Actively Recruiting
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Led by Takeda · Updated on 2025-06-03
396
Participants Needed
138
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Crohn's Disease for at least 3 months confirmed by clinical and endoscopic evidence with histopathology report
- Moderately to severely active Crohn's Disease assessed by a Crohn's Disease Activity Index (CDAI) score between 220 and 450
- Evidence of mucosal inflammation with a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 6 or higher, or 4 or higher for isolated ileal disease, confirmed by a central reader
- History of inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators, or biologic treatments
You will not qualify if you...
- Diagnosis of ulcerative colitis or indeterminate colitis
- Infection requiring intravenous anti-infective treatment within 30 days or oral/intramuscular treatment within 14 days before baseline
- Active infection during screening, clinically significant infection within 30 days before screening, or ongoing chronic infection
- History of recurrent or disseminated herpes zoster or herpes simplex
- Ongoing complications of Crohn's Disease such as abscess, symptomatic bowel strictures, missing bowel segments, fulminant colitis, toxic megacolon, or conditions requiring surgery during the study
- Presence of an ostomy or ileoanal pouch
- Severe kidney impairment with estimated glomerular filtration rate below 30 mL/min/1.73 m²
- Severe liver impairment classified as Child-Pugh C
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 138 locations
1
UCSD Medical Center
La Jolla, California, United States, 92037
Not Yet Recruiting
2
Keck Medicine Of USC - USC Healthcare Center 1
Los Angeles, California, United States, 90033
Not Yet Recruiting
3
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Actively Recruiting
4
GI PROS, Inc.
Naples, Florida, United States, 34102
Active, Not Recruiting
5
Orlando Health Ambulatory Care Center
Orlando, Florida, United States, 32806
Active, Not Recruiting
6
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, United States, 33612
Active, Not Recruiting
7
Indiana University (IU) Health University Hospital
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
8
University of Kentucky
Lexington, Kentucky, United States, 40536
Active, Not Recruiting
9
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
New York, New York, United States, 10029-5204
Active, Not Recruiting
10
Columbia University Medical Center, New York-Presbyterian Hospital
New York, New York, United States, 10032
Not Yet Recruiting
11
Lenox Hill Hospital Northwell Health
New York, New York, United States, 10075
Active, Not Recruiting
12
Gastroenterology Associates
Greenville, South Carolina, United States, 29607
Active, Not Recruiting
13
Rapid City Medical Center
Rapid City, South Dakota, United States, 57701
Active, Not Recruiting
14
Southern Star Research Institute, LLC
San Antonio, Texas, United States, 78229
Actively Recruiting
15
Tyler Research Institute, LLC
Tyler, Texas, United States, 75701
Actively Recruiting
16
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Active, Not Recruiting
17
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Not Yet Recruiting
18
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Not Yet Recruiting
19
Medical College of Wisconsin Cancer Center - Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
20
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, State of Vienna, Austria, 1090
Not Yet Recruiting
21
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Not Yet Recruiting
22
Johannes Kepler Universitat Linz (JKU)
Linz, Austria, 4021
Not Yet Recruiting
23
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
Salzburg, Austria, 5020
Not Yet Recruiting
24
Krankenhaus der Barmherzigen Brueder Wien
Vienna, Austria, 1020
Not Yet Recruiting
25
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht, Belgium, 1070
Not Yet Recruiting
26
Imelda GI Clinical Research Center
Bonheiden, Belgium, 2820
Active, Not Recruiting
27
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Not Yet Recruiting
28
University Hospitals Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
29
Centre Hospitalier Chretien MontLegia
Liège, Belgium, 4000
Not Yet Recruiting
30
Hospital Universitario Cajuru
Curitiba, Paraná, Brazil, 80050-350
Not Yet Recruiting
31
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil, 18618-970
Not Yet Recruiting
32
Centro de Estudos Clinico do Interior Paulista - CECIP
Jaú, São Paulo, Brazil, 17201130
Not Yet Recruiting
33
Pesquisare Saude
Santo André, São Paulo, Brazil, 9080110
Not Yet Recruiting
34
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, Brazil, 21941-617
Not Yet Recruiting
35
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, 05403-010
Not Yet Recruiting
36
Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
São Paulo, Brazil, 1405-1243
Not Yet Recruiting
37
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Active, Not Recruiting
38
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Not Yet Recruiting
39
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Not Yet Recruiting
40
Barrie GI Associates
Barrie, Ontario, Canada, L4M 7G1
Actively Recruiting
41
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
Hamilton, Ontario, Canada, L8S 4K1
Active, Not Recruiting
42
Taunton Surgical Centre-Oshawa Clinic
Oshawa, Ontario, Canada, L1J 0C7
Actively Recruiting
43
Toronto Immune and Digestive Health Institute (TIDHI)
Toronto, Ontario, Canada, M6A 3B4
Actively Recruiting
44
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada, L4L 4Y7
Not Yet Recruiting
45
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 0A9
Not Yet Recruiting
46
Poliklinika Borzan d.o.o.
Osijek, Croatia, 31000
Not Yet Recruiting
47
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Active, Not Recruiting
48
University Hospital Centre Sestre Milosrdnice
Zagreb, Croatia, 10000
Not Yet Recruiting
49
Nemocnice Ceske Budejovice, a.s.
České Budějovice, Czechia, 370 01
Not Yet Recruiting
50
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Not Yet Recruiting
51
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, Czechia, 500 12
Not Yet Recruiting
52
IBD Clinical and Research centre
Prague, Czechia, 190 00
Not Yet Recruiting
53
Aalborg Hospital
Aalborg, Denmark, 9000
Not Yet Recruiting
54
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, Denmark, 2650
Not Yet Recruiting
55
CHU d'Amiens-Picardie - Hopital SUD
Amiens, France, 80054
Not Yet Recruiting
56
Hopital Huriez - CHRU de Lille
Lille, France, 59037
Not Yet Recruiting
57
Chu - Hopital Nord
Marseille, France, 13015
Not Yet Recruiting
58
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, France, 44093
Active, Not Recruiting
59
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, France, 33600
Active, Not Recruiting
60
CHU St Etienne Hopital Nord
Saint-Etienne, France, 42270
Not Yet Recruiting
61
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
Toulouse, France, 31059
Active, Not Recruiting
62
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
Vandœuvre-lès-Nancy, France, 54511
Not Yet Recruiting
63
Krankenhaus Waldfriede e.V.
Berlin, Germany, 14163
Not Yet Recruiting
64
Agaplesion Markus Krankenhaus
Frankfurt am Main, Germany, 60431
Not Yet Recruiting
65
Studiengesellschaft BSF
Halle, Germany, 06108
Not Yet Recruiting
66
Universitaetsklinikum Jena
Jena, Germany, 07747
Not Yet Recruiting
67
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, Germany, 24105
Not Yet Recruiting
68
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, Germany, 67065
Not Yet Recruiting
69
Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
Mannheim, Germany, 68167
Not Yet Recruiting
70
University of Athens School of Medicine, Alexandra General Hospital
Athens, Attica, Greece, 11528
Not Yet Recruiting
71
Metaxa Cancer Hospital
Piraeus, Attica, Greece, 185 37
Not Yet Recruiting
72
University Hospital of Heraklion
Heraklion, Crete, Greece, 71110
Not Yet Recruiting
73
Central Hospital of Northern Pest - Military Hospital
Budapest, Hungary, 1062
Not Yet Recruiting
74
Semmelweis Egyetem
Budapest, Hungary, 1082
Not Yet Recruiting
75
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
Szeged, Hungary, 6720
Not Yet Recruiting
76
Adelaide, Meath and National Children's Hospital
Dublin, Ireland, 24
Not Yet Recruiting
77
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
Dublin, Ireland, D04 T6F4
Not Yet Recruiting
78
Beaumont Hospital
Dublin, Ireland, D09 V2N0
Not Yet Recruiting
79
Soroka Medical Center
Beersheba, Israel, 8410101
Not Yet Recruiting
80
Rambam Health Care Campus (RHCC)
Haifa, Israel, 3109601
Not Yet Recruiting
81
Meir Medical Center
Kfar Saba, Israel, 44281
Not Yet Recruiting
82
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petah Tikva, Israel, 49100
Not Yet Recruiting
83
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Not Yet Recruiting
84
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
Milan, Italy, 20132
Not Yet Recruiting
85
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, Italy, 80131
Not Yet Recruiting
86
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, Italy, 00168
Not Yet Recruiting
87
Humanitas Clinical And Research Institute
Rozzano, Italy, 20089
Not Yet Recruiting
88
Fondazione IRCSS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy, 71013
Not Yet Recruiting
89
AO Ordine Mauriziano di Torino
Torino, Italy, 10122
Not Yet Recruiting
90
Amsterdam UMC Research BV
Amsterdam, Netherlands, 1105 AZ
Not Yet Recruiting
91
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Not Yet Recruiting
92
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
93
Elisabeth TweeSteden Ziekenhuis (ETZ)
Tilburg, Netherlands, 5022 GC
Not Yet Recruiting
94
Vestre Viken HF - Baerum Sykehus
Drammen, Gjettum, Norway, 1309
Not Yet Recruiting
95
Haukeland Universitetssjukehus (Haukeland University Hospital)
Bergen, Norway, N5021
Not Yet Recruiting
96
Akershus University Hospital
Lorenskog, Norway, 1478
Not Yet Recruiting
97
Oslo Universitetssykehus HF, Ulleval
Oslo, Norway, 0424
Not Yet Recruiting
98
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 90-153
Not Yet Recruiting
99
Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
Poznan, Poland, 60-354
Not Yet Recruiting
100
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, Poland, 43-100
Not Yet Recruiting
101
Panstwowy Instytut Medyczny MSWiA
Warsaw, Poland, 02-507
Not Yet Recruiting
102
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland, 05-401
Not Yet Recruiting
103
Unidade Local de Saude Coimbra
Coimbra, Portugal, 3000-075
Not Yet Recruiting
104
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
Lisbon, Portugal, 1349-019
Not Yet Recruiting
105
Centro Hospitalar Universitario Lisboa Norte EPE
Lisbon, Portugal, 1649-028
Not Yet Recruiting
106
University Clinical Centre - Ljubljana
Ljubljana, Slovenia, 1000
Not Yet Recruiting
107
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
108
Yeungnam University Medical Center
Daegu, South Korea, 42415
Active, Not Recruiting
109
The Catholic University of Korea, Daejeon St.Mary's Hospital
Daejeon, South Korea, 34943
Active, Not Recruiting
110
Kyung Hee University Hospital
Seoul, South Korea, 02447
Actively Recruiting
111
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Active, Not Recruiting
112
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Active, Not Recruiting
113
Chung-Ang University Hospital
Seoul, South Korea, 06973
Active, Not Recruiting
114
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, South Korea, 16247
Active, Not Recruiting
115
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, Spain, 28007
Active, Not Recruiting
116
Hospital Universitario La Paz
Madrid, Spain, 28046
Active, Not Recruiting
117
Hospital Universitari Son Espases
Palma, Spain, 07120
Not Yet Recruiting
118
Complejo Hospitalario de Navarra (CHN)
Pamplona, Spain, 31008
Active, Not Recruiting
119
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, Spain, 15706
Not Yet Recruiting
120
Hospital Universitari I Politecnic La Fe
Valencia, Spain, 46026
Not Yet Recruiting
121
Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
Linköping, Sweden
Not Yet Recruiting
122
Ersta sjukhus
Stockholm, Sweden, 116 30
Not Yet Recruiting
123
Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
Stockholm, Sweden, 171 76
Not Yet Recruiting
124
Danderyds Sjukhus AB
Stockholm, Sweden, 182 88
Not Yet Recruiting
125
University Hospital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
126
University Hospital Bern (Inselspital)
Bern, Switzerland, 3010
Not Yet Recruiting
127
Zentrum fur Gastroenterologie
Zurich, Switzerland, 8048
Not Yet Recruiting
128
Universitatsspital Zurich
Zurich, Switzerland, 8091
Not Yet Recruiting
129
Changhua Christian Hospital
Changhua, Taiwan, 50006
Not Yet Recruiting
130
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Not Yet Recruiting
131
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Not Yet Recruiting
132
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Not Yet Recruiting
133
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
Taipei, Taiwan, 11490
Not Yet Recruiting
134
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 33305
Not Yet Recruiting
135
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, England, United Kingdom, SE1 7EH
Not Yet Recruiting
136
The Royal London Hospital - Barts Health NHS Trust
London, Greater London, United Kingdom, E1 1BB
Not Yet Recruiting
137
Western General Hospital
Edinburgh, Lothian, United Kingdom, EH4 2XU
Not Yet Recruiting
138
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
Glasgow, Scotland, United Kingdom, G51 4TF
Not Yet Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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