NCT06227910RecruitingPhase 3
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
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
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 396 (estimated)
- First submitted
- 19 Jan 2024
- Start date
- 2 Jan 2025
- Primary completion date
- 8 Jun 2027
- Lead sponsor
- Takeda
- Diseases
- Crohn's disease
- NCT number
- NCT06227910
- EU CT number
- 2023-509391-42-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 396
- From 2 Jan 2025 to the primary completion date, 8 Jun 2027
- 153 sites in 26 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
Other illness
- The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
- 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).
- The participant has severe (Child-Pugh C) hepatic impairment.
Other
- The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
- The participant has an ostomy or ileoanal pouch.
Who the study is looking for
- 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 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (153)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Kepler Universitaetsklinikum GmbH Coordinator of this site? Confirm its status | Linz | Austria | Not yet recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Not yet recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Krankenhaus Der Barmherzigen Brueder Wien Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| CHC MontLégia Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Faculdade de Medicina de Botucatu Coordinator of this site? Confirm its status | Botucatu | Brazil | Not yet recruiting |
| Hospital Universitario Cajuru Coordinator of this site? Confirm its status | Curitiba | Brazil | Not yet recruiting |
| Centro de Estudos Clinico do Interior Paulista - CECIP Coordinator of this site? Confirm its status | Jaú | Brazil | Not yet recruiting |
| Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Not yet recruiting |
| Pesquisare Saude Coordinator of this site? Confirm its status | Santo André | Brazil | Not yet recruiting |
| Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | 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)) Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Barrie GI Associates Coordinator of this site? Confirm its status | Barrie | Canada | Recruiting |
| Heritage Medical Research Clinic - University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Active, not recruiting |
| Dalhousie University Coordinator of this site? Confirm its status | Halifax | Canada | Not yet recruiting |
| McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI) Coordinator of this site? Confirm its status | Hamilton | Canada | Active, not recruiting |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| Taunton Surgical Centre-Oshawa Clinic Coordinator of this site? Confirm its status | Oshawa | Canada | Recruiting |
| Toronto Immune and Digestive Health Institute (TIDHI) Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Toronto Digestive Disease Associates Coordinator of this site? Confirm its status | Vaughan | Canada | Not yet recruiting |
| University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre Coordinator of this site? Confirm its status | Winnipeg | Canada | Not yet recruiting |
| University Hospital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Not yet recruiting |
| University Hospital Bern / Inselspital Coordinator of this site? Confirm its status | Bern | Switzerland | Not yet recruiting |
| Zentrum fur Gastroenterologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Not yet recruiting |
| Nemocnice České Budějovice, a.s. Coordinator of this site? Confirm its status | České Budějovice | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| Hepato-Gastroenterologie HK, s.r.o. Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| ISCARE a.s. Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Krankenhaus Waldfriede e.V. Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Agaplesion Frankfurter Diakonie Kliniken gGmbH Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Studiengesellschaft BSF UG (haftungsbeschraenkt) Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Recruiting |
| St. Marien und St. Annastiftskrankenhaus Coordinator of this site? Confirm its status | Ludwigshafen am Rhein | Germany | Recruiting |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Region Nordjylland Coordinator of this site? Confirm its status | Gistrup | Denmark | Recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHRU De Nancy Coordinator of this site? Confirm its status | Nancy Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Not yet recruiting |
| Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Not yet recruiting |
| The Royal London Hospital - Barts Health Nhs Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
| Alexandra Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| Metaxa Cancer Center Hospital Of Piraeus Coordinator of this site? Confirm its status | Pireas | Greece | Recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Klinicki bolnicki centar Sestre milosrdnice Coordinator of this site? Confirm its status | Grad Zagreb | Croatia | Recruiting |
| Poliklinika Borzan d.o.o. Coordinator of this site? Confirm its status | Osijek | Croatia | Recruiting |
| Clinical Hospital Centre Rijeka Coordinator of this site? Confirm its status | Rijeka | Croatia | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Central Hospital Of Northern Pest Military Hospital Coordinator of this site? Confirm its status | Budapest VI | Hungary | Recruiting |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Tallaght University Hospital Coordinator of this site? Confirm its status | Dublin 24 | Ireland | Recruiting |
| St Vincent's University Hospital Coordinator of this site? Confirm its status | Dublin 4 | Ireland | Recruiting |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Recruiting |
| University Hospital Galway Coordinator of this site? Confirm its status | Galway | Ireland | Recruiting |
| Soroka Medical Center Coordinator of this site? Confirm its status | Beersheba | Israel | Not yet recruiting |
| Rambam Health Care Campus (RHCC) Coordinator of this site? Confirm its status | Haifa | Israel | Not yet recruiting |
| Meir Medical Center Coordinator of this site? Confirm its status | Kfar Saba | Israel | Not yet recruiting |
| Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital) Coordinator of this site? Confirm its status | Petah Tikva | Israel | Not yet recruiting |
| The Tel Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Not yet recruiting |
| Azienda Ospedaliero - Universitaria di Cagliari Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Di Napoli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Active, not recruiting |
| The Catholic University of Korea, Daejeon ST.Mary's Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Active, not recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Active, not recruiting |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Active, not recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Not yet recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Not yet recruiting |
| Academisch Ziekenhuis Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Not yet recruiting |
| Radboud universitair medisch centrum Stichting Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Not yet recruiting |
| Stichting Elisabeth-TweeSteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Not yet recruiting |
| Helse Bergen HF Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Vestre Viken HF Coordinator of this site? Confirm its status | Gjettum | Norway | Recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Lorenskog | Norway | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Not yet recruiting |
| Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| H-T. Centrum Medyczne Sp. z o.o. Sp.k. Coordinator of this site? Confirm its status | Tychy | Poland | Not yet recruiting |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Klinika Reuma Park Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Loures-Odivelas EPE Coordinator of this site? Confirm its status | Loures | Portugal | Recruiting |
| Unidade Local de Saude do Algarve E.P.E. Coordinator of this site? Confirm its status | Portimao | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| Danderyds Sjukhus AB Coordinator of this site? Confirm its status | Danderyd | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Ersta Sjukhus-Ersta Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
| University Medical Center Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Not yet recruiting |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Not yet recruiting |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Not yet recruiting |
| National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu Coordinator of this site? Confirm its status | Taipei | Taiwan | Not yet recruiting |
| Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Not yet recruiting |
| Peak Gastroenterology Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Gastroenterology Associates Coordinator of this site? Confirm its status | Greenville | United States | Active, not recruiting |
| Indiana University (IU) Health University Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Active, not recruiting |
| UCSD Medical Center Coordinator of this site? Confirm its status | La Jolla | United States | Not yet recruiting |
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Active, not recruiting |
| Keck Medicine Of USC - USC Healthcare Center 1 Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Medical College of Wisconsin Cancer Center - Froedtert Hospital Coordinator of this site? Confirm its status | Milwaukee | United States | Not yet recruiting |
| GI PROS, Inc. Coordinator of this site? Confirm its status | Naples | United States | Active, not recruiting |
| Columbia University Medical Center/New York-Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Lenox Hill Hospital | Northwell Health Coordinator of this site? Confirm its status | New York | United States | Active, not recruiting |
| Orlando Health Ambulatory Care Center Coordinator of this site? Confirm its status | Orlando | United States | Active, not recruiting |
| Rapid City Medical Center Coordinator of this site? Confirm its status | Rapid City | United States | Active, not recruiting |
| Southern Star Research Institute, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| Swedish Cancer Institute Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| University of Washington Medical Center - Montlake Coordinator of this site? Confirm its status | Seattle | United States | Not yet recruiting |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Active, not recruiting |
| USF Health Morsani Center for Advanced Healthcare Coordinator of this site? Confirm its status | Tampa | United States | Active, not recruiting |
| Tyler Research Institute, LLC Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
Related publications
- Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease.Contemp Clin Trials Commun · 2025 · PMID 41403476
This page is information, not medical advice. Discuss any trial with your doctor.