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

Last updated: May 8, 2025
Sponsor: Takeda
Overall Status: Active - Recruiting

Phase

3

Condition

Crohn's Disease

Colic

Ulcerative Colitis

Treatment

Placebo

Vedolizumab

Upadacitinib

Clinical Study ID

NCT06227910
Vedolizumab-3043
2023-509391-42
  • Ages 18-65
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The participant has a diagnosis of CD established at least 3 months before screeningby clinical and endoscopic evidence and corroborated by a histopathology report.

  2. The participant has a confirmed diagnosis of moderately to severely active CD asassessed by CDAI of 220-450.

  3. The participant has evidence of mucosal inflammation based on the SES-CD: SES-CDscore (excluding the presence of narrowing component) of >=6 (or >=4 forparticipants with isolated ileal disease), as confirmed by a central reader.

  4. The participant has demonstrated an inadequate response to, loss of response to, orintolerance to corticosteroids, immunomodulators, or biologic therapy.

Exclusion

Exclusion Criteria:

  1. The participant has a current diagnosis of ulcerative colitis or indeterminatecolitis.

  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 priorto baseline.

  3. The participant has evidence of an active infection during the screening period, orclinically significant infection within 30 days prior to screening, or ongoingchronic infection.

  4. The participant has a history of recurrent or disseminated (including a singleepisode) 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 ofthe following 5 segments: terminal ileum, right colon, transverse colon, sigmoid andleft colon, and rectum; fulminant colitis; toxic megacolon; or any othermanifestation 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 glomerularfiltration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).

  8. The participant has severe (Child-Pugh C) hepatic impairment.

Study Design

Total Participants: 396
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 02, 2025
Estimated Completion Date:
August 01, 2028

Study 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.

Connect with a study center

  • Medical University Innsbruck

    Innsbruck, Tyrol 6020
    Austria

    Site Not Available

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

    Wien, Vienna 1090
    Austria

    Site Not Available

  • Johannes Kepler Universitat Linz (JKU)

    Linz, 4021
    Austria

    Site Not Available

  • Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss

    Salzburg, 5020
    Austria

    Site Not Available

  • Krankenhaus der Barmherzigen Brueder Wien

    Wien, 1020
    Austria

    Site Not Available

  • Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel

    Brussel, Anderlecht 1070
    Belgium

    Site Not Available

  • Imelda GI Clinical Research Center

    Bonheiden, 2820
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • University Hospitals Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Centre Hospitalier Chretien MontLegia

    Liege, 4000
    Belgium

    Site Not Available

  • Hospital Universitario Cajuru

    Curitiba, Parana 80050-350
    Brazil

    Site Not Available

  • Faculdade de Medicina de Botucatu

    Botucatu, Sao Paulo 18618-970
    Brazil

    Site Not Available

  • Centro de Estudos Clinico do Interior Paulista - CECIP

    Jau, Sao Paulo 17201130
    Brazil

    Site Not Available

  • Pesquisare Saude

    Santo Andre, Sao Paulo 9080110
    Brazil

    Site Not Available

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

    Rio De Janeiro, 21941-617
    Brazil

    Site Not Available

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

    Sao Paulo, 05403-010
    Brazil

    Site Not Available

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

    Sao Paulo, 1405-1243
    Brazil

    Site Not Available

  • Heritage Medical Research Clinic - University Of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

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

    Winnipeg, Manitoba R3A 1R9
    Canada

    Site Not Available

  • Dalhousie University

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Barrie GI Associates

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

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

    Hamilton, Ontario L8S 4K1
    Canada

    Site Not Available

  • Toronto Immune and Digestive Health Institute (TIDHI)

    North York, Ontario M6A 3B4
    Canada

    Site Not Available

  • Taunton Surgical Centre-Oshawa Clinic

    Oshawa, Ontario L1J 0C7
    Canada

    Active - Recruiting

  • Toronto Immune and Digestive Health Institute (TIDHI)

    Toronto, Ontario M6A 3B4
    Canada

    Active - Recruiting

  • Toronto Digestive Disease Associates

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • Poliklinika Borzan d.o.o.

    Osijek, 31000
    Croatia

    Site Not Available

  • Clinical Hospital Center Rijeka

    Rijeka, 51000
    Croatia

    Site Not Available

  • University Hospital Centre Sestre Milosrdnice

    Zagreb, 10000
    Croatia

    Site Not Available

  • Nemocnice Ceske Budejovice, a.s.

    Ceske Budejovice, 370 01
    Czechia

    Site Not Available

  • Fakultni Nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

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

    Hradec Kralove, 500 12
    Czechia

    Site Not Available

  • IBD Clinical and Research centre

    Prague, 190 00
    Czechia

    Site Not Available

  • Aalborg Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling

    Hvidovre, 2650
    Denmark

    Site Not Available

  • CHU d'Amiens-Picardie - Hopital SUD

    Amiens Cedex 01, 80054
    France

    Site Not Available

  • Hopital Huriez - CHRU de Lille

    Lille Cedex, 59037
    France

    Site Not Available

  • Chu - Hopital Nord

    Marseille Cedex 20, 13015
    France

    Site Not Available

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

    Nantes, 44093
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque

    Pessac, 33600
    France

    Site Not Available

  • CHU St Etienne Hopital Nord

    Saint Etienne, 42270
    France

    Site Not Available

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

    Toulouse cedex 09, 31059
    France

    Site Not Available

  • Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois

    Vandoeuvre les Nancy, 54511
    France

    Site Not Available

  • Krankenhaus Waldfriede e.V.

    Berlin, 14163
    Germany

    Site Not Available

  • Agaplesion Markus Krankenhaus

    Frankfurt Am Main, 60431
    Germany

    Site Not Available

  • Studiengesellschaft BSF

    Halle, 06108
    Germany

    Site Not Available

  • Universitaetsklinikum Jena

    Jena, 07747
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • St. Marien- und St. Annastiftskrankenhaus

    Ludwigshafen, 67065
    Germany

    Site Not Available

  • Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik

    Mannheim, 68167
    Germany

    Site Not Available

  • University of Athens School of Medicine, Alexandra General Hospital

    Athens, Attiki 11528
    Greece

    Site Not Available

  • Metaxa Cancer Hospital

    Piraeus, Attiki 185 37
    Greece

    Site Not Available

  • University Hospital of Heraklion

    Heraklion, Crete 71110
    Greece

    Site Not Available

  • Central Hospital of Northern Pest - Military Hospital

    Budapest, 1062
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1082
    Hungary

    Site Not Available

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika

    Szeged, 6720
    Hungary

    Site Not Available

  • Adelaide, Meath and National Children's Hospital

    Dublin, 24
    Ireland

    Site Not Available

  • Beaumont Hospital

    Dublin, D09 V2N0
    Ireland

    Site Not Available

  • University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)

    Dublin, D04 T6F4
    Ireland

    Site Not Available

  • Soroka Medical Center

    Be'er Sheva, 8410101
    Israel

    Site Not Available

  • Rambam Health Care Campus (RHCC)

    Haifa, 3109601
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar-Saba, 44281
    Israel

    Site Not Available

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

    Petach Tikva, 49100
    Israel

    Site Not Available

  • The Tel Aviv Sourasky Medical Center

    Tel-Aviv, 6423906
    Israel

    Site Not Available

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

    Milano, 20132
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Federico II di Napoli

    Naples, 80131
    Italy

    Site Not Available

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

    Roma, 00168
    Italy

    Site Not Available

  • Humanitas Clinical And Research Institute

    Rozzano, 20089
    Italy

    Site Not Available

  • Fondazione IRCSS Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • AO Ordine Mauriziano di Torino

    Torino, 10122
    Italy

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Medical Center

    Daegu, 42415
    Korea, Republic of

    Site Not Available

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

    Daejeon, 34943
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul, 06973
    Korea, Republic of

    Site Not Available

  • Kyung Hee University Hospital

    Seoul, 02447
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

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

    Seoul, 06591
    Korea, Republic of

    Site Not Available

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

    Suwon-si, 16247
    Korea, Republic of

    Site Not Available

  • Amsterdam UMC Research BV

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Radboud University Medical Center

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Elisabeth TweeSteden Ziekenhuis (ETZ)

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • Vestre Viken HF - Baerum Sykehus

    Drammen, Gjettum 1309
    Norway

    Site Not Available

  • Haukeland Universitetssjukehus (Haukeland University Hospital)

    Bergen, N5021
    Norway

    Site Not Available

  • Akershus University Hospital

    Lorenskog, 1478
    Norway

    Site Not Available

  • Oslo Universitetssykehus HF, Ulleval

    Oslo, 0424
    Norway

    Site Not Available

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

    Lodz, 90-153
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um

    Poznan, 60-354
    Poland

    Site Not Available

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

    Tychy, 43-100
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 05-401
    Poland

    Site Not Available

  • Panstwowy Instytut Medyczny MSWiA

    Warszawa, 02-507
    Poland

    Site Not Available

  • Unidade Local de Saude Coimbra

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Centro Hospitalar Universitario Lisboa Norte EPE

    Lisboa, 1649-028
    Portugal

    Site Not Available

  • Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz

    Lisbon, 1349-019
    Portugal

    Site Not Available

  • University Clinical Centre - Ljubljana

    Ljubljana, 1000
    Slovenia

    Site Not Available

  • Hospital General Universitario Gregorio Maranon (HGUGM)

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitari Son Espases

    Palma, 07120
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra (CHN)

    Pamplona, 31008
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario De Santiago De Compostela

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026
    Spain

    Site Not Available

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

    Linkoping,
    Sweden

    Site Not Available

  • Danderyds Sjukhus AB

    Stockholm, 182 88
    Sweden

    Site Not Available

  • Ersta sjukhus

    Stockholm, 116 30
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital

    Stockholm, 171 76
    Sweden

    Site Not Available

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • University Hospital Bern (Inselspital)

    Bern, 3010
    Switzerland

    Site Not Available

  • Universitatsspital Zurich

    Zurich, 8091
    Switzerland

    Site Not Available

  • Zentrum fur Gastroenterologie

    Zurich, 8048
    Switzerland

    Site Not Available

  • Changhua Christian Hospital

    Changhua City, 50006
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70403
    Taiwan

    Site Not Available

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

    Taipei, 11490
    Taiwan

    Site Not Available

  • Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33305
    Taiwan

    Site Not Available

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

    London, England SE1 7EH
    United Kingdom

    Site Not Available

  • The Royal London Hospital - Barts Health NHS Trust

    London, Greater London E1 1BB
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, Lothian EH4 2XU
    United Kingdom

    Site Not Available

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

    Glasgow, Scotland G51 4TF
    United Kingdom

    Site Not Available

  • UCSD Medical Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Keck Medicine Of USC - USC Healthcare Center 1

    Los Angeles, California 90033
    United States

    Site Not Available

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • GI PROS Research

    Naples, Florida 34102
    United States

    Active - Recruiting

  • GI PROS, Inc.

    Naples, Florida 34102
    United States

    Site Not Available

  • Orlando Health Ambulatory Care Center

    Orlando, Florida 32806
    United States

    Site Not Available

  • USF Health Morsani Center for Advanced Healthcare

    Tampa, Florida 33612
    United States

    Site Not Available

  • Indiana University (IU) Health University Hospital

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Columbia University Medical Center, New York-Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • Lenox Hill Hospital Northwell Health

    New York, New York 10075
    United States

    Site Not Available

  • Lenox Hill Hospital-Northwell Health

    New York, New York 10075
    United States

    Active - Recruiting

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

    New York, New York 10029-5204
    United States

    Site Not Available

  • Gastroenterology Associates

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Rapid City Medical Center

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Southern Star Research Institute

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Southern Star Research Institute, LLC

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • University of Washington Medical Center - Montlake

    Seattle, Washington 98195
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Medical College of Wisconsin Cancer Center - Froedtert Hospital

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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