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A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Sponsor: Takeda
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
396
Start Date
2025-01-02
Completion Date
2028-08-01
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
Vedolizumab
Vedolizumab IV infusion.
Upadacitinib
Upadacitinib over-encapsulated tablets.
Placebo
Upadacitinib matched placebo capsules.
Locations (138)
UCSD Medical Center
La Jolla, California, United States
Keck Medicine Of USC - USC Healthcare Center 1
Los Angeles, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
GI PROS, Inc.
Naples, Florida, United States
Orlando Health Ambulatory Care Center
Orlando, Florida, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States
Indiana University (IU) Health University Hospital
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
New York, New York, United States
Columbia University Medical Center, New York-Presbyterian Hospital
New York, New York, United States
Lenox Hill Hospital Northwell Health
New York, New York, United States
Gastroenterology Associates
Greenville, South Carolina, United States
Rapid City Medical Center
Rapid City, South Dakota, United States
Southern Star Research Institute, LLC
San Antonio, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Swedish Cancer Institute
Seattle, Washington, United States
University of Washington Medical Center - Montlake
Seattle, Washington, United States
Medical College of Wisconsin Cancer Center - Froedtert Hospital
Milwaukee, Wisconsin, United States
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, State of Vienna, Austria
Medical University Innsbruck
Innsbruck, Tyrol, Austria
Johannes Kepler Universitat Linz (JKU)
Linz, Austria
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
Salzburg, Austria
Krankenhaus der Barmherzigen Brueder Wien
Vienna, Austria
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht, Belgium
Imelda GI Clinical Research Center
Bonheiden, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
University Hospitals Leuven
Leuven, Belgium
Centre Hospitalier Chretien MontLegia
Liège, Belgium
Hospital Universitario Cajuru
Curitiba, Paraná, Brazil
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Centro de Estudos Clinico do Interior Paulista - CECIP
Jaú, São Paulo, Brazil
Pesquisare Saude
Santo André, São Paulo, Brazil
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, Brazil
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, Brazil
Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
São Paulo, Brazil
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
Winnipeg, Manitoba, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
Hamilton, Ontario, Canada
Taunton Surgical Centre-Oshawa Clinic
Oshawa, Ontario, Canada
Toronto Immune and Digestive Health Institute (TIDHI)
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Poliklinika Borzan d.o.o.
Osijek, Croatia
Clinical Hospital Center Rijeka
Rijeka, Croatia
University Hospital Centre Sestre Milosrdnice
Zagreb, Croatia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia
IBD Clinical and Research centre
Prague, Czechia
Aalborg Hospital
Aalborg, Denmark
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, Denmark
CHU d'Amiens-Picardie - Hopital SUD
Amiens, France
Hopital Huriez - CHRU de Lille
Lille, France
Chu - Hopital Nord
Marseille, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, France
CHU St Etienne Hopital Nord
Saint-Etienne, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
Toulouse, France
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
Vandœuvre-lès-Nancy, France
Krankenhaus Waldfriede e.V.
Berlin, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, Germany
Studiengesellschaft BSF
Halle, Germany
Universitaetsklinikum Jena
Jena, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, Germany
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, Germany
Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
Mannheim, Germany
University of Athens School of Medicine, Alexandra General Hospital
Athens, Attica, Greece
Metaxa Cancer Hospital
Piraeus, Attica, Greece
University Hospital of Heraklion
Heraklion, Crete, Greece
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary
Semmelweis Egyetem
Budapest, Hungary
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
Szeged, Hungary
Adelaide, Meath and National Children's Hospital
Dublin, Ireland
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
Dublin, Ireland
Beaumont Hospital
Dublin, Ireland
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Campus (RHCC)
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petah Tikva, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
Milan, Italy
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, Italy
Humanitas Clinical And Research Institute
Rozzano, Italy
Fondazione IRCSS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
AO Ordine Mauriziano di Torino
Torino, Italy
Amsterdam UMC Research BV
Amsterdam, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Elisabeth TweeSteden Ziekenhuis (ETZ)
Tilburg, Netherlands
Vestre Viken HF - Baerum Sykehus
Drammen, Gjettum, Norway
Haukeland Universitetssjukehus (Haukeland University Hospital)
Bergen, Norway
Akershus University Hospital
Lorenskog, Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, Norway
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland
Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
Poznan, Poland
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, Poland