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
Status: Recruiting
Location: See all (134) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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 (excluding the presence of narrowing component) 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.
Locations
United States
California
UCSD Medical Center
NOT_YET_RECRUITING
La Jolla
Keck Medicine Of USC - USC Healthcare Center 1
NOT_YET_RECRUITING
Los Angeles
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
GI PROS, Inc.
ACTIVE_NOT_RECRUITING
Naples
Orlando Health Ambulatory Care Center
ACTIVE_NOT_RECRUITING
Orlando
USF Health Morsani Center for Advanced Healthcare
ACTIVE_NOT_RECRUITING
Tampa
Indiana
Indiana University (IU) Health University Hospital
ACTIVE_NOT_RECRUITING
Indianapolis
Kentucky
University of Kentucky
ACTIVE_NOT_RECRUITING
Lexington
New York
Columbia University Medical Center, New York-Presbyterian Hospital
NOT_YET_RECRUITING
New York
Lenox Hill Hospital Northwell Health
ACTIVE_NOT_RECRUITING
New York
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
ACTIVE_NOT_RECRUITING
New York
South Carolina
Gastroenterology Associates
ACTIVE_NOT_RECRUITING
Greenville
South Dakota
Rapid City Medical Center
ACTIVE_NOT_RECRUITING
Rapid City
Texas
Southern Star Research Institute, LLC
RECRUITING
San Antonio
Tyler Research Institute, LLC
RECRUITING
Tyler
Washington
Swedish Cancer Institute
NOT_YET_RECRUITING
Seattle
University of Washington Medical Center - Montlake
NOT_YET_RECRUITING
Seattle
Virginia Mason Medical Center
ACTIVE_NOT_RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin Cancer Center - Froedtert Hospital
NOT_YET_RECRUITING
Milwaukee
Other Locations
Austria
Medical University Innsbruck
NOT_YET_RECRUITING
Innsbruck
Johannes Kepler Universitat Linz (JKU)
NOT_YET_RECRUITING
Linz
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
NOT_YET_RECRUITING
Salzburg
Krankenhaus der Barmherzigen Brueder Wien
NOT_YET_RECRUITING
Vienna
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
NOT_YET_RECRUITING
Vienna
Belgium
Imelda GI Clinical Research Center
ACTIVE_NOT_RECRUITING
Bonheiden
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
NOT_YET_RECRUITING
Brussels
Universitair Ziekenhuis Gent
NOT_YET_RECRUITING
Ghent
University Hospitals Leuven
NOT_YET_RECRUITING
Leuven
Centre Hospitalier Chretien MontLegia
NOT_YET_RECRUITING
Liège
Brazil
Faculdade de Medicina de Botucatu
NOT_YET_RECRUITING
Botucatu
Hospital Universitario Cajuru
NOT_YET_RECRUITING
Curitiba
Centro de Estudos Clinico do Interior Paulista - CECIP
NOT_YET_RECRUITING
Jaú
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
NOT_YET_RECRUITING
Rio De Janeiro
Pesquisare Saude
NOT_YET_RECRUITING
Santo André
Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC/FMUSP))
NOT_YET_RECRUITING
São Paulo
Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
NOT_YET_RECRUITING
São Paulo
Canada
Barrie GI Associates
RECRUITING
Barrie
Heritage Medical Research Clinic - University Of Calgary
ACTIVE_NOT_RECRUITING
Calgary
Dalhousie University
NOT_YET_RECRUITING
Halifax
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
ACTIVE_NOT_RECRUITING
Hamilton
Centre Hospitalier de l'Universite de Montreal
NOT_YET_RECRUITING
Montreal
Taunton Surgical Centre-Oshawa Clinic
RECRUITING
Oshawa
Toronto Immune and Digestive Health Institute (TIDHI)
RECRUITING
Toronto
Toronto Digestive Disease Associates
NOT_YET_RECRUITING
Vaughan
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
NOT_YET_RECRUITING
Winnipeg
Croatia
Poliklinika Borzan d.o.o.
NOT_YET_RECRUITING
Osijek
Clinical Hospital Center Rijeka
ACTIVE_NOT_RECRUITING
Rijeka
University Hospital Centre Sestre Milosrdnice
NOT_YET_RECRUITING
Zagreb
Denmark
Aalborg Hospital
NOT_YET_RECRUITING
Aalborg
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
NOT_YET_RECRUITING
Hvidovre
France
CHU d'Amiens-Picardie - Hopital SUD
NOT_YET_RECRUITING
Amiens
Hopital Huriez - CHRU de Lille
NOT_YET_RECRUITING
Lille
Chu - Hopital Nord
NOT_YET_RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
ACTIVE_NOT_RECRUITING
Nantes
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
ACTIVE_NOT_RECRUITING
Pessac
CHU St Etienne Hopital Nord
NOT_YET_RECRUITING
Saint-etienne
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
ACTIVE_NOT_RECRUITING
Toulouse
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Germany
Krankenhaus Waldfriede e.V.
NOT_YET_RECRUITING
Berlin
Agaplesion Markus Krankenhaus
NOT_YET_RECRUITING
Frankfurt Am Main
Studiengesellschaft BSF
NOT_YET_RECRUITING
Halle
Universitaetsklinikum Jena
NOT_YET_RECRUITING
Jena
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
NOT_YET_RECRUITING
Kiel
St. Marien- und St. Annastiftskrankenhaus
NOT_YET_RECRUITING
Ludwigshafen
Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
NOT_YET_RECRUITING
Mannheim
Greece
University of Athens School of Medicine, Alexandra General Hospital
NOT_YET_RECRUITING
Athens
University Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion
Metaxa Cancer Hospital
NOT_YET_RECRUITING
Piraeus
Hungary
Central Hospital of Northern Pest - Military Hospital
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
NOT_YET_RECRUITING
Budapest
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
NOT_YET_RECRUITING
Szeged
Ireland
Adelaide, Meath and National Children's Hospital
NOT_YET_RECRUITING
Dublin
Beaumont Hospital
NOT_YET_RECRUITING
Dublin
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
NOT_YET_RECRUITING
Dublin
Israel
Soroka Medical Center
NOT_YET_RECRUITING
Beersheba
Rambam Health Care Campus (RHCC)
NOT_YET_RECRUITING
Haifa
Meir Medical Center
NOT_YET_RECRUITING
Kfar Saba
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
NOT_YET_RECRUITING
Petah Tikva
The Tel Aviv Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero Universitaria Federico II di Napoli
NOT_YET_RECRUITING
Naples
A. Gemelli University Hospital, Catholic University of the Sacred Heart
NOT_YET_RECRUITING
Roma
Humanitas Clinical And Research Institute
NOT_YET_RECRUITING
Rozzano
Fondazione IRCSS Casa Sollievo Della Sofferenza
NOT_YET_RECRUITING
San Giovanni Rotondo
AO Ordine Mauriziano di Torino
NOT_YET_RECRUITING
Torino
Netherlands
Amsterdam UMC Research BV
NOT_YET_RECRUITING
Amsterdam
Radboud University Medical Center
NOT_YET_RECRUITING
Nijmegen
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Elisabeth TweeSteden Ziekenhuis (ETZ)
NOT_YET_RECRUITING
Tilburg
Norway
Haukeland Universitetssjukehus (Haukeland University Hospital)
NOT_YET_RECRUITING
Bergen
Vestre Viken HF - Baerum Sykehus
NOT_YET_RECRUITING
Drammen
Akershus University Hospital
NOT_YET_RECRUITING
Lorenskog
Oslo Universitetssykehus HF, Ulleval
NOT_YET_RECRUITING
Oslo
Poland
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
NOT_YET_RECRUITING
Lodz
Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
NOT_YET_RECRUITING
Poznan
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
NOT_YET_RECRUITING
Tychy
Panstwowy Instytut Medyczny MSWiA
NOT_YET_RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
NOT_YET_RECRUITING
Warsaw
Portugal
Unidade Local de Saude Coimbra
NOT_YET_RECRUITING
Coimbra
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
NOT_YET_RECRUITING
Lisbon
Centro Hospitalar Universitario Lisboa Norte EPE
NOT_YET_RECRUITING
Lisbon
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Yeungnam University Medical Center
ACTIVE_NOT_RECRUITING
Daegu
The Catholic University of Korea, Daejeon St.Mary's Hospital
ACTIVE_NOT_RECRUITING
Daejeon
Chung-Ang University Hospital
ACTIVE_NOT_RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
ACTIVE_NOT_RECRUITING
Seoul
The Catholic University Of Korea, St. Vincent's Hospital
ACTIVE_NOT_RECRUITING
Suwon
Slovenia
University Clinical Centre - Ljubljana
NOT_YET_RECRUITING
Ljubljana
Spain
Hospital General Universitario Gregorio Maranon (HGUGM)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitari Son Espases
NOT_YET_RECRUITING
Palma
Complejo Hospitalario de Navarra (CHN)
ACTIVE_NOT_RECRUITING
Pamplona
Complejo Hospitalario Universitario De Santiago De Compostela
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitari I Politecnic La Fe
NOT_YET_RECRUITING
Valencia
Sweden
Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
NOT_YET_RECRUITING
Linköping
Danderyds Sjukhus AB
NOT_YET_RECRUITING
Stockholm
Ersta sjukhus
NOT_YET_RECRUITING
Stockholm
Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Switzerland
University Hospital Basel
NOT_YET_RECRUITING
Basel
University Hospital Bern (Inselspital)
NOT_YET_RECRUITING
Bern
Universitatsspital Zurich
NOT_YET_RECRUITING
Zurich
Zentrum fur Gastroenterologie
NOT_YET_RECRUITING
Zurich
Taiwan
Changhua Christian Hospital
NOT_YET_RECRUITING
Changhua
Chung Shan Medical University Hospital
NOT_YET_RECRUITING
Taichung
Taichung Veterans General Hospital
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital
NOT_YET_RECRUITING
Tainan City
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
NOT_YET_RECRUITING
Taipei
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
NOT_YET_RECRUITING
Taoyuan
United Kingdom
Western General Hospital
NOT_YET_RECRUITING
Edinburgh
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
NOT_YET_RECRUITING
Glasgow
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING
London
The Royal London Hospital - Barts Health NHS Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-01-02
Estimated Completion Date: 2028-08-01
Participants
Target number of participants: 396
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Takeda