • Poliklinika Borzan d.o.o.

    Osijek, 31000

    Site Contact, 385915211171, vborzan@hotmail.com

    Vladimir Borzan

    Not yet recruiting

  • Clinical Hospital Center Rijeka

    Rijeka, 51000

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    Zagreb, 10000

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Slovenia1 site, 1 recruiting

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About this study

Official title: A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease

The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants.

All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks.

During the study, participants will visit their study clinic 15 times.

Read the detailed description

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-weeks Induction Phase:

  • Induction Phase: Vedolizumab + Upadacitinib
  • Induction Phase: Vedolizumab + Placebo

Participants who achieve a Crohn's disease activity index (CDAI) reduction of greater than or equal to (>=)70 points from baseline at Week 12 will enter the main study Maintenance Phase (40 weeks) of the study to receive vedolizumab monotherapy. Participants will be followed for a further 18-week safety follow-up period up to Week 70.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks.

Conditions
Crohn's Disease
Being tested
Vedolizumab, Upadacitinib, Placebo
Keywords
Drug Therapy
Medical subject headings
Crohn Disease

What participants receive

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

  • VedolizumabDrug

    Also called Entyvio, MLN0002, KYNTELES

    Vedolizumab IV infusion.

  • UpadacitinibDrug

    Also called Rinvoq

    Upadacitinib over-encapsulated tablets.

  • PlaceboDrug

    Upadacitinib matched placebo capsules.

Study groups in NCT06227910
Study groupRoleWhat they receive
Double-blind Induction Phase: Vedolizumab + UpadacitinibExperimentalParticipants will receive vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, 6 and 10 along with upadacitinib 45 mg, orally, once daily (QD) for 12 weeks.
Receives: Drug: Vedolizumab; Drug: Upadacitinib
Double-blind Induction Phase: Vedolizumab + PlaceboPlacebo comparatorParticipants will receive vedolizumab IV 300 mg infusion, at Weeks 0, 2, 6 and 10 along with upadacitinib matched placebo, orally, QD for 12 weeks.
Receives: Drug: Vedolizumab; Drug: Placebo
Main Study Maintenance Phase: Vedolizumab MonotherapyExperimentalParticipants who achieve a CDAI reduction of >=70 points from baseline at Week 12 will receive vedolizumab 300 mg IV infusion (monotherapy), every 8 weeks (Q8W) starting at Week 14 to 52. The Q8W vedolizumab monotherapy may be escalated to Q4W at the investigator's discretion.
Receives: Drug: Vedolizumab

What is being measured

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

  1. Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12

    Clinical remission is defined as a CDAI score of less than (<) 150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: Week 12

  2. Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12

    Endoscopic response per SES-CD is defined as decrease in SES CD greater than (>) 50% from baseline (or for participants with isolated ileal disease, SES-CD <=4 or a >=2-point reduction in SES-CD from baseline) read centrally. SES-CD evaluates 4 endoscopic variables (ulcer size,percentage of ulcerated and affected surface area, presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum,right,transverse,and left colon,rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. Overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.

    Measured: Week 12

Secondary outcomes (10)

  1. Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Based Clinical Remission at Week 12

    Clinical remission based on PRO2 is defined as 7-day average of very soft or liquid stool frequency (SF) less than or equal to ( <=) 2.8, 7-day average of abdominal pain (AP) score <=1.0, and neither worse than baseline. The PRO2 is comprised of the stool frequency and abdominal pain components of the CDAI.

    Measured: Week 12

  2. Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12

    Endoscopic remission as per SES-CD is defined as a SES-CD score of <=4 and no subscore >1, read centrally. SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.

    Measured: Week 12

  3. Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 12

    Percentage of participants using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission per CDAI at Week 12 will be reported. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: Week 12

  4. Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 12

    Clinical response is defined as >=100-point decrease from baseline in CDAI score. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: Week 12

  5. Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 52

    Clinical remission is defined as a CDAI score of <150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: Week 52

  6. Percentage of Participants Exhibiting an Endoscopic Response Based on SES-CD at Week 52

    Endoscopic response per SES-CD is defined as a decrease in SES CD >50% from baseline (or for participants with isolated ileal disease,SES-CD <=4 or a >=2-point reduction in SES-CD from baseline) read centrally. SES-CD evaluates 4 endoscopic variables (ulcer size,percentage of ulcerated and affected surface area,presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum,right,transverse,and left colon,and rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. Overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.

    Measured: Week 52

  7. Percentage of Participants Achieving 2-item PRO2 Based Clinical Remission at Week 52

    Clinical remission based on PRO2 is defined as 7-day average of very soft or liquid stool frequency (SF) <=2.8, 7-day average of abdominal pain (AP) score <=1.0, and neither worse than baseline. The PRO2 is comprised of the stool frequency and abdominal pain components of the CDAI.

    Measured: Week 52

  8. Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 52

    Endoscopic remission as per SES-CD is defined as a SES-CD score of <=4 and no subscore >1, read centrally . SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of surface area (SA) that is ulcerated, percentage of SA affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy. Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. The overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.

    Measured: Week 52

  9. Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 52

    Percentage of participants using oral corticosteroids at baseline who have discontinued corticosteroids and are in clinical remission at Week 52 per CDAI will be reported. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity

    Measured: Week 52

  10. Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 52

    Clinical response is defined as >=100-point decrease from baseline in CDAI score. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consist of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    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 posted29 Jan 2024
  2. Study start2 Jan 2025
  3. Primary completion8 Jun 2027 (estimated)
  4. Study completion1 Aug 2028 (estimated)

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06227910
Sponsor's protocol ID
Vedolizumab-3043
Other IDs
2023-509391-42-00, 2023
Acronym
VICTRIVA
Status last verified
May 2026
First submitted
19 Jan 2024
Last updated
27 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Publications

  • Danese S, Sands BE, Feagan BG, Jairath V, Panaccione R, Peyrin-Biroulet L, Irving PM, Schreiber S, Dotan I, Ferrante M, D'Haens GR, Jones S, Freire M, Lindner D, Adsul S, Oberai P, Colombel JF. Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease. Contemp Clin Trials Commun. 2025 Nov 24;48:101574. doi: 10.1016/j.conctc.2025.101574. eCollection 2025 Dec.

    PubMed 41403476

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vedolizumab and Upadacitinib in people with Crohn's Disease, run by Takeda at 138 sites in 26 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Canada, France, South Korea, Brazil and 21 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. Some participants in this study may receive a placebo. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. 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 NCT06227910, which also lists 1 linked publication.

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 27 May 2026.

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