A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
NCT ID: NCT06227910
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
396 participants
INTERVENTIONAL
2025-01-02
2028-08-01
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
Vedolizumab
Vedolizumab IV infusion.
Upadacitinib
Upadacitinib over-encapsulated tablets.
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.
Vedolizumab
Vedolizumab IV infusion.
Placebo
Upadacitinib matched placebo capsules.
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.
Vedolizumab
Vedolizumab IV infusion.
Interventions
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Vedolizumab
Vedolizumab IV infusion.
Upadacitinib
Upadacitinib over-encapsulated tablets.
Placebo
Upadacitinib matched placebo capsules.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 (excluding the presence of narrowing component) 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
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.
18 Years
65 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Medical University Innsbruck
Innsbruck, Tyrol, Austria
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, Vienna, 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
Panstwowy Instytut Medyczny MSWiA
Warsaw, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Unidade Local de Saude Coimbra
Coimbra, , Portugal
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
Lisbon, , Portugal
Centro Hospitalar Universitario Lisboa Norte EPE
Lisbon, , Portugal
University Clinical Centre - Ljubljana
Ljubljana, , Slovenia
Inje University Haeundae Paik Hospital
Busan, , South Korea
Yeungnam University Medical Center
Daegu, , South Korea
The Catholic University of Korea, Daejeon St.Mary's Hospital
Daejeon, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, , South Korea
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitari Son Espases
Palma, , Spain
Complejo Hospitalario de Navarra (CHN)
Pamplona, , Spain
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Universitari I Politecnic La Fe
Valencia, , Spain
Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
Linköping, , Sweden
Ersta sjukhus
Stockholm, , Sweden
Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
Stockholm, , Sweden
Danderyds Sjukhus AB
Stockholm, , Sweden
University Hospital Basel
Basel, , Switzerland
University Hospital Bern (Inselspital)
Bern, , Switzerland
Zentrum fur Gastroenterologie
Zurich, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Changhua Christian Hospital
Changhua, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
Taipei, , Taiwan
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, England, United Kingdom
The Royal London Hospital - Barts Health NHS Trust
London, Greater London, United Kingdom
Western General Hospital
Edinburgh, Lothian, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
Glasgow, Scotland, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Other Identifiers
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2023-509391-42-00
Identifier Type: CTIS
Identifier Source: secondary_id
Vedolizumab-3043
Identifier Type: -
Identifier Source: org_study_id
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