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

May 22, 2026 updated by: Takeda

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Not yet recruiting
        • Johannes Kepler Universitat Linz (JKU)
        • Contact:
        • Principal Investigator:
          • Alexander Moschen
      • Salzburg, Austria, 5020
        • Not yet recruiting
        • Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
        • Principal Investigator:
          • Sonja Heeren
        • Contact:
      • Vienna, Austria, 1020
        • Not yet recruiting
        • Krankenhaus der Barmherzigen Brueder Wien
        • Contact:
        • Principal Investigator:
          • Alexander Eser
    • State of Vienna
      • Vienna, State of Vienna, Austria, 1090
        • Not yet recruiting
        • Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
        • Principal Investigator:
          • Walter Reinisch
        • Contact:
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Not yet recruiting
        • Medical University Innsbruck
        • Principal Investigator:
          • Robert Koch
        • Contact:
  • Belgium
      • Bonheiden, Belgium, 2820
        • Active, not recruiting
        • Imelda GI Clinical Research Center
      • Ghent, Belgium, 9000
        • Not yet recruiting
        • Universitair Ziekenhuis Gent
        • Principal Investigator:
          • Triana Lobaton Ortega
        • Contact:
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • University Hospitals Leuven
        • Principal Investigator:
          • Marc Ferrante
        • Contact:
      • Liège, Belgium, 4000
        • Not yet recruiting
        • Centre Hospitalier Chretien MontLegia
        • Principal Investigator:
          • Arnaud Colard
        • Contact:
    • Anderlecht
      • Brussels, Anderlecht, Belgium, 1070
        • Not yet recruiting
        • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
        • Principal Investigator:
          • Denis Franchimont
        • Contact:
  • Brazil
      • Rio de Janeiro, Brazil, 21941-617
        • Not yet recruiting
        • Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
        • Contact:
        • Principal Investigator:
          • Cyrla Zaltman
      • São Paulo, Brazil, 05403-010
        • 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))
        • Contact:
        • Principal Investigator:
          • Luisa Leite Barros
      • São Paulo, Brazil, 1405-1243
        • Not yet recruiting
        • Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
        • Contact:
        • Principal Investigator:
          • Rogerio Parra
    • Paraná
      • Curitiba, Paraná, Brazil, 80050-350
        • Not yet recruiting
        • Hospital Universitario Cajuru
        • Contact:
        • Principal Investigator:
          • Paulo Kotze
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-970
        • Not yet recruiting
        • Faculdade de Medicina de Botucatu
        • Principal Investigator:
          • Ligia Yukie Sassaki
        • Contact:
      • Jaú, São Paulo, Brazil, 17201130
        • Not yet recruiting
        • Centro de Estudos Clinico do Interior Paulista - CECIP
        • Contact:
        • Principal Investigator:
          • Bruna Meyer de Mattos
      • Santo André, São Paulo, Brazil, 9080110
        • Not yet recruiting
        • Pesquisare Saude
        • Principal Investigator:
          • ALEXANDER DE SA ROLIM
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Active, not recruiting
        • Heritage Medical Research Clinic - University Of Calgary
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Not yet recruiting
        • University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
        • Principal Investigator:
          • Charles Bernstein
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Not yet recruiting
        • Dalhousie University
        • Contact:
        • Principal Investigator:
          • Michael Stewart
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • Barrie GI Associates
        • Principal Investigator:
          • Rima Petroniene
        • Contact:
      • Hamilton, Ontario, Canada, L8S 4K1
        • Active, not recruiting
        • McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
      • Oshawa, Ontario, Canada, L1J 0C7
        • Recruiting
        • Taunton Surgical Centre-Oshawa Clinic
        • Principal Investigator:
          • Daniel Green
        • Contact:
      • Toronto, Ontario, Canada, M6A 3B4
        • Recruiting
        • Toronto Immune and Digestive Health Institute (TIDHI)
        • Principal Investigator:
          • Mark Silverberg
        • Contact:
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Not yet recruiting
        • Toronto Digestive Disease Associates
        • Contact:
        • Principal Investigator:
          • David Ford
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Not yet recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Contact:
        • Principal Investigator:
          • Robert Battat
  • Croatia
      • Osijek, Croatia, 31000
        • Not yet recruiting
        • Poliklinika Borzan d.o.o.
        • Principal Investigator:
          • Vladimir Borzan
        • Contact:
      • Rijeka, Croatia, 51000
        • Active, not recruiting
        • Clinical Hospital Center Rijeka
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • University Hospital Centre Sestre Milosrdnice
        • Contact:
        • Principal Investigator:
          • Alen Biscanin
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Not yet recruiting
        • Fakultni nemocnice Hradec Kralove
        • Principal Investigator:
          • Tomas Douda
        • Contact:
      • Hradec Králové, Czechia, 500 12
        • Not yet recruiting
        • Hepato-gastroenterologie HK, s.r.o.
        • Principal Investigator:
          • Tomas Vanasek
        • Contact:
      • Prague, Czechia, 190 00
        • Not yet recruiting
        • IBD Clinical and Research centre
        • Principal Investigator:
          • Milan Lukas
        • Contact:
      • České Budějovice, Czechia, 370 01
        • Not yet recruiting
        • Nemocnice Ceske Budejovice, a.s.
        • Principal Investigator:
          • Martin Bortlik
        • Contact:
  • Denmark
      • Aalborg, Denmark, 9000
        • Not yet recruiting
        • Aalborg Hospital
        • Principal Investigator:
          • Jan Fallingborg
        • Contact:
          • Site Contact
          • Phone Number: 97663501
          • Email: jaf@rn.dk
      • Hvidovre, Denmark, 2650
        • Not yet recruiting
        • Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
        • Contact:
        • Principal Investigator:
          • Gitte Pedersen
  • France
      • Amiens, France, 80054
        • Not yet recruiting
        • CHU d'Amiens-Picardie - Hôpital Sud
        • Principal Investigator:
          • Mathurin FUMERY
        • Contact:
      • Lille, France, 59037
        • Not yet recruiting
        • Hopital Huriez - CHRU de Lille
        • Principal Investigator:
          • Maria NACHURY
        • Contact:
      • Marseille, France, 13015
        • Not yet recruiting
        • Chu - Hopital Nord
        • Principal Investigator:
          • Melanie Serrero
        • Contact:
      • Nantes, France, 44093
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hopital Hotel Dieu
      • Pessac, France, 33600
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
      • Saint-Etienne, France, 42270
        • Not yet recruiting
        • CHU St Etienne Hopital Nord
        • Principal Investigator:
          • Xavier Roblin
        • Contact:
      • Toulouse, France, 31059
        • Active, not recruiting
        • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
      • Vandœuvre-lès-Nancy, France, 54511
        • Not yet recruiting
        • Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
        • Principal Investigator:
          • Laurent Peyrin Biroulet
        • Contact:
  • Germany
      • Berlin, Germany, 14163
        • Not yet recruiting
        • Krankenhaus Waldfriede e.V.
        • Contact:
        • Principal Investigator:
          • Carsten Buening
      • Frankfurt am Main, Germany, 60431
        • Not yet recruiting
        • Agaplesion Markus Krankenhaus
        • Principal Investigator:
          • Axel Dignass
        • Contact:
      • Halle, Germany, 06108
        • Not yet recruiting
        • Studiengesellschaft BSF
        • Principal Investigator:
          • Lars Fechner
        • Contact:
      • Jena, Germany, 07747
        • Not yet recruiting
        • Universitaetsklinikum Jena
        • Contact:
        • Principal Investigator:
          • Andreas Stallmach
      • Kiel, Germany, 24105
        • Not yet recruiting
        • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
        • Principal Investigator:
          • Stefan Schreiber
        • Contact:
      • Ludwigshafen, Germany, 67065
        • Not yet recruiting
        • St. Marien- und St. Annastiftskrankenhaus
        • Principal Investigator:
          • Tanja Kuehbacher
        • Contact:
      • Mannheim, Germany, 68167
        • Not yet recruiting
        • Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
        • Principal Investigator:
          • Wolfgang Reindl
        • Contact:
  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Not yet recruiting
        • University of Athens School of Medicine, Alexandra General Hospital
        • Contact:
        • Principal Investigator:
          • Evanthia Zampeli
      • Piraeus, Attica, Greece, 185 37
        • Not yet recruiting
        • Metaxa Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Eftychia Tsironi
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Not yet recruiting
        • University Hospital of Heraklion
        • Principal Investigator:
          • Ioannis Koutroubakis
        • Contact:
  • Hungary
      • Budapest, Hungary, 1082
      • Budapest, Hungary, 1062
        • Not yet recruiting
        • Central Hospital of Northern Pest - Military Hospital
        • Contact:
        • Principal Investigator:
          • Tibor Gyokeres
      • Szeged, Hungary, 6720
        • Not yet recruiting
        • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
        • Principal Investigator:
          • Tamas Molnar
        • Contact:
  • Ireland
      • Dublin, Ireland, 24
        • Not yet recruiting
        • Adelaide, Meath and National Children's Hospital
        • Contact:
        • Principal Investigator:
          • Sarah O'Donnell
      • Dublin, Ireland, D04 T6F4
        • Not yet recruiting
        • University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
        • Principal Investigator:
          • Glen Doherty
        • Contact:
      • Dublin, Ireland, D09 V2N0
        • Not yet recruiting
        • Beaumont Hospital
        • Principal Investigator:
          • Aoibhlinn O'Toole
        • Contact:
  • Israel
      • Beersheba, Israel, 8410101
        • Not yet recruiting
        • Soroka Medical Center
        • Contact:
        • Principal Investigator:
          • Doron Schwartz
      • Haifa, Israel, 3109601
        • Not yet recruiting
        • Rambam Health Care Campus (RHCC)
        • Principal Investigator:
          • Roni Weisshof
        • Contact:
      • Kfar Saba, Israel, 44281
        • Not yet recruiting
        • Meir Medical Center
        • Principal Investigator:
          • Michal Openhaim
        • Contact:
      • Petah Tikva, Israel, 49100
        • Not yet recruiting
        • Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
        • Principal Investigator:
          • Irit Avni-Biron
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Not yet recruiting
        • The Tel Aviv Sourasky Medical Center
        • Contact:
        • Principal Investigator:
          • Nathaniel Aviv Cohen
  • Italy
      • Milan, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
        • Principal Investigator:
          • Silvio Danese
        • Contact:
      • Naples, Italy, 80131
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Federico II di Napoli
        • Principal Investigator:
          • Fabiana Castiglione
        • Contact:
      • Roma, Italy, 00168
        • Not yet recruiting
        • A. Gemelli University Hospital, Catholic University of the Sacred Heart
        • Principal Investigator:
          • Antonio Gasbarrini
        • Contact:
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Humanitas Clinical And Research Institute
        • Principal Investigator:
          • Alessandro Armuzzi
        • Contact:
      • San Giovanni Rotondo, Italy, 71013
        • Not yet recruiting
        • Fondazione IRCSS Casa Sollievo Della Sofferenza
        • Principal Investigator:
          • Fabrizio Bossa
        • Contact:
      • Torino, Italy, 10122
        • Not yet recruiting
        • AO Ordine Mauriziano di Torino
        • Principal Investigator:
          • Marco Daperno
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Not yet recruiting
        • Amsterdam UMC Research BV
        • Principal Investigator:
          • Mark Lowenberg
        • Contact:
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Radboud University Medical Center
        • Principal Investigator:
          • Marjolijn Duijvestein
        • Contact:
      • Rotterdam, Netherlands, 3015 GD
        • Not yet recruiting
        • Erasmus Medisch Centrum
        • Contact:
        • Principal Investigator:
          • Annemarie Vries
      • Tilburg, Netherlands, 5022 GC
        • Not yet recruiting
        • Elisabeth TweeSteden Ziekenhuis (ETZ)
        • Contact:
        • Principal Investigator:
          • Maurice Lutgens
  • Norway
      • Bergen, Norway, N5021
        • Not yet recruiting
        • Haukeland Universitetssjukehus (Haukeland University Hospital)
        • Contact:
        • Principal Investigator:
          • Kim Nylund
      • Lorenskog, Norway, 1478
        • Not yet recruiting
        • Akershus University Hospital
        • Principal Investigator:
          • Stephan Brackmann
        • Contact:
      • Oslo, Norway, 0424
        • Not yet recruiting
        • Oslo Universitetssykehus HF, Ulleval
        • Contact:
        • Principal Investigator:
          • Marte Lie Hoivik
    • Gjettum
      • Drammen, Gjettum, Norway, 1309
        • Not yet recruiting
        • Vestre Viken HF - Baerum Sykehus
        • Principal Investigator:
          • Stine Astrup Hvattum
        • Contact:
  • Poland
      • Lodz, Poland, 90-153
        • Not yet recruiting
        • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
        • Principal Investigator:
          • Ewa Malecka-Wojciesko
        • Contact:
      • Poznan, Poland, 60-354
        • Not yet recruiting
        • Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
        • Principal Investigator:
          • Piotr Eder
        • Contact:
      • Tychy, Poland, 43-100
        • Not yet recruiting
        • H-T. Centrum Medyczne Sp. z o.o. Sp.k.
        • Principal Investigator:
          • Tomasz Romanczyk
        • Contact:
      • Warsaw, Poland, 05-401
        • Not yet recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
      • Warsaw, Poland, 02-507
        • Not yet recruiting
        • PANSTWOWY INSTYTUT MEDYCZNY MSWiA
        • Principal Investigator:
          • Grazyna Rydzewska-Wyszkowska
        • Contact:
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Not yet recruiting
        • Unidade Local de Saude Coimbra
        • Contact:
        • Principal Investigator:
          • Francisco Da Silva Portela
      • Lisbon, Portugal, 1349-019
        • Not yet recruiting
        • Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
        • Contact:
        • Principal Investigator:
          • Tiago Bana e Costa
      • Lisbon, Portugal, 1649-028
        • Not yet recruiting
        • Centro Hospitalar Universitario Lisboa Norte EPE
        • Contact:
        • Principal Investigator:
          • Ana Sofia Leite Pinto Saraiva Menezes
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Not yet recruiting
        • University Clinical Centre - Ljubljana
        • Principal Investigator:
          • David Drobne
        • Contact:
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Tae-Oh Kim
        • Contact:
      • Daegu, South Korea, 42415
        • Active, not recruiting
        • Yeungnam University Medical Center
      • Daejeon, South Korea, 34943
        • Active, not recruiting
        • The Catholic University of Korea, Daejeon St.Mary's Hospital
      • Seoul, South Korea, 02447
        • Recruiting
        • Kyung Hee University Hospital
        • Contact:
        • Principal Investigator:
          • Chang Kyun Lee
      • Seoul, South Korea, 03722
        • Active, not recruiting
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 06591
        • Active, not recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, South Korea, 06973
        • Active, not recruiting
        • Chung-Ang University Hospital
      • Suwon, South Korea, 16247
        • Active, not recruiting
        • The Catholic university of Korea, St. Vincent's Hospital
  • Spain
      • Madrid, Spain, 28046
        • Active, not recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Active, not recruiting
        • Hospital General Universitario Gregorio Maranon (HGUGM)
      • Palma, Spain, 07120
        • Not yet recruiting
        • Hospital Universitari Son Espases
        • Principal Investigator:
          • Daniel Ginard Vicens
        • Contact:
      • Pamplona, Spain, 31008
        • Active, not recruiting
        • Complejo Hospitalario de Navarra (CHN)
      • Santiago de Compostela, Spain, 15706
        • Not yet recruiting
        • Complejo Hospitalario Universitario de Santiago de Compostela
        • Principal Investigator:
          • Manuel Francisco Barreiro de Acosta
        • Contact:
      • Valencia, Spain, 46026
        • Not yet recruiting
        • Hospital Universitari i Politecnic La Fe
        • Contact:
        • Principal Investigator:
          • Pilar Nos Mateu
  • Sweden
      • Linköping, Sweden
        • Not yet recruiting
        • Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
        • Contact:
        • Principal Investigator:
          • Henrik Hjortswang
      • Stockholm, Sweden, 116 30
      • Stockholm, Sweden, 171 76
        • Not yet recruiting
        • Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Charlotte Hedin
      • Stockholm, Sweden, 182 88
        • Not yet recruiting
        • Danderyds Sjukhus AB
        • Principal Investigator:
          • Mikael Lordal
        • Contact:
  • Switzerland
      • Basel, Switzerland, 4031
        • Not yet recruiting
        • University Hospital Basel
        • Principal Investigator:
          • Jan Niess
        • Contact:
      • Bern, Switzerland, 3010
        • Not yet recruiting
        • University Hospital Bern (Inselspital)
        • Principal Investigator:
          • Niklas Krupka
        • Contact:
      • Zurich, Switzerland, 8091
        • Not yet recruiting
        • Universitatsspital Zurich
        • Principal Investigator:
          • Luc Biedermann
        • Contact:
      • Zurich, Switzerland, 8048
        • Not yet recruiting
        • Zentrum fur Gastroenterologie
        • Contact:
        • Principal Investigator:
          • Stephan Vavricka
  • Taiwan
      • Changhua, Taiwan, 50006
        • Not yet recruiting
        • Changhua Christian Hospital
        • Contact:
        • Principal Investigator:
          • Hsu-Heng Yen
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Chung-Hsin Chang
      • Taichung, Taiwan, 40201
        • Not yet recruiting
        • Chung Shan Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Ching-Pi Lin
      • Tainan, Taiwan, 70403
        • Not yet recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Principal Investigator:
          • Chiao-Hsiung Chuang
      • Taipei, Taiwan, 11490
        • Not yet recruiting
        • National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
        • Contact:
        • Principal Investigator:
          • Tien-Yu Huang
      • Taoyuan City, Taiwan, 33305
        • Not yet recruiting
        • Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
        • Principal Investigator:
          • Cheng-Tang Chiu
        • Contact:
  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 7EH
        • Not yet recruiting
        • St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
        • Principal Investigator:
          • Peter Irving
        • Contact:
    • Greater London
      • London, Greater London, United Kingdom, E1 1BB
        • Not yet recruiting
        • The Royal London Hospital - Barts Health NHS Trust
        • Principal Investigator:
          • Gareth Parkes
        • Contact:
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH4 2XU
        • Not yet recruiting
        • Western General Hospital
        • Contact:
        • Principal Investigator:
          • Charlie Lees
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Not yet recruiting
        • Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
        • Contact:
        • Principal Investigator:
          • Jonathan MacDonald
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Not yet recruiting
        • UCSD Medical Center
        • Contact:
        • Principal Investigator:
          • Siddharth Singh
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Keck Medicine Of USC - USC Healthcare Center 1
        • Contact:
        • Principal Investigator:
          • Sarah Sheibani
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Peak Gastroenterology Associates
        • Principal Investigator:
          • Bhaktasharan Patel
        • Contact:
    • Florida
      • Naples, Florida, United States, 34102
        • Active, not recruiting
        • GI PROS, Inc.
      • Orlando, Florida, United States, 32806
        • Active, not recruiting
        • Orlando Health Ambulatory Care Center
      • Tampa, Florida, United States, 33612
        • Active, not recruiting
        • USF Health Morsani Center For Advanced Healthcare
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University (IU) Health University Hospital
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Active, not recruiting
        • University Of Kentucky
    • New York
      • New York, New York, United States, 10029-5204
        • Active, not recruiting
        • Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center, New York-Presbyterian Hospital
        • Principal Investigator:
          • Bo Shen
        • Contact:
      • New York, New York, United States, 10075
        • Active, not recruiting
        • Lenox Hill Hospital Northwell Health
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Active, not recruiting
        • Gastroenterology Associates
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Active, not recruiting
        • Rapid City Medical Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Southern Star Research Institute, LLC
        • Principal Investigator:
          • Jeff Bullock
        • Contact:
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Tyler Research Institute, LLC
        • Principal Investigator:
          • George DuVall
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Not yet recruiting
        • Swedish Cancer Institute
        • Principal Investigator:
          • Michael Chiorean
        • Contact:
      • Seattle, Washington, United States, 98101
        • Active, not recruiting
        • Virginia Mason Medical Center
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
        • Principal Investigator:
          • Scott Lee
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Medical College of Wisconsin Cancer Center - Froedtert Hospital
        • Contact:
        • Principal Investigator:
          • Poonam Beniwal-Patel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
  3. 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.
  4. The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.

Exclusion Criteria:

  1. The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
  2. 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.
  3. 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.
  4. The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
  5. 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.
  6. The participant has an ostomy or ileoanal pouch.
  7. 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).
  8. The participant has severe (Child-Pugh C) hepatic impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Double-blind Induction Phase: Vedolizumab + Upadacitinib
Participants 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.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • Entyvio
  • MLN0002
  • KYNTELES
Drug: Upadacitinib
Upadacitinib over-encapsulated tablets.
Other Names:
  • Rinvoq
Placebo Comparator: Double-blind Induction Phase: Vedolizumab + Placebo
Participants will receive vedolizumab IV 300 mg infusion, at Weeks 0, 2, 6 and 10 along with upadacitinib matched placebo, orally, QD for 12 weeks.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • Entyvio
  • MLN0002
  • KYNTELES
Drug: Placebo
Upadacitinib matched placebo capsules.
Experimental: Main Study Maintenance Phase: Vedolizumab Monotherapy
Participants 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.
Drug: Vedolizumab
Vedolizumab IV infusion.
Other Names:
  • Entyvio
  • MLN0002
  • KYNTELES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12
Time Frame: 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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 52
Time Frame: 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.
Week 52
Percentage of Participants Achieving 2-item PRO2 Based Clinical Remission at Week 52
Time Frame: 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.
Week 52
Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Based Clinical Remission at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 12
Time Frame: 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.
Week 12
Percentage of Participants Exhibiting an Endoscopic Response Based on SES-CD at Week 52
Time Frame: 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.
Week 52
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 52
Time Frame: 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.
Week 52
Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 52
Time Frame: 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
Week 52
Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 52
Time Frame: 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.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Estimated)

June 8, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vedolizumab-3043
  • 2023-509391-42-00 (Ctis: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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