Crohn'sRecruiting
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Phase 3 · Testing Vedolizumab and Upadacitinib · 138 sites · Takeda
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Vedolizumab (a drug) and Upadacitinib (a drug) as a possible treatment. Condition(s) listed: Crohn's Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 396 participants are expected to take part.
- Start date: 2025-01-02.
- Main results expected around 2027-06-08 (estimate from the record).
- 138 study sites listed (8 marked recruiting) in Austria, Belgium, Brazil, Canada and Croatia and 21 more countries.
Main thing being measured
- Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 (Week 12)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Takeda |
| Enrollment | 396 (estimated) |
| Start date | 2025-01-02 |
| Primary completion (est.) | 2027-06-08 |
| First posted | 2024-01-29 |
| Last updated | 2026-05-27 |
| 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 |
| ClinicalTrials.gov ID | NCT06227910 |
Interventions
- Vedolizumab (Drug)
Vedolizumab IV infusion. - Upadacitinib (Drug)
Upadacitinib over-encapsulated tablets. - Placebo (Drug)
Upadacitinib matched placebo capsules.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. 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. 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 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: 1. The participant has a current diagnosis of ulcerative colitis or indeterminate colitis. 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.
Locations (138)
Show all 138 sites
| Site | City | Country | Site status |
|---|---|---|---|
| UCSD Medical Center | La Jolla, California | United States | Not yet recruiting |
| Keck Medicine Of USC - USC Healthcare Center 1 | Los Angeles, California | United States | Not yet recruiting |
| Peak Gastroenterology Associates | Colorado Springs, Colorado | United States | Recruiting |
| GI PROS, Inc. | Naples, Florida | United States | Active, not recruiting |
| Orlando Health Ambulatory Care Center | Orlando, Florida | United States | Active, not recruiting |
| USF Health Morsani Center for Advanced Healthcare | Tampa, Florida | United States | Active, not recruiting |
| Indiana University (IU) Health University Hospital | Indianapolis, Indiana | United States | Active, not recruiting |
| University of Kentucky | Lexington, Kentucky | United States | Active, not recruiting |
| Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center | New York, New York | United States | Active, not recruiting |
| Columbia University Medical Center, New York-Presbyterian Hospital | New York, New York | United States | Not yet recruiting |
| Lenox Hill Hospital Northwell Health | New York, New York | United States | Active, not recruiting |
| Gastroenterology Associates | Greenville, South Carolina | United States | Active, not recruiting |
| Rapid City Medical Center | Rapid City, South Dakota | United States | Active, not recruiting |
| Southern Star Research Institute, LLC | San Antonio, Texas | United States | Recruiting |
| Tyler Research Institute, LLC | Tyler, Texas | United States | Recruiting |
| Virginia Mason Medical Center | Seattle, Washington | United States | Active, not recruiting |
| Swedish Cancer Institute | Seattle, Washington | United States | Not yet recruiting |
| University of Washington Medical Center - Montlake | Seattle, Washington | United States | Not yet recruiting |
| Medical College of Wisconsin Cancer Center - Froedtert Hospital | Milwaukee, Wisconsin | United States | Not yet recruiting |
| Johannes Kepler Universitat Linz (JKU) | Linz | Austria | Not yet recruiting |
| Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss | Salzburg | Austria | Not yet recruiting |
| Krankenhaus der Barmherzigen Brueder Wien | Vienna | Austria | Not yet recruiting |
| Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III | Vienna, State of Vienna | Austria | Not yet recruiting |
| Medical University Innsbruck | Innsbruck, Tyrol | Austria | Not yet recruiting |
| Imelda GI Clinical Research Center | Bonheiden | Belgium | Active, not recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Not yet recruiting |
| University Hospitals Leuven | Leuven | Belgium | Not yet recruiting |
| Centre Hospitalier Chretien MontLegia | Liège | Belgium | Not yet recruiting |
| Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel | Brussels, Anderlecht | Belgium | Not yet recruiting |
| Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF) | Rio de Janeiro | 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)) | São Paulo | Brazil | Not yet recruiting |
| Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo | São Paulo | Brazil | Not yet recruiting |
| Hospital Universitario Cajuru | Curitiba, Paraná | Brazil | Not yet recruiting |
| Faculdade de Medicina de Botucatu | Botucatu, São Paulo | Brazil | Not yet recruiting |
| Centro de Estudos Clinico do Interior Paulista - CECIP | Jaú, São Paulo | Brazil | Not yet recruiting |
| Pesquisare Saude | Santo André, São Paulo | Brazil | Not yet recruiting |
| Heritage Medical Research Clinic - University Of Calgary | Calgary, Alberta | Canada | Active, not recruiting |
| University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre | Winnipeg, Manitoba | Canada | Not yet recruiting |
| Dalhousie University | Halifax, Nova Scotia | Canada | Not yet recruiting |
| Barrie GI Associates | Barrie, Ontario | Canada | Recruiting |
| McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI) | Hamilton, Ontario | Canada | Active, not recruiting |
| Taunton Surgical Centre-Oshawa Clinic | Oshawa, Ontario | Canada | Recruiting |
| Toronto Immune and Digestive Health Institute (TIDHI) | Toronto, Ontario | Canada | Recruiting |
| Toronto Digestive Disease Associates | Vaughan, Ontario | Canada | Not yet recruiting |
| Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec | Canada | Not yet recruiting |
| Poliklinika Borzan d.o.o. | Osijek | Croatia | Not yet recruiting |
| Clinical Hospital Center Rijeka | Rijeka | Croatia | Active, not recruiting |
| University Hospital Centre Sestre Milosrdnice | Zagreb | Croatia | Not yet recruiting |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | Czechia | Not yet recruiting |
| Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové | Czechia | Not yet recruiting |
| IBD Clinical and Research centre | Prague | Czechia | Not yet recruiting |
| Nemocnice Ceske Budejovice, a.s. | České Budějovice | Czechia | Not yet recruiting |
| Aalborg Hospital | Aalborg | Denmark | Not yet recruiting |
| Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling | Hvidovre | Denmark | Not yet recruiting |
| CHU d'Amiens-Picardie - Hopital SUD | Amiens | France | Not yet recruiting |
| Hopital Huriez - CHRU de Lille | Lille | France | Not yet recruiting |
| Chu - Hopital Nord | Marseille | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu | Nantes | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque | Pessac | France | Active, not recruiting |
| CHU St Etienne Hopital Nord | Saint-Etienne | France | Not yet recruiting |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil | Toulouse | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois | Vandœuvre-lès-Nancy | France | Not yet recruiting |
| Krankenhaus Waldfriede e.V. | Berlin | Germany | Not yet recruiting |
| Agaplesion Markus Krankenhaus | Frankfurt am Main | Germany | Not yet recruiting |
| Studiengesellschaft BSF | Halle | Germany | Not yet recruiting |
| Universitaetsklinikum Jena | Jena | Germany | Not yet recruiting |
| Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel | Kiel | Germany | Not yet recruiting |
| St. Marien- und St. Annastiftskrankenhaus | Ludwigshafen | Germany | Not yet recruiting |
| Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik | Mannheim | Germany | Not yet recruiting |
| University of Athens School of Medicine, Alexandra General Hospital | Athens, Attica | Greece | Not yet recruiting |
| Metaxa Cancer Hospital | Piraeus, Attica | Greece | Not yet recruiting |
| University Hospital of Heraklion | Heraklion, Crete | Greece | Not yet recruiting |
| Central Hospital of Northern Pest - Military Hospital | Budapest | Hungary | Not yet recruiting |
| Semmelweis Egyetem | Budapest | Hungary | Not yet recruiting |
| Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika | Szeged | Hungary | Not yet recruiting |
| Adelaide, Meath and National Children's Hospital | Dublin | Ireland | Not yet recruiting |
| University College Dublin (UCD) - St. Vincent's University Hospital (SVUH) | Dublin | Ireland | Not yet recruiting |
| Beaumont Hospital | Dublin | Ireland | Not yet recruiting |
| Soroka Medical Center | Beersheba | Israel | Not yet recruiting |
| Rambam Health Care Campus (RHCC) | Haifa | Israel | Not yet recruiting |
| Meir Medical Center | Kfar Saba | Israel | Not yet recruiting |
| Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital) | Petah Tikva | Israel | Not yet recruiting |
| The Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | Not yet recruiting |
| Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Federico II di Napoli | Naples | Italy | Not yet recruiting |
| A. Gemelli University Hospital, Catholic University of the Sacred Heart | Roma | Italy | Not yet recruiting |
| Humanitas Clinical And Research Institute | Rozzano | Italy | Not yet recruiting |
| Fondazione IRCSS Casa Sollievo Della Sofferenza | San Giovanni Rotondo | Italy | Not yet recruiting |
| AO Ordine Mauriziano di Torino | Torino | Italy | Not yet recruiting |
| Amsterdam UMC Research BV | Amsterdam | Netherlands | Not yet recruiting |
| Radboud University Medical Center | Nijmegen | Netherlands | Not yet recruiting |
| Erasmus Medisch Centrum | Rotterdam | Netherlands | Not yet recruiting |
| Elisabeth TweeSteden Ziekenhuis (ETZ) | Tilburg | Netherlands | Not yet recruiting |
| Haukeland Universitetssjukehus (Haukeland University Hospital) | Bergen | Norway | Not yet recruiting |
| Akershus University Hospital | Lorenskog | Norway | Not yet recruiting |
| Oslo Universitetssykehus HF, Ulleval | Oslo | Norway | Not yet recruiting |
| Vestre Viken HF - Baerum Sykehus | Drammen, Gjettum | Norway | Not yet recruiting |
| Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi | Lodz | Poland | Not yet recruiting |
| Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um | Poznan | Poland | Not yet recruiting |
| H-T. Centrum Medyczne Sp. z o.o. Sp.k. | Tychy | Poland | Not yet recruiting |
| Panstwowy Instytut Medyczny MSWiA | Warsaw | Poland | Not yet recruiting |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Poland | Not yet recruiting |
| Unidade Local de Saude Coimbra | Coimbra | Portugal | Not yet recruiting |
| Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz | Lisbon | Portugal | Not yet recruiting |
| Centro Hospitalar Universitario Lisboa Norte EPE | Lisbon | Portugal | Not yet recruiting |
| University Clinical Centre - Ljubljana | Ljubljana | Slovenia | Not yet recruiting |
| Inje University Haeundae Paik Hospital | Busan | South Korea | Recruiting |
| Yeungnam University Medical Center | Daegu | South Korea | Active, not recruiting |
| The Catholic University of Korea, Daejeon St.Mary's Hospital | Daejeon | South Korea | Active, not recruiting |
| Kyung Hee University Hospital | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea | Active, not recruiting |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea | Active, not recruiting |
| Chung-Ang University Hospital | Seoul | South Korea | Active, not recruiting |
| The Catholic University Of Korea, St. Vincent's Hospital | Suwon | South Korea | Active, not recruiting |
| Hospital General Universitario Gregorio Maranon (HGUGM) | Madrid | Spain | Active, not recruiting |
| Hospital Universitario La Paz | Madrid | Spain | Active, not recruiting |
| Hospital Universitari Son Espases | Palma | Spain | Not yet recruiting |
| Complejo Hospitalario de Navarra (CHN) | Pamplona | Spain | Active, not recruiting |
| Complejo Hospitalario Universitario De Santiago De Compostela | Santiago de Compostela | Spain | Not yet recruiting |
| Hospital Universitari I Politecnic La Fe | Valencia | Spain | Not yet recruiting |
| Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken) | Linköping | Sweden | Not yet recruiting |
| Ersta sjukhus | Stockholm | Sweden | Not yet recruiting |
| Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital | Stockholm | Sweden | Not yet recruiting |
| Danderyds Sjukhus AB | Stockholm | Sweden | Not yet recruiting |
| University Hospital Basel | Basel | Switzerland | Not yet recruiting |
| University Hospital Bern (Inselspital) | Bern | Switzerland | Not yet recruiting |
| Zentrum fur Gastroenterologie | Zurich | Switzerland | Not yet recruiting |
| Universitatsspital Zurich | Zurich | Switzerland | Not yet recruiting |
| Changhua Christian Hospital | Changhua | Taiwan | Not yet recruiting |
| Chung Shan Medical University Hospital | Taichung | Taiwan | Not yet recruiting |
| Taichung Veterans General Hospital | Taichung | Taiwan | Not yet recruiting |
| National Cheng Kung University Hospital | Tainan | Taiwan | Not yet recruiting |
| National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu | Taipei | Taiwan | Not yet recruiting |
| Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital | Taoyuan City | Taiwan | Not yet recruiting |
| St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust | London, England | United Kingdom | Not yet recruiting |
| The Royal London Hospital - Barts Health NHS Trust | London, Greater London | United Kingdom | Not yet recruiting |
| Western General Hospital | Edinburgh, Lothian | United Kingdom | Not yet recruiting |
| Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division | Glasgow, Scotland | United Kingdom | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.