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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
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

Full criteria on ClinicalTrials.gov

Sites (153)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaNot yet recruiting
Kepler Universitaetsklinikum GmbH
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LinzAustriaNot yet recruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
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SalzburgAustriaNot yet recruiting
Medical University of Vienna
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ViennaAustriaNot yet recruiting
Krankenhaus Der Barmherzigen Brueder Wien
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ViennaAustriaNot yet recruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
Imelda
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BonheidenBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
CHC MontLégia
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LiègeBelgiumRecruiting
Faculdade de Medicina de Botucatu
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BotucatuBrazilNot yet recruiting
Hospital Universitario Cajuru
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CuritibaBrazilNot yet recruiting
Centro de Estudos Clinico do Interior Paulista - CECIP
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JaúBrazilNot yet recruiting
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
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Rio de JaneiroBrazilNot yet recruiting
Pesquisare Saude
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Santo AndréBrazilNot 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 PauloBrazilNot 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 PauloBrazilNot yet recruiting
Barrie GI Associates
Coordinator of this site? Confirm its status
BarrieCanadaRecruiting
Heritage Medical Research Clinic - University Of Calgary
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CalgaryCanadaActive, not recruiting
Dalhousie University
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HalifaxCanadaNot yet recruiting
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
Coordinator of this site? Confirm its status
HamiltonCanadaActive, not recruiting
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaNot yet recruiting
Taunton Surgical Centre-Oshawa Clinic
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OshawaCanadaRecruiting
Toronto Immune and Digestive Health Institute (TIDHI)
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TorontoCanadaRecruiting
Toronto Digestive Disease Associates
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VaughanCanadaNot yet recruiting
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
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WinnipegCanadaNot yet recruiting
University Hospital Basel
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BaselSwitzerlandNot yet recruiting
University Hospital Bern / Inselspital
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BernSwitzerlandNot yet recruiting
Zentrum fur Gastroenterologie
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ZurichSwitzerlandNot yet recruiting
Universitätsspital Zürich
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ZurichSwitzerlandNot yet recruiting
Nemocnice České Budějovice, a.s.
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České BudějoviceCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
Hepato-Gastroenterologie HK, s.r.o.
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Hradec KrálovéCzechiaRecruiting
ISCARE a.s.
Coordinator of this site? Confirm its status
PragueCzechiaRecruiting
Krankenhaus Waldfriede e.V.
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting
Agaplesion Frankfurter Diakonie Kliniken gGmbH
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Frankfurt am MainGermanyRecruiting
Studiengesellschaft BSF UG (haftungsbeschraenkt)
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Halle (Saale)GermanyRecruiting
Universitaetsklinikum Jena KöR
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JenaGermanyRecruiting
Universitaetsklinikum Schleswig-Holstein AöR
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KielGermanyRecruiting
St. Marien und St. Annastiftskrankenhaus
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Ludwigshafen am RheinGermanyRecruiting
Heidelberg University
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MannheimGermanyRecruiting
Rigshospitalet
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Copenhagen OeDenmarkRecruiting
Region Nordjylland
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GistrupDenmarkRecruiting
Hvidovre Hospital
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HvidovreDenmarkRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
University Hospital Son Espases
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PalmaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire Amiens Picardie
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Amiens Cedex 1FranceRecruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
CHRU De Nancy
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Nancy CedexFranceRecruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceRecruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceRecruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Western General Hospital
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EdinburghUnited KingdomNot yet recruiting
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
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GlasgowUnited KingdomNot yet recruiting
The Royal London Hospital - Barts Health Nhs Trust
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LondonUnited KingdomNot yet recruiting
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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LondonUnited KingdomNot yet recruiting
Alexandra Hospital
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AthensGreeceRecruiting
Evaggelismos Hospital
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AthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
University General Hospital of Heraklion
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HeraklionGreeceRecruiting
Metaxa Cancer Center Hospital Of Piraeus
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PireasGreeceRecruiting
Hippokration Hospital
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ThessalonikiGreeceRecruiting
Klinicki bolnicki centar Sestre milosrdnice
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Grad ZagrebCroatiaRecruiting
Poliklinika Borzan d.o.o.
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OsijekCroatiaRecruiting
Clinical Hospital Centre Rijeka
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RijekaCroatiaRecruiting
Semmelweis University
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BudapestHungaryRecruiting
Central Hospital Of Northern Pest Military Hospital
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Budapest VIHungaryRecruiting
University of Szeged
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SzegedHungaryRecruiting
Tallaght University Hospital
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Dublin 24IrelandRecruiting
St Vincent's University Hospital
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Dublin 4IrelandRecruiting
Beaumont Hospital
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Dublin 9IrelandRecruiting
University Hospital Galway
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GalwayIrelandRecruiting
Soroka Medical Center
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BeershebaIsraelNot yet recruiting
Rambam Health Care Campus (RHCC)
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HaifaIsraelNot yet recruiting
Meir Medical Center
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Kfar SabaIsraelNot yet recruiting
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Coordinator of this site? Confirm its status
Petah TikvaIsraelNot yet recruiting
The Tel Aviv Sourasky Medical Center
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Tel AvivIsraelNot yet recruiting
Azienda Ospedaliero - Universitaria di Cagliari
Coordinator of this site? Confirm its status
CagliariItalyRecruiting
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliera di Padova
Coordinator of this site? Confirm its status
PadovaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Humanitas Mirasole S.p.A.
Coordinator of this site? Confirm its status
RozzanoItalyRecruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di Torino
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TurinItalyRecruiting
Inje University Haeundae Paik Hospital
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BusanSouth KoreaRecruiting
Yeungnam University Medical Center
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DaeguSouth KoreaActive, not recruiting
The Catholic University of Korea, Daejeon ST.Mary's Hospital
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DaejeonSouth KoreaActive, not recruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaActive, not recruiting
Chung ang University Hospital
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SeoulSouth KoreaActive, not recruiting
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaActive, not recruiting
Kyung Hee University Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaActive, not recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsNot yet recruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsNot yet recruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsNot yet recruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsNot yet recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsNot yet recruiting
Stichting Elisabeth-TweeSteden Ziekenhuis
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TilburgNetherlandsNot yet recruiting
Helse Bergen HF
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BergenNorwayRecruiting
Vestre Viken HF
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GjettumNorwayRecruiting
Akershus University Hospital
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LorenskogNorwayRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
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CracowPolandNot yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
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LodzPolandNot yet recruiting
Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.
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PoznanPolandNot yet recruiting
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
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TychyPolandNot yet recruiting
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
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WarsawPolandNot yet recruiting
Klinika Reuma Park Sp. z o.o. S.K.
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WarsawPolandNot yet recruiting
Medical Network Sp z o o
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WarsawPolandNot yet recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalRecruiting
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Coordinator of this site? Confirm its status
LisbonPortugalRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Unidade Local De Saude De Loures-Odivelas EPE
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LouresPortugalRecruiting
Unidade Local de Saude do Algarve E.P.E.
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PortimaoPortugalRecruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
Danderyds Sjukhus AB
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DanderydSwedenRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Ersta Sjukhus-Ersta Hospital
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StockholmSwedenRecruiting
University Medical Center Ljubljana
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LjubljanaSloveniaRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanNot yet recruiting
Taichung Veterans General Hospital
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TaichungTaiwanNot yet recruiting
Chung Shan Medical University Hospital
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TaichungTaiwanNot yet recruiting
National Cheng Kung University Hospital
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TainanTaiwanNot yet recruiting
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
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TaipeiTaiwanNot yet recruiting
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
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Taoyuan CityTaiwanNot yet recruiting
Peak Gastroenterology Associates
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Colorado SpringsUnited StatesRecruiting
Gastroenterology Associates
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GreenvilleUnited StatesActive, not recruiting
Indiana University (IU) Health University Hospital
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IndianapolisUnited StatesActive, not recruiting
UCSD Medical Center
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La JollaUnited StatesNot yet recruiting
University of Kentucky
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LexingtonUnited StatesActive, not recruiting
Keck Medicine Of USC - USC Healthcare Center 1
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Los AngelesUnited StatesNot yet recruiting
Medical College of Wisconsin Cancer Center - Froedtert Hospital
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MilwaukeeUnited StatesNot yet recruiting
GI PROS, Inc.
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NaplesUnited StatesActive, not recruiting
Columbia University Medical Center/New York-Presbyterian Hospital
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New YorkUnited StatesNot yet recruiting
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
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New YorkUnited StatesActive, not recruiting
Lenox Hill Hospital | Northwell Health
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New YorkUnited StatesActive, not recruiting
Orlando Health Ambulatory Care Center
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OrlandoUnited StatesActive, not recruiting
Rapid City Medical Center
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Rapid CityUnited StatesActive, not recruiting
Southern Star Research Institute, LLC
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San AntonioUnited StatesRecruiting
Swedish Cancer Institute
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SeattleUnited StatesNot yet recruiting
University of Washington Medical Center - Montlake
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SeattleUnited StatesNot yet recruiting
Virginia Mason Medical Center
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SeattleUnited StatesActive, not recruiting
USF Health Morsani Center for Advanced Healthcare
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TampaUnited StatesActive, not recruiting
Tyler Research Institute, LLC
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TylerUnited StatesRecruiting

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