New drug combo aims to heal gut in Crohn's patients

NCT ID NCT06227910

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving two drugs together (vedolizumab and upadacitinib) for 12 weeks works better than vedolizumab alone to reduce bowel inflammation and ulcers in adults with moderate to severe Crohn's disease. About 396 participants will receive the combo or a placebo combo, then all responders switch to vedolizumab alone for 40 more weeks. The goal is to see if the initial combo leads to better long-term control of the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 396 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

112 sites in 26 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

A. Gemelli University Hospital, Catholic University of the Sacred Heart
NOT_YET_RECRUITING

Roma, 00168, Italy
AO Ordine Mauriziano di Torino
NOT_YET_RECRUITING

Torino, 10122, Italy
Aalborg Hospital
NOT_YET_RECRUITING

Aalborg, 9000, Denmark
Adelaide, Meath and National Children's Hospital
NOT_YET_RECRUITING

Dublin, 24, Ireland
Agaplesion Markus Krankenhaus
NOT_YET_RECRUITING

Frankfurt am Main, 60431, Germany
Akershus University Hospital
NOT_YET_RECRUITING

Lorenskog, 1478, Norway
Amsterdam UMC Research BV
NOT_YET_RECRUITING

Amsterdam, 1105 AZ, Netherlands
Azienda Ospedaliero Universitaria Federico II di Napoli
NOT_YET_RECRUITING

Naples, 80131, Italy
Barrie GI Associates
RECRUITING

Barrie, Ontario, L4M 7G1, Canada
Beaumont Hospital
NOT_YET_RECRUITING

Dublin, D09 V2N0, Ireland
CHU St Etienne Hopital Nord
NOT_YET_RECRUITING

Saint-Etienne, 42270, France
CHU d'Amiens-Picardie - Hopital SUD
NOT_YET_RECRUITING

Amiens, 80054, France
Central Hospital of Northern Pest - Military Hospital
NOT_YET_RECRUITING

Budapest, 1062, Hungary
Centre Hospitalier Chretien MontLegia
NOT_YET_RECRUITING

Liège, 4000, Belgium
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
NOT_YET_RECRUITING

Vandœuvre-lès-Nancy, 54511, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
ACTIVE_NOT_RECRUITING

Toulouse, 31059, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
ACTIVE_NOT_RECRUITING

Pessac, 33600, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
ACTIVE_NOT_RECRUITING

Nantes, 44093, France
Centre Hospitalier de l'Universite de Montreal
NOT_YET_RECRUITING

Montreal, Quebec, H2X 0A9, Canada
Centro Hospitalar Universitario Lisboa Norte EPE
NOT_YET_RECRUITING

Lisbon, 1649-028, Portugal
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
NOT_YET_RECRUITING

Lisbon, 1349-019, Portugal
Centro de Estudos Clinico do Interior Paulista - CECIP
NOT_YET_RECRUITING

Jaú, São Paulo, 17201130, Brazil
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
NOT_YET_RECRUITING

Taoyuan City, 33305, Taiwan
Changhua Christian Hospital
NOT_YET_RECRUITING

Changhua, 50006, Taiwan
Chu - Hopital Nord
NOT_YET_RECRUITING

Marseille, 13015, France
Chung Shan Medical University Hospital
NOT_YET_RECRUITING

Taichung, 40201, Taiwan
Chung-Ang University Hospital
ACTIVE_NOT_RECRUITING

Seoul, 06973, South Korea
Clinical Hospital Center Rijeka
ACTIVE_NOT_RECRUITING

Rijeka, 51000, Croatia
Columbia University Medical Center, New York-Presbyterian Hospital
NOT_YET_RECRUITING

New York, New York, 10032, United States
Complejo Hospitalario Universitario De Santiago De Compostela
NOT_YET_RECRUITING

Santiago de Compostela, 15706, Spain
Complejo Hospitalario de Navarra (CHN)
ACTIVE_NOT_RECRUITING

Pamplona, 31008, Spain
Dalhousie University
NOT_YET_RECRUITING

Halifax, Nova Scotia, B3H 2Y9, Canada
Danderyds Sjukhus AB
NOT_YET_RECRUITING

Stockholm, 182 88, Sweden
Elisabeth TweeSteden Ziekenhuis (ETZ)
NOT_YET_RECRUITING

Tilburg, 5022 GC, Netherlands
Erasmus Medisch Centrum
NOT_YET_RECRUITING

Rotterdam, 3015 GD, Netherlands
Ersta sjukhus
NOT_YET_RECRUITING

Stockholm, 116 30, Sweden
Faculdade de Medicina de Botucatu
NOT_YET_RECRUITING

Botucatu, São Paulo, 18618-970, Brazil
Fakultni Nemocnice Hradec Kralove
NOT_YET_RECRUITING

Hradec Králové, 500 05, Czechia
Fondazione IRCSS Casa Sollievo Della Sofferenza
NOT_YET_RECRUITING

San Giovanni Rotondo, 71013, Italy
GI PROS, Inc.
ACTIVE_NOT_RECRUITING

Naples, Florida, 34102, United States
Gastroenterology Associates
ACTIVE_NOT_RECRUITING

Greenville, South Carolina, 29607, United States
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
NOT_YET_RECRUITING

Tychy, 43-100, Poland
Haukeland Universitetssjukehus (Haukeland University Hospital)
NOT_YET_RECRUITING

Bergen, N5021, Norway
Hepato-Gastroenterologie HK, s.r.o.
NOT_YET_RECRUITING

Hradec Králové, 500 12, Czechia
Heritage Medical Research Clinic - University Of Calgary
ACTIVE_NOT_RECRUITING

Calgary, Alberta, T2N 4Z6, Canada
Hopital Huriez - CHRU de Lille
NOT_YET_RECRUITING

Lille, 59037, France
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
NOT_YET_RECRUITING

Brussels, Anderlecht, 1070, Belgium
Hospital General Universitario Gregorio Maranon (HGUGM)
ACTIVE_NOT_RECRUITING

Madrid, 28007, Spain
Hospital Universitari I Politecnic La Fe
NOT_YET_RECRUITING

Valencia, 46026, Spain
Hospital Universitari Son Espases
NOT_YET_RECRUITING

Palma, 07120, Spain
Hospital Universitario Cajuru
NOT_YET_RECRUITING

Curitiba, Paraná, 80050-350, Brazil
Hospital Universitario La Paz
ACTIVE_NOT_RECRUITING

Madrid, 28046, Spain
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, 05403-010, Brazil
Humanitas Clinical And Research Institute
NOT_YET_RECRUITING

Rozzano, 20089, Italy
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
NOT_YET_RECRUITING

Hvidovre, 2650, Denmark
IBD Clinical and Research centre
NOT_YET_RECRUITING

Prague, 190 00, Czechia
Imelda GI Clinical Research Center
ACTIVE_NOT_RECRUITING

Bonheiden, 2820, Belgium
Indiana University (IU) Health University Hospital
ACTIVE_NOT_RECRUITING

Indianapolis, Indiana, 46202, United States
Inje University Haeundae Paik Hospital
RECRUITING

Busan, 48108, South Korea
Johannes Kepler Universitat Linz (JKU)
NOT_YET_RECRUITING

Linz, 4021, Austria
Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
NOT_YET_RECRUITING

Stockholm, 171 76, Sweden
Keck Medicine Of USC - USC Healthcare Center 1
NOT_YET_RECRUITING

Los Angeles, California, 90033, United States
Krankenhaus Waldfriede e.V.
NOT_YET_RECRUITING

Berlin, 14163, Germany
Krankenhaus der Barmherzigen Brueder Wien
NOT_YET_RECRUITING

Vienna, 1020, Austria
Kyung Hee University Hospital
RECRUITING

Seoul, 02447, South Korea
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
NOT_YET_RECRUITING

Salzburg, 5020, Austria
Lenox Hill Hospital Northwell Health
ACTIVE_NOT_RECRUITING

New York, New York, 10075, United States
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
ACTIVE_NOT_RECRUITING

Hamilton, Ontario, L8S 4K1, Canada
Medical College of Wisconsin Cancer Center - Froedtert Hospital
NOT_YET_RECRUITING

Milwaukee, Wisconsin, 53226, United States
Medical University Innsbruck
NOT_YET_RECRUITING

Innsbruck, Tyrol, 6020, Austria
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
NOT_YET_RECRUITING

Vienna, State of Vienna, 1090, Austria
Meir Medical Center
NOT_YET_RECRUITING

Kfar Saba, 44281, Israel
Metaxa Cancer Hospital
NOT_YET_RECRUITING

Piraeus, Attica, 185 37, Greece
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
ACTIVE_NOT_RECRUITING

New York, New York, 10029-5204, United States
National Cheng Kung University Hospital
NOT_YET_RECRUITING

Tainan, 70403, Taiwan
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
NOT_YET_RECRUITING

Taipei, 11490, Taiwan
Nemocnice Ceske Budejovice, a.s.
NOT_YET_RECRUITING

České Budějovice, 370 01, Czechia
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
NOT_YET_RECRUITING

Lodz, 90-153, Poland
Orlando Health Ambulatory Care Center
ACTIVE_NOT_RECRUITING

Orlando, Florida, 32806, United States
Oslo Universitetssykehus HF, Ulleval
NOT_YET_RECRUITING

Oslo, 0424, Norway
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
NOT_YET_RECRUITING

Milan, 20132, Italy
Panstwowy Instytut Medyczny MSWiA
NOT_YET_RECRUITING

Warsaw, 02-507, Poland
Peak Gastroenterology Associates
RECRUITING

Colorado Springs, Colorado, 80907, United States
Pesquisare Saude
NOT_YET_RECRUITING

Santo André, São Paulo, 9080110, Brazil
Poliklinika Borzan d.o.o.
NOT_YET_RECRUITING

Osijek, 31000, Croatia
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
NOT_YET_RECRUITING

Glasgow, Scotland, G51 4TF, United Kingdom
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
NOT_YET_RECRUITING

Petah Tikva, 49100, Israel
Radboud University Medical Center
NOT_YET_RECRUITING

Nijmegen, 6525 GA, Netherlands
Rambam Health Care Campus (RHCC)
NOT_YET_RECRUITING

Haifa, 3109601, Israel
Rapid City Medical Center
ACTIVE_NOT_RECRUITING

Rapid City, South Dakota, 57701, United States
Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
NOT_YET_RECRUITING

Poznan, 60-354, Poland
Semmelweis Egyetem
NOT_YET_RECRUITING

Budapest, 1082, Hungary
Severance Hospital, Yonsei University Health System
ACTIVE_NOT_RECRUITING

Seoul, 03722, South Korea
Soroka Medical Center
NOT_YET_RECRUITING

Beersheba, 8410101, Israel
Southern Star Research Institute, LLC
RECRUITING

San Antonio, Texas, 78229, United States
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
NOT_YET_RECRUITING

London, England, SE1 7EH, United Kingdom
St. Marien- und St. Annastiftskrankenhaus
NOT_YET_RECRUITING

Ludwigshafen, 67065, Germany
Studiengesellschaft BSF
NOT_YET_RECRUITING

Halle, 06108, Germany
Swedish Cancer Institute
NOT_YET_RECRUITING

Seattle, Washington, 98104, United States
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
NOT_YET_RECRUITING

Szeged, 6720, Hungary
Taichung Veterans General Hospital
NOT_YET_RECRUITING

Taichung, 40705, Taiwan
Taunton Surgical Centre-Oshawa Clinic
RECRUITING

Oshawa, Ontario, L1J 0C7, Canada
The Catholic University Of Korea, St. Vincent's Hospital
ACTIVE_NOT_RECRUITING

Suwon, 16247, South Korea
The Catholic University of Korea, Daejeon St.Mary's Hospital
ACTIVE_NOT_RECRUITING

Daejeon, 34943, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
ACTIVE_NOT_RECRUITING

Seoul, 06591, South Korea
The Royal London Hospital - Barts Health NHS Trust
NOT_YET_RECRUITING

London, Greater London, E1 1BB, United Kingdom
The Tel Aviv Sourasky Medical Center
NOT_YET_RECRUITING

Tel Aviv, 6423906, Israel
Toronto Digestive Disease Associates
NOT_YET_RECRUITING

Vaughan, Ontario, L4L 4Y7, Canada
Toronto Immune and Digestive Health Institute (TIDHI)
RECRUITING

Toronto, Ontario, M6A 3B4, Canada
Tyler Research Institute, LLC
RECRUITING

Tyler, Texas, 75701, United States
UCSD Medical Center
NOT_YET_RECRUITING

La Jolla, California, 92037, United States
USF Health Morsani Center for Advanced Healthcare
ACTIVE_NOT_RECRUITING

Tampa, Florida, 33612, United States
Unidade Local de Saude Coimbra
NOT_YET_RECRUITING

Coimbra, 3000-075, Portugal
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, 1405-1243, Brazil
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
NOT_YET_RECRUITING

Rio de Janeiro, 21941-617, Brazil
Universitaetsklinikum Jena
NOT_YET_RECRUITING

Jena, 07747, Germany
Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
NOT_YET_RECRUITING

Mannheim, 68167, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
NOT_YET_RECRUITING

Kiel, 24105, Germany
Universitair Ziekenhuis Gent
NOT_YET_RECRUITING

Ghent, 9000, Belgium
Universitatsspital Zurich
NOT_YET_RECRUITING

Zurich, 8091, Switzerland
Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
NOT_YET_RECRUITING

Linköping, Sweden
University Clinical Centre - Ljubljana
NOT_YET_RECRUITING

Ljubljana, 1000, Slovenia
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
NOT_YET_RECRUITING

Dublin, D04 T6F4, Ireland
University Hospital Basel
NOT_YET_RECRUITING

Basel, 4031, Switzerland
University Hospital Bern (Inselspital)
NOT_YET_RECRUITING

Bern, 3010, Switzerland
University Hospital Centre Sestre Milosrdnice
NOT_YET_RECRUITING

Zagreb, 10000, Croatia
University Hospital of Heraklion
NOT_YET_RECRUITING

Heraklion, Crete, 71110, Greece
University Hospitals Leuven
NOT_YET_RECRUITING

Leuven, 3000, Belgium
University of Athens School of Medicine, Alexandra General Hospital
NOT_YET_RECRUITING

Athens, Attica, 11528, Greece
University of Kentucky
ACTIVE_NOT_RECRUITING

Lexington, Kentucky, 40536, United States
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
NOT_YET_RECRUITING

Winnipeg, Manitoba, R3A 1R9, Canada
University of Washington Medical Center - Montlake
NOT_YET_RECRUITING

Seattle, Washington, 98195, United States
Vestre Viken HF - Baerum Sykehus
NOT_YET_RECRUITING

Drammen, Gjettum, 1309, Norway
Virginia Mason Medical Center
ACTIVE_NOT_RECRUITING

Seattle, Washington, 98101, United States
WIP Warsaw IBD Point Profesor Kierkus
NOT_YET_RECRUITING

Warsaw, 05-401, Poland
Western General Hospital
NOT_YET_RECRUITING

Edinburgh, Lothian, EH4 2XU, United Kingdom
Yeungnam University Medical Center
ACTIVE_NOT_RECRUITING

Daegu, 42415, South Korea
Zentrum fur Gastroenterologie
NOT_YET_RECRUITING

Zurich, 8048, Switzerland

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