Phase
Condition
Crohn's Disease
Colic
Ulcerative Colitis
Treatment
Placebo
Vedolizumab
Upadacitinib
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant has a diagnosis of CD established at least 3 months before screeningby clinical and endoscopic evidence and corroborated by a histopathology report.
The participant has a confirmed diagnosis of moderately to severely active CD asassessed by CDAI of 220-450.
The participant has evidence of mucosal inflammation based on the SES-CD: SES-CDscore (excluding the presence of narrowing component) of >=6 (or >=4 forparticipants with isolated ileal disease), as confirmed by a central reader.
The participant has demonstrated an inadequate response to, loss of response to, orintolerance to corticosteroids, immunomodulators, or biologic therapy.
Exclusion
Exclusion Criteria:
The participant has a current diagnosis of ulcerative colitis or indeterminatecolitis.
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 priorto baseline.
The participant has evidence of an active infection during the screening period, orclinically significant infection within 30 days prior to screening, or ongoingchronic infection.
The participant has a history of recurrent or disseminated (including a singleepisode) herpes zoster, or disseminated (including a single episode) herpes simplex.
The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments ofthe following 5 segments: terminal ileum, right colon, transverse colon, sigmoid andleft colon, and rectum; fulminant colitis; toxic megacolon; or any othermanifestation that might require surgery while enrolled in the study.
The participant has an ostomy or ileoanal pouch.
The participant has severe renal impairment, defined as an estimated glomerularfiltration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).
The participant has severe (Child-Pugh C) hepatic impairment.
Study Design
Study Description
Connect with a study center
Medical University Innsbruck
Innsbruck, Tyrol 6020
AustriaSite Not Available
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Wien, Vienna 1090
AustriaSite Not Available
Johannes Kepler Universitat Linz (JKU)
Linz, 4021
AustriaSite Not Available
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
Salzburg, 5020
AustriaSite Not Available
Krankenhaus der Barmherzigen Brueder Wien
Wien, 1020
AustriaSite Not Available
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussel, Anderlecht 1070
BelgiumSite Not Available
Imelda GI Clinical Research Center
Bonheiden, 2820
BelgiumSite Not Available
Universitair Ziekenhuis Gent
Gent, 9000
BelgiumSite Not Available
University Hospitals Leuven
Leuven, 3000
BelgiumSite Not Available
Centre Hospitalier Chretien MontLegia
Liege, 4000
BelgiumSite Not Available
Hospital Universitario Cajuru
Curitiba, Parana 80050-350
BrazilSite Not Available
Faculdade de Medicina de Botucatu
Botucatu, Sao Paulo 18618-970
BrazilSite Not Available
Centro de Estudos Clinico do Interior Paulista - CECIP
Jau, Sao Paulo 17201130
BrazilSite Not Available
Pesquisare Saude
Santo Andre, Sao Paulo 9080110
BrazilSite Not Available
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio De Janeiro, 21941-617
BrazilSite Not Available
Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC/FMUSP))
Sao Paulo, 05403-010
BrazilSite Not Available
Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Sao Paulo, 1405-1243
BrazilSite Not Available
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
Winnipeg, Manitoba R3A 1R9
CanadaSite Not Available
Dalhousie University
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Barrie GI Associates
Barrie, Ontario L4M 7G1
CanadaActive - Recruiting
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
Hamilton, Ontario L8S 4K1
CanadaSite Not Available
Toronto Immune and Digestive Health Institute (TIDHI)
North York, Ontario M6A 3B4
CanadaSite Not Available
Taunton Surgical Centre-Oshawa Clinic
Oshawa, Ontario L1J 0C7
CanadaActive - Recruiting
Toronto Immune and Digestive Health Institute (TIDHI)
Toronto, Ontario M6A 3B4
CanadaActive - Recruiting
Toronto Digestive Disease Associates
Vaughan, Ontario L4L 4Y7
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec H2X 0A9
CanadaSite Not Available
Poliklinika Borzan d.o.o.
Osijek, 31000
CroatiaSite Not Available
Clinical Hospital Center Rijeka
Rijeka, 51000
CroatiaSite Not Available
University Hospital Centre Sestre Milosrdnice
Zagreb, 10000
CroatiaSite Not Available
Nemocnice Ceske Budejovice, a.s.
Ceske Budejovice, 370 01
CzechiaSite Not Available
Fakultni Nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaSite Not Available
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, 500 12
CzechiaSite Not Available
IBD Clinical and Research centre
Prague, 190 00
CzechiaSite Not Available
Aalborg Hospital
Aalborg, 9000
DenmarkSite Not Available
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, 2650
DenmarkSite Not Available
CHU d'Amiens-Picardie - Hopital SUD
Amiens Cedex 01, 80054
FranceSite Not Available
Hopital Huriez - CHRU de Lille
Lille Cedex, 59037
FranceSite Not Available
Chu - Hopital Nord
Marseille Cedex 20, 13015
FranceSite Not Available
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, 44093
FranceSite Not Available
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, 33600
FranceSite Not Available
CHU St Etienne Hopital Nord
Saint Etienne, 42270
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
Toulouse cedex 09, 31059
FranceSite Not Available
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
Vandoeuvre les Nancy, 54511
FranceSite Not Available
Krankenhaus Waldfriede e.V.
Berlin, 14163
GermanySite Not Available
Agaplesion Markus Krankenhaus
Frankfurt Am Main, 60431
GermanySite Not Available
Studiengesellschaft BSF
Halle, 06108
GermanySite Not Available
Universitaetsklinikum Jena
Jena, 07747
GermanySite Not Available
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, 24105
GermanySite Not Available
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, 67065
GermanySite Not Available
Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
Mannheim, 68167
GermanySite Not Available
University of Athens School of Medicine, Alexandra General Hospital
Athens, Attiki 11528
GreeceSite Not Available
Metaxa Cancer Hospital
Piraeus, Attiki 185 37
GreeceSite Not Available
University Hospital of Heraklion
Heraklion, Crete 71110
GreeceSite Not Available
Central Hospital of Northern Pest - Military Hospital
Budapest, 1062
HungarySite Not Available
Semmelweis Egyetem
Budapest, 1082
HungarySite Not Available
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
Szeged, 6720
HungarySite Not Available
Adelaide, Meath and National Children's Hospital
Dublin, 24
IrelandSite Not Available
Beaumont Hospital
Dublin, D09 V2N0
IrelandSite Not Available
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
Dublin, D04 T6F4
IrelandSite Not Available
Soroka Medical Center
Be'er Sheva, 8410101
IsraelSite Not Available
Rambam Health Care Campus (RHCC)
Haifa, 3109601
IsraelSite Not Available
Meir Medical Center
Kfar-Saba, 44281
IsraelSite Not Available
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petach Tikva, 49100
IsraelSite Not Available
The Tel Aviv Sourasky Medical Center
Tel-Aviv, 6423906
IsraelSite Not Available
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
Milano, 20132
ItalySite Not Available
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, 80131
ItalySite Not Available
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 00168
ItalySite Not Available
Humanitas Clinical And Research Institute
Rozzano, 20089
ItalySite Not Available
Fondazione IRCSS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013
ItalySite Not Available
AO Ordine Mauriziano di Torino
Torino, 10122
ItalySite Not Available
Inje University Haeundae Paik Hospital
Busan, 48108
Korea, Republic ofActive - Recruiting
Yeungnam University Medical Center
Daegu, 42415
Korea, Republic ofSite Not Available
The Catholic University of Korea, Daejeon St.Mary's Hospital
Daejeon, 34943
Korea, Republic ofSite Not Available
Chung-Ang University Hospital
Seoul, 06973
Korea, Republic ofSite Not Available
Kyung Hee University Hospital
Seoul, 02447
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
The Catholic University Of Korea, St. Vincent's Hospital
Suwon-si, 16247
Korea, Republic ofSite Not Available
Amsterdam UMC Research BV
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Radboud University Medical Center
Nijmegen, 6525 GA
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, 3015 GD
NetherlandsSite Not Available
Elisabeth TweeSteden Ziekenhuis (ETZ)
Tilburg, 5022 GC
NetherlandsSite Not Available
Vestre Viken HF - Baerum Sykehus
Drammen, Gjettum 1309
NorwaySite Not Available
Haukeland Universitetssjukehus (Haukeland University Hospital)
Bergen, N5021
NorwaySite Not Available
Akershus University Hospital
Lorenskog, 1478
NorwaySite Not Available
Oslo Universitetssykehus HF, Ulleval
Oslo, 0424
NorwaySite Not Available
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
Poznan, 60-354
PolandSite Not Available
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, 43-100
PolandSite Not Available
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 05-401
PolandSite Not Available
Panstwowy Instytut Medyczny MSWiA
Warszawa, 02-507
PolandSite Not Available
Unidade Local de Saude Coimbra
Coimbra, 3000-075
PortugalSite Not Available
Centro Hospitalar Universitario Lisboa Norte EPE
Lisboa, 1649-028
PortugalSite Not Available
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
Lisbon, 1349-019
PortugalSite Not Available
University Clinical Centre - Ljubljana
Ljubljana, 1000
SloveniaSite Not Available
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007
SpainSite Not Available
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital Universitari Son Espases
Palma, 07120
SpainSite Not Available
Complejo Hospitalario de Navarra (CHN)
Pamplona, 31008
SpainSite Not Available
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, 15706
SpainSite Not Available
Hospital Universitari I Politecnic La Fe
Valencia, 46026
SpainSite Not Available
Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
Linkoping,
SwedenSite Not Available
Danderyds Sjukhus AB
Stockholm, 182 88
SwedenSite Not Available
Ersta sjukhus
Stockholm, 116 30
SwedenSite Not Available
Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
Stockholm, 171 76
SwedenSite Not Available
University Hospital Basel
Basel, 4031
SwitzerlandSite Not Available
University Hospital Bern (Inselspital)
Bern, 3010
SwitzerlandSite Not Available
Universitatsspital Zurich
Zurich, 8091
SwitzerlandSite Not Available
Zentrum fur Gastroenterologie
Zurich, 8048
SwitzerlandSite Not Available
Changhua Christian Hospital
Changhua City, 50006
TaiwanSite Not Available
Chung Shan Medical University Hospital
Taichung, 40201
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 70403
TaiwanSite Not Available
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
Taipei, 11490
TaiwanSite Not Available
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 33305
TaiwanSite Not Available
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, England SE1 7EH
United KingdomSite Not Available
The Royal London Hospital - Barts Health NHS Trust
London, Greater London E1 1BB
United KingdomSite Not Available
Western General Hospital
Edinburgh, Lothian EH4 2XU
United KingdomSite Not Available
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
Glasgow, Scotland G51 4TF
United KingdomSite Not Available
UCSD Medical Center
La Jolla, California 92037
United StatesSite Not Available
Keck Medicine Of USC - USC Healthcare Center 1
Los Angeles, California 90033
United StatesSite Not Available
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
GI PROS Research
Naples, Florida 34102
United StatesActive - Recruiting
GI PROS, Inc.
Naples, Florida 34102
United StatesSite Not Available
Orlando Health Ambulatory Care Center
Orlando, Florida 32806
United StatesSite Not Available
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesSite Not Available
Indiana University (IU) Health University Hospital
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Columbia University Medical Center, New York-Presbyterian Hospital
New York, New York 10032
United StatesSite Not Available
Lenox Hill Hospital Northwell Health
New York, New York 10075
United StatesSite Not Available
Lenox Hill Hospital-Northwell Health
New York, New York 10075
United StatesActive - Recruiting
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
New York, New York 10029-5204
United StatesSite Not Available
Gastroenterology Associates
Greenville, South Carolina 29607
United StatesSite Not Available
Rapid City Medical Center
Rapid City, South Dakota 57701
United StatesSite Not Available
Southern Star Research Institute
San Antonio, Texas 78229
United StatesActive - Recruiting
Southern Star Research Institute, LLC
San Antonio, Texas 78229
United StatesActive - Recruiting
Tyler Research Institute, LLC
Tyler, Texas 75701
United StatesActive - Recruiting
Swedish Cancer Institute
Seattle, Washington 98104
United StatesSite Not Available
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
Medical College of Wisconsin Cancer Center - Froedtert Hospital
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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