Clinical trial • Phase III • Gastroenterology

VEDOLIZUMAB for Crohn's disease

Phase III trial of VEDOLIZUMAB for Crohn's disease.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase III
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
05-11-2024
First CTIS Authorization Date
10-03-2025

Trial design

Randomised, arm a (investigational combination induction): vedolizumab (entyvio) 300 mg intravenous formulation (product: entyvio 300 mg powder for concentrate for solution for infusion) combined with oral upadacitinib (rinvoq) 45 mg prolonged-release tablets (over-encapsulated for blinding). arm b (comparator induction): vedolizumab (entyvio) 300 mg iv + oral placebo matching upadacitinib. maintenance: intravenous vedolizumab monotherapy. (doses shown where stated in product metadata: entyvio 300 mg; rinvoq 45 mg.)-controlled Phase III trial in Belgium, Slovenia, Spain and others.

Randomised
Yes
Comparator
Arm A (investigational combination induction): Vedolizumab (Entyvio) 300 mg intravenous formulation (product: Entyvio 300 mg powder for concentrate for solution for infusion) combined with oral Upadacitinib (RINVOQ) 45 mg prolonged-release tablets (over-encapsulated for blinding). Arm B (comparator induction): Vedolizumab (Entyvio) 300 mg IV + oral placebo matching Upadacitinib. Maintenance: intravenous Vedolizumab monotherapy. (Doses shown where stated in product metadata: Entyvio 300 mg; RINVOQ 45 mg.)
Target Sample Size
172
Trial Duration For Participant
364

Eligibility

Recruits 172 The CTIS record indicates isVulnerablePopulationSelected = true and multiple subject information and informed consent forms (SIS-ICF) and related documents are provided (including versions for pregnant partners and other specific subject-information documents). The record does not provide detailed text describing assent/consent handling for specific vulnerable groups; available materials list multiple ICF documents and language-specific versions but specific procedures (e.g., assent for minors, surrogate consent processes) are not detailed in the CTIS metadata..

Vulnerable Population
The CTIS record indicates isVulnerablePopulationSelected = true and multiple subject information and informed consent forms (SIS-ICF) and related documents are provided (including versions for pregnant partners and other specific subject-information documents). The record does not provide detailed text describing assent/consent handling for specific vulnerable groups; available materials list multiple ICF documents and language-specific versions but specific procedures (e.g., assent for minors, surrogate consent processes) are not detailed in the CTIS metadata.

Inclusion criteria

  • {"criterion_text":"- 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."}
  • {"criterion_text":"- The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450."}
  • {"criterion_text":"- The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), as confirmed by a central reader."}
  • {"criterion_text":"- The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy."}

Exclusion criteria

  • {"criterion_text":"- The participant has a current diagnosis of ulcerative colitis or indeterminate colitis."}
  • {"criterion_text":"- The participant has infection(s) requiring treatment with IV anti-infectives within 30 days before baseline or oral/intramuscular anti-infectives within 14 days before baseline."}
  • {"criterion_text":"- The participant has evidence of an active infection during the screening period, or clinically significant infection (for example, pneumonia or pyelonephritis) within 30 days prior to screening, or ongoing chronic infection."}
  • {"criterion_text":"- The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- The participant has an ostomy or ileoanal pouch."}
  • {"criterion_text":"- 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)."}
  • {"criterion_text":"- The participant has severe (Child-Pugh C) hepatic impairment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- CDAI-defined clinical remission at Week 12, defined as CDAI <150","definition_or_measurement_approach":"Clinical remission defined by Crohn's Disease Activity Index (CDAI) < 150 at Week 12."}
  • {"endpoint_text":"- Endoscopic response at Week 12, assessed as proportion of participants achieving decrease in Simple Endoscopic Score for Crohn’s Disease (SES CD) >50% from baseline (or for participants with isolated ileal disease, SES-CD ≤4 or ≤2-point reduction from baseline) read centrally.","definition_or_measurement_approach":"Endoscopic response assessed centrally as proportion achieving >50% reduction in SES‑CD from baseline (or, for isolated ileal disease, SES‑CD ≤4 or ≥2‑point reduction) at Week 12."}

Secondary endpoints

  • {"endpoint_text":"- PRO2-defined clinical remission at Week 12, defined as 7-day average of very soft or liquid stool frequency ≤2.8, 7-day average of abdominal pain score ≤1.0, and neither worse than baseline","definition_or_measurement_approach":"PRO2 clinical remission: 7‑day average of very soft/liquid stool frequency ≤2.8 and 7‑day average abdominal pain score ≤1.0, with neither worse than baseline, at Week 12."}
  • {"endpoint_text":"- a. CDAI-defined clinical remission at Week 52. b. Endoscopic response at Week 52. c. PRO2-defined clinical remission at Week 52.","definition_or_measurement_approach":"CDAI, SES‑CD and PRO2 outcomes assessed at Week 52 using the same definitions as for Week 12 (CDAI <150; SES‑CD response criteria; PRO2 criteria)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
172
Recruitment Window Months
41
Consent Approach
Informed consent is via study-specific Subject Information and Informed Consent Forms (SIS-ICF) and related subject information documents; multiple language versions and specific ICF modules are provided (including main ICF, pregnant partner information, optional genetic research and optional sub-study ICFs). The record indicates ICFs available in multiple languages (English and numerous country/language-specific versions such as French, Dutch, Spanish, Portuguese, German, Italian, Swedish, Polish, Czech, Hungarian, Greek, Slovene and others). Consent is provided by the adult participant (trial is in adults); specific assent procedures for minors are not described in the CTIS metadata.

Methods

  • Flyer/Poster (K2_Flyer-Poster) distributed to potential participants
  • Brochure / Study brochure materials (K2_Brochure) for participants/HCPs
  • Patient email campaigns (K2_Patient Email) - targeted email communications
  • HCP referral/email (K2_HCP Email) to healthcare professionals
  • Visit Guide and IC Flowchart materials to support recruitment and informed consent process (K2_Visit Guide, K2_IC Flowchart)
  • Trialbee digital recruitment campaign materials (Trialbee landing pages, digital marketing content and privacy policy) including online self-assessment and landing pages
  • Site recruitment procedures and ICF process documents (K1_Recruit-ICF process / K1_Patient Recruitment Procedure)
  • Scout/ScoutPass-related recruitment materials (where used, country-specific versions present in documentation)

Geography

Total Number Of Sites
92
Total Number Of Participants
224

Belgium

Earliest CTIS Part Ii Submission Date
10-02-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
291
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Hopital Erasme
Department Name
Gastroenterology
Principal Investigator Name
Denis Franchimont
Principal Investigator Email
denis.franchimont@hubruxelles.be
Contact Person Name
Denis Franchimont
Site Name
Imelda
Department Name
Gastroenterology
Principal Investigator Name
Lieven Pouillon
Principal Investigator Email
lieven.pouillon@imelda.be
Contact Person Name
Lieven Pouillon
Contact Person Email
lieven.pouillon@imelda.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology
Principal Investigator Name
Triana Lobaton Ortega
Principal Investigator Email
triana.lobatonortega@uzgent.be
Contact Person Name
Triana Lobaton Ortega
Contact Person Email
triana.lobatonortega@uzgent.be
Site Name
CHC MontLegia
Department Name
Gastroenterology
Principal Investigator Name
Arnaud Colard
Principal Investigator Email
arnaud.colard@chc.be
Contact Person Name
Arnaud Colard
Contact Person Email
arnaud.colard@chc.be
Site Name
UZ Leuven
Department Name
Internal Medicine
Principal Investigator Name
Marc Ferrante
Principal Investigator Email
marc.ferrante@uzleuven.be
Contact Person Name
Marc Ferrante
Contact Person Email
marc.ferrante@uzleuven.be

Slovenia

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
368
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
University Medical Center Ljubljana
Department Name
Gastroenterology Dept.
Principal Investigator Name
David Drobne
Principal Investigator Email
david.drobne@kclj.si
Contact Person Name
David Drobne
Contact Person Email
david.drobne@kclj.si

Spain

Earliest CTIS Part Ii Submission Date
19-02-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
285
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Digestive Medicine Service
Principal Investigator Name
Pilar Nos Mateu
Principal Investigator Email
nos_pil@gva.es
Contact Person Name
Pilar Nos Mateu
Contact Person Email
nos_pil@gva.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Inflammatory Bowel Disease Unit
Principal Investigator Name
Manuel Barreiro de Acosta
Principal Investigator Email
Manuel.Barreiro.de.Acosta@sergas.es
Contact Person Name
Manuel Barreiro de Acosta
Site Name
Hospital Universitario La Paz
Department Name
Gastroenterology
Principal Investigator Name
Maria Dolores Martin Arranz
Principal Investigator Email
mmartinarranz@salud.madrid.org
Contact Person Name
Maria Dolores Martin Arranz
Contact Person Email
mmartinarranz@salud.madrid.org
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Gastroenterology
Principal Investigator Name
Ignacio Marin Jimenez
Principal Investigator Email
Ensayosgastoentero.hgugm@gmail.com
Contact Person Name
Ignacio Marin Jimenez
Site Name
Hospital Universitario De Navarra
Department Name
Gastroenterology (inflammatory bowel disease section)
Principal Investigator Name
Cristina Rodriguez Gutiérrez
Principal Investigator Email
Cristina.rodriguez.gutierrez@navarra.es
Contact Person Name
Cristina Rodriguez Gutiérrez
Site Name
University Hospital Son Espases
Department Name
Digestive system service
Principal Investigator Name
Daniel Ginard Vicens
Principal Investigator Email
Daniel.ginard@ssib.es
Contact Person Name
Daniel Ginard Vicens
Contact Person Email
Daniel.ginard@ssib.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Digestive service
Principal Investigator Name
Federico Argüelles Arias
Principal Investigator Email
arguelles@telefonica.net
Contact Person Name
Federico Argüelles Arias
Contact Person Email
arguelles@telefonica.net

Norway

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
274
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Vestre Viken HF
Department Name
Gastroenterology
Principal Investigator Name
Stine Astrup Hvattum
Principal Investigator Email
sthvat@vestreviken.no
Contact Person Name
Stine Astrup Hvattum
Contact Person Email
sthvat@vestreviken.no
Site Name
Oslo University Hospital HF
Department Name
Gastorenterology
Principal Investigator Name
Marte Lie Høivik
Principal Investigator Email
moliho@ous-hf.no
Contact Person Name
Marte Lie Høivik
Contact Person Email
moliho@ous-hf.no
Site Name
Helse Bergen HF
Department Name
Gastroenterology
Principal Investigator Name
Kim Nylund
Principal Investigator Email
kim.nylund@helse-bergen.no
Contact Person Name
Kim Nylund
Contact Person Email
kim.nylund@helse-bergen.no
Site Name
Akershus University Hospital
Department Name
Gastroenterology
Principal Investigator Name
Stephan Andreas Brackmann
Principal Investigator Email
Stephan.Andreas.Brackmann@ahus.no
Contact Person Name
Stephan Andreas Brackmann

Czechia

Earliest CTIS Part Ii Submission Date
13-02-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
292
Number Of Sites
4
Number Of Participants
12

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
II. Interní gastroenterologická klinika
Principal Investigator Name
Tomáš Douda
Principal Investigator Email
tomas.douda@fnhk.cz
Contact Person Name
Tomáš Douda
Contact Person Email
tomas.douda@fnhk.cz
Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
Gastroenterologické oddělení
Principal Investigator Name
Martin Bortlík
Principal Investigator Email
bortlik.martin@nemcb.cz
Contact Person Name
Martin Bortlík
Contact Person Email
bortlik.martin@nemcb.cz
Site Name
Iscare a.s.
Department Name
IBD Clinical and Research Center
Principal Investigator Name
Milan Lukáš
Principal Investigator Email
milan.lukas@email.cz
Contact Person Name
Milan Lukáš
Contact Person Email
milan.lukas@email.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Principal Investigator Name
Tomáš Vaňásek
Principal Investigator Email
tomas.vanasek@hepato-gastro.com
Contact Person Name
Tomáš Vaňásek

Denmark

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
269
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Rigshospitalet
Department Name
Department of Digestive Diseases, Transplantation and General Surgery
Principal Investigator Name
Maria Axtoft Munk Pedersen
Principal Investigator Email
maria.axtoft.munk.pedersen@regionh.dk
Contact Person Name
Maria Axtoft Munk Pedersen
Site Name
Hvidovre Hospital
Department Name
Department of Gastroenterology
Principal Investigator Name
Gitte Pedersen
Principal Investigator Email
Gitte.Pedersen.01@regionh.dk
Contact Person Name
Gitte Pedersen
Contact Person Email
Gitte.Pedersen.01@regionh.dk
Site Name
Aalborg University Hospital
Department Name
Department of Medical Gastroenterology
Principal Investigator Name
Jan Fallingborg
Principal Investigator Email
jaf@rn.dk
Contact Person Name
Jan Fallingborg
Contact Person Email
jaf@rn.dk

Italy

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
04-12-2025
Processing Time Days
281
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Department of Clinical Medicine and Surgery
Principal Investigator Name
Fabiana Castiglione
Principal Investigator Email
fabcasti@unina.it
Contact Person Name
Fabiana Castiglione
Contact Person Email
fabcasti@unina.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Unità di Gastroenterologia
Principal Investigator Name
Edoardo Vincenzo Savarino
Principal Investigator Email
edoardo.savarino@unipd.it
Contact Person Name
Edoardo Vincenzo Savarino
Contact Person Email
edoardo.savarino@unipd.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Medicina Interna e Gastroenterologia
Principal Investigator Name
Antonio Gasbarrini
Principal Investigator Email
Antonio.gasbarrini@unicatt.it
Contact Person Name
Antonio Gasbarrini
Contact Person Email
Antonio.gasbarrini@unicatt.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
Gastroenterology Unit
Principal Investigator Name
Marco Daperno
Principal Investigator Email
mdaperno@gmail.com
Contact Person Name
Marco Daperno
Contact Person Email
mdaperno@gmail.com
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Gastroenterology and Endoscopy Unit
Principal Investigator Name
Silvio Danese
Principal Investigator Email
Danese.silvio@hrs.it
Contact Person Name
Silvio Danese
Contact Person Email
Danese.silvio@hrs.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
UOC Gastroenterologia, Policlinico Universitario Monserrato "Duilio Casula"
Principal Investigator Name
Massimo Claudio Fantini
Principal Investigator Email
massimoc.fantini@unica.it
Contact Person Name
Massimo Claudio Fantini
Contact Person Email
massimoc.fantini@unica.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
Unità Operativa Complessa di Endoscopia Digestiva
Principal Investigator Name
Fabrizio Bossa
Principal Investigator Email
f.bossa@operapadrepio.it
Contact Person Name
Fabrizio Bossa
Contact Person Email
f.bossa@operapadrepio.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Chronic Inflammatory Bowel Diseases Unit- IBD Center
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
alessandro.armuzzi@hunimed.eu
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu

Ireland

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
283
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
St Vincent's University Hospital
Department Name
Gastroenterology
Principal Investigator Name
Glen Doherty
Principal Investigator Email
g.doherty@st-vincents.ie
Contact Person Name
Glen Doherty
Contact Person Email
g.doherty@st-vincents.ie
Site Name
University Hospital Galway
Department Name
Gastroenterology
Principal Investigator Name
Mary Hussey
Principal Investigator Email
mary.hussey1@hse.ie
Contact Person Name
Mary Hussey
Contact Person Email
mary.hussey1@hse.ie
Site Name
Tallaght University Hospital
Department Name
Gastroenterology
Principal Investigator Name
Deirdre McNamara
Principal Investigator Email
info@tuhf.ie
Contact Person Name
Deirdre McNamara
Contact Person Email
info@tuhf.ie
Site Name
Beaumont Hospital
Department Name
Gastroenterology
Principal Investigator Name
Aoibhlinn O’Toole
Principal Investigator Email
aoibhlinnmaryotoole@beaumont.ie
Contact Person Name
Aoibhlinn O’Toole

Poland

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
30-11-2025
Processing Time Days
277
Number Of Sites
7
Number Of Participants
15

Sites

Site Name
Klinika Reuma Park Sp. z o.o. S.K.
Department Name
Centrum Medyczne Reuma Park
Principal Investigator Name
Andrzej Bielasik
Principal Investigator Email
info@reumatika.pl
Contact Person Name
Andrzej Bielasik
Contact Person Email
info@reumatika.pl
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkus
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Department Name
Państwowy Instytut Medyczny Klinika Gastroenterologii i Chorób Wewnętrznych
Principal Investigator Name
Grażyna Rydzewska-Wyszkowska
Principal Investigator Email
gastroenterologia@cskmswia.gov.pl
Contact Person Name
Grażyna Rydzewska-Wyszkowska
Site Name
H-T.Centrum Medyczne Sp. z o.o. sp.k.
Department Name
H-T. Centrum Medyczne - Endoterapia
Principal Investigator Name
Tomasz Romańczyk
Principal Investigator Email
romanczyk@htcentrum.pl
Contact Person Name
Tomasz Romańczyk
Contact Person Email
romanczyk@htcentrum.pl
Site Name
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
Department Name
Poradnia Internistyczna
Principal Investigator Name
Piotr Eder
Principal Investigator Email
ucwbk@ump.edu.pl
Contact Person Name
Piotr Eder
Contact Person Email
ucwbk@ump.edu.pl
Site Name
Centrum Medyczne Plejady
Department Name
Centrum Medyczne Plejady
Principal Investigator Name
Monika Augustyn
Principal Investigator Email
trials@plejady.com.pl
Contact Person Name
Monika Augustyn
Contact Person Email
trials@plejady.com.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej
Principal Investigator Name
Ewa Małecka-Wojciesko
Principal Investigator Email
ewa.malecka-panas@umed.lodz.pl
Contact Person Name
Ewa Małecka-Wojciesko
Contact Person Email
ewa.malecka-panas@umed.lodz.pl

Croatia

Earliest CTIS Part Ii Submission Date
04-03-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
273
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Poliklinika Borzan d.o.o.
Principal Investigator Name
Vladimir Borzan
Principal Investigator Email
vborzan@hotmail.com
Contact Person Name
Vladimir Borzan
Contact Person Email
vborzan@hotmail.com
Site Name
Clinical Hospital Centre Rijeka
Department Name
Zavod za gastroenterologiju
Principal Investigator Name
Irena Krznarić Zrnić
Principal Investigator Email
ikrznariczrnic@yahoo.lco.uk
Contact Person Name
Irena Krznarić Zrnić
Contact Person Email
ikrznariczrnic@yahoo.lco.uk
Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
Zavod za gastroenterologiju i hepatologiju
Principal Investigator Name
Alen Bišćanin
Principal Investigator Email
alen.biscanin@gmail.com
Contact Person Name
Alen Bišćanin
Contact Person Email
alen.biscanin@gmail.com

Sweden

Earliest CTIS Part Ii Submission Date
13-02-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
288
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Ersta Sjukhus-Ersta Hospital
Department Name
Gastroenterology
Principal Investigator Name
Per-Johan Lindfors
Principal Investigator Email
per-johan.lindfors@erstadiakoni.se
Contact Person Name
Per-Johan Lindfors
Site Name
Region Oestergoetland
Department Name
Gastroenterology
Principal Investigator Name
Henrik Hjortswang
Principal Investigator Email
henrik.hjortswang@regionostergotland.se
Contact Person Name
Henrik Hjortswang
Site Name
Danderyds Sjukhus AB
Department Name
Gastorenterology
Principal Investigator Name
Mikael Lördal
Principal Investigator Email
Mikael.lordal@regionstockholm.se
Contact Person Name
Mikael Lördal
Site Name
Karolinska University Hospital
Department Name
Centre for Digestive Health
Principal Investigator Name
Charlotte Hedin
Principal Investigator Email
charlotte.hedin@ki.se
Contact Person Name
Charlotte Hedin
Contact Person Email
charlotte.hedin@ki.se

Austria

Earliest CTIS Part Ii Submission Date
08-01-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
327
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Medical University Of Vienna
Department Name
University Clinic for Internal Medicine III
Principal Investigator Name
Walter Reinisch
Principal Investigator Email
walter.reinisch@meduniwien.ac.at
Contact Person Name
Walter Reinisch
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Internal Medicine I
Principal Investigator Name
Sonja Heeren
Principal Investigator Email
s.heeren@salk.at
Contact Person Name
Sonja Heeren
Contact Person Email
s.heeren@salk.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Med Campus III General Hospital of the City of Linz (AKH)
Principal Investigator Name
Alexander Moschen
Principal Investigator Email
Alexander.Moschen@kepleruniklinikum.at
Contact Person Name
Alexander Moschen
Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Department of Internal Medicine I
Principal Investigator Name
Alexander Eser
Principal Investigator Email
aesere@live.com
Contact Person Name
Alexander Eser
Contact Person Email
aesere@live.com
Site Name
Medizinische Universitaet Innsbruck
Department Name
University Clinic for Internal Medicine II
Principal Investigator Name
Robert Koch
Principal Investigator Email
Robert.koch@i-med.ac.at
Contact Person Name
Robert Koch
Contact Person Email
Robert.koch@i-med.ac.at

Germany

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
284
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Department Name
-
Principal Investigator Name
Lars Fechner
Principal Investigator Email
dr.fechner@gastro-halle.de
Contact Person Name
Lars Fechner
Contact Person Email
dr.fechner@gastro-halle.de
Site Name
St. Marien Und St. Annastiftskrankenhaus
Department Name
Klinik für Innere Medizin
Principal Investigator Name
Tanja Kühbacher
Principal Investigator Email
studienabteilung@st-marienkrankenhaus.de
Contact Person Name
Tanja Kühbacher
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin IV (Gastroenterologie, Hepatologie,Infektiologie, Zentrale Endoskopie)
Principal Investigator Name
Andreas Stallmach
Principal Investigator Email
andreas.stallmach@med.uni-jena.de
Contact Person Name
Andreas Stallmach
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Medizinische Klinik I
Principal Investigator Name
Axel Dignass
Principal Investigator Email
med1.mk.fdk@agaplesion.de
Contact Person Name
Axel Dignass
Contact Person Email
med1.mk.fdk@agaplesion.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klink für Innere Medizin I
Principal Investigator Name
Stefan Schreiber
Principal Investigator Email
stefan.schreiber@uksh.de
Contact Person Name
Stefan Schreiber
Contact Person Email
stefan.schreiber@uksh.de
Site Name
Heidelberg University
Department Name
II. Medizinische Klinik
Principal Investigator Name
Wolfgang Reindl
Principal Investigator Email
wolfgang.reindl@umm.de
Contact Person Name
Wolfgang Reindl
Contact Person Email
wolfgang.reindl@umm.de
Site Name
Krankenhaus Waldfriede e.V.
Department Name
Akademisches Lehrkrankenhaus Innere Abteilung
Principal Investigator Name
Carsten Büning
Principal Investigator Email
c.buening@waldfriede.de
Contact Person Name
Carsten Büning
Contact Person Email
c.buening@waldfriede.de

Portugal

Earliest CTIS Part Ii Submission Date
30-01-2025
Latest Decision Or Authorization Date
28-11-2025
Processing Time Days
302
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
María Helena Pereira Tavares de Sousa
Principal Investigator Email
helenatsousa@gmail.com
Contact Person Name
María Helena Pereira Tavares de Sousa
Contact Person Email
helenatsousa@gmail.com
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Francisco Portela
Principal Investigator Email
17524@ulscoimbra.min-saude.pt
Contact Person Name
Francisco Portela
Contact Person Email
17524@ulscoimbra.min-saude.pt
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Gastroenterology
Principal Investigator Name
Joana María Tinoco Da Silva Torres
Principal Investigator Email
joana.torres@ulslod.min-saude.pt
Contact Person Name
Joana María Tinoco Da Silva Torres
Site Name
Unidade Local De Saude De Gaia/Espinho E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Joao Carlos Baranda Moreira Da Silva Ribeiro
Principal Investigator Email
joao.rocha.silva@ulsge.min-saude.pt
Contact Person Name
Joao Carlos Baranda Moreira Da Silva Ribeiro
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Sofia Saraiva
Principal Investigator Email
celia.francisco@chln.min-saude.pt
Contact Person Name
Sofia Saraiva
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Tiago Pereira Guedes
Principal Investigator Email
tiagoguedes.gastro@ulssa.min-saude.pt
Contact Person Name
Tiago Pereira Guedes
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
Gastroenterology
Principal Investigator Name
Tiago Bana e Costa
Principal Investigator Email
ammoreira@ulslo.min-saude.pt
Contact Person Name
Tiago Bana e Costa
Contact Person Email
ammoreira@ulslo.min-saude.pt

Hungary

Earliest CTIS Part Ii Submission Date
28-02-2025
Latest Decision Or Authorization Date
01-12-2025
Processing Time Days
276
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Gastroenterológiai Osztály
Principal Investigator Name
Tibor Gyökeres
Principal Investigator Email
gyokereshonvedstudy@gmail.com
Contact Person Name
Tibor Gyökeres
Contact Person Email
gyokereshonvedstudy@gmail.com
Site Name
Semmelweis University
Department Name
Sebészeti, Transzplantációs és Gasztroenterológiai Klinika
Principal Investigator Name
Pál Miheller
Principal Investigator Email
miheller.pal@semmelweis.hu
Contact Person Name
Pál Miheller
Contact Person Email
miheller.pal@semmelweis.hu
Site Name
University Of Szeged
Department Name
Szent-Györgyi Albert Klinikai Központ, Belgyógyászati Klinika, Gasztroenterológiai Osztály
Principal Investigator Name
Tamás Molnár
Principal Investigator Email
molnar.tamas@med.u-szeged.hu
Contact Person Name
Tamás Molnár
Contact Person Email
molnar.tamas@med.u-szeged.hu

Greece

Earliest CTIS Part Ii Submission Date
28-11-2024
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
369
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Metaxa Cancer Center Hospital Of Piraeus
Department Name
Gastroenterology Department
Principal Investigator Name
Eftychia Tsironi
Principal Investigator Email
etsironi@yahoo.com
Contact Person Name
Eftychia Tsironi
Contact Person Email
etsironi@yahoo.com
Site Name
Alexandra Hospital
Department Name
Gastroenterology Department
Principal Investigator Name
Evanthia Zampeli
Principal Investigator Email
evazamb@gmail.com
Contact Person Name
Evanthia Zampeli
Contact Person Email
evazamb@gmail.com
Site Name
Hippokration Hospital
Department Name
Second Propedeutic Department of Internal Medicine
Principal Investigator Name
Olga Giouleme
Principal Investigator Email
giouleme@auth.gr
Contact Person Name
Olga Giouleme
Contact Person Email
giouleme@auth.gr
Site Name
Evaggelismos Hospital
Department Name
Gastroenterology Department
Principal Investigator Name
Nikolaos Viazis
Principal Investigator Email
nikos.viazis@gmail.com
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
GI Unit – 3rd Academic Department of Internal Medicine
Principal Investigator Name
Georgios Bamias
Principal Investigator Email
gbamias@gmail.com
Contact Person Name
Georgios Bamias
Contact Person Email
gbamias@gmail.com
Site Name
University General Hospital Of Heraklion
Department Name
Gastroenterology Department
Principal Investigator Name
Ioannis Koutroubakis
Principal Investigator Email
ikoutroub2@gmail.com
Contact Person Name
Ioannis Koutroubakis
Contact Person Email
ikoutroub2@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
03-03-2025
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
274
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Marjolijn Duijvestein
Principal Investigator Email
marjolijn.duijvestein@radboudumc.nl
Contact Person Name
Marjolijn Duijvestein
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Gastroenterology and hepatology
Principal Investigator Name
Pieter Maljaars
Principal Investigator Email
polimdl@lumc.nl
Contact Person Name
Pieter Maljaars
Contact Person Email
polimdl@lumc.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Gastroenterology and hepatology
Principal Investigator Name
Marieke Pierik
Principal Investigator Email
patientenservice@mumc.nl
Contact Person Name
Marieke Pierik
Contact Person Email
patientenservice@mumc.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Annemarie De Vries
Principal Investigator Email
a.c.devries@erasmusmc.nl
Contact Person Name
Annemarie De Vries
Contact Person Email
a.c.devries@erasmusmc.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Maurice Lutgens
Principal Investigator Email
m.lutgens@etz.nl
Contact Person Name
Maurice Lutgens
Contact Person Email
m.lutgens@etz.nl
Site Name
Amsterdam UMC Stichting
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Mark Löwenberg
Principal Investigator Email
m.lowenberg@amsterdamumc.nl
Contact Person Name
Mark Löwenberg
Contact Person Email
m.lowenberg@amsterdamumc.nl

France

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
27-11-2025
Processing Time Days
274
Number Of Sites
8
Number Of Participants
24

Sites

Site Name
CHRU De Nancy
Department Name
Gastroenterology- Clinical investigation unit
Principal Investigator Name
Bénédicte Caron
Principal Investigator Email
b.caron@chru-nancy.fr
Contact Person Name
Bénédicte Caron
Contact Person Email
b.caron@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastroenterology
Principal Investigator Name
Cyrielle Gilletta De Saint Joseph
Principal Investigator Email
gilletta.c@chu-toulouse.fr
Contact Person Name
Cyrielle Gilletta De Saint Joseph
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Gastroenterology
Principal Investigator Name
Michael Collins
Principal Investigator Email
michael.collins@chu-nantes.fr
Contact Person Name
Michael Collins
Contact Person Email
michael.collins@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hepato-Gastroenterology and digestive oncology, CMC Magellan
Principal Investigator Name
David Laharie
Principal Investigator Email
david.laharie@chu-bordeaux.fr
Contact Person Name
David Laharie
Contact Person Email
david.laharie@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Digestive system disease department
Principal Investigator Name
Maria Nachury
Principal Investigator Email
maria.nachury@chru-lille.fr
Contact Person Name
Maria Nachury
Contact Person Email
maria.nachury@chru-lille.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Mélanie Serrero
Principal Investigator Email
melanie.serrero@ap-hm.fr
Contact Person Name
Mélanie Serrero
Contact Person Email
melanie.serrero@ap-hm.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hepato-Gastroenterology
Principal Investigator Name
Mathurin Fumery
Principal Investigator Email
fumery.mathurin@chu-amiens.fr
Contact Person Name
Mathurin Fumery
Contact Person Email
fumery.mathurin@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroenterology
Principal Investigator Name
Xavier Roblin
Principal Investigator Email
gastro.mici.secretariat@chu-st-etienne.fr
Contact Person Name
Xavier Roblin

Sponsor

Primary sponsor

Full Name
Takeda Development Center Americas Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: ["1","12","13","2","5","6"] (as listed in CTIS record). Contact: Sjoerd.Balk@iconplc.com
Name
PRA Hellas CRO A.E.
Responsibilities
sponsorDuties include codes and '24hr Emergency contact for subjects' (as listed). Contact: ICONGreekAffiliateMailbox@iconplc.com

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [\"1\",\"12\",\"13\",\"2\",\"5\",\"6\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"IP procurement, over encapsulation, testing and supply.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Matthews Media Group Inc.","duties_or_roles":"Patient Recruitment & Retention vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA- Patient Reported Outcomes vendor","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Imaging- iledocolonoscopy & Intestinal Ultrasound","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties codes: [\"1\",\"12\",\"15\",\"2\",\"8\"] and value: \"24hr Emergency contact for subjects\"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Entyvio 300 mg powder for concentrate for solution for infusion
Active Substance
VEDOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation present (EU/1/14/923/001)
Maximum Dose
300 mg
Investigational Product Name
RINVOQ 45 mg prolonged-release tablets
Active Substance
UPADACITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation present (EU/1/19/1404/011)
Maximum Dose
45 mg (max daily dose amount as listed)
Investigational Product Name
Placebo to Match Blinded Upadacitinib
Modality
Other
Combination Treatment
Yes

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