Clinical trial • Phase II • Gastroenterology

Risankizumab for Crohn's disease

Phase II trial of Risankizumab for Crohn's disease. Randomised. 500 participants.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Crohn's disease
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
17-07-2024
First CTIS Authorization Date
11-11-2024

Trial design

Randomised Phase II trial in Latvia, Ireland, Finland and others.

Randomised
Yes
Target Sample Size
500

Eligibility

Recruits 500 No vulnerable population selected; participants are adults (18 to ≤75 years) and must meet the legal age of majority per local law. Informed consent is obtained from the adult participant. No assent procedures for minors are mentioned in the provided documents..

Vulnerable Population
No vulnerable population selected; participants are adults (18 to ≤75 years) and must meet the legal age of majority per local law. Informed consent is obtained from the adult participant. No assent procedures for minors are mentioned in the provided documents.

Inclusion criteria

  • {"criterion_text":"- Adults 18 to ≤ 75 years old (subjects must also meet the legal age of majority per local law).\n- Subjects' body weight must be ≥ 40 kg at Baseline.\n- Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.\n- CDAI ≥ 220 at Baseline.\n- Endoscopic evidence of mucosal inflammation as documented by an SES-CD of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.\n- Subjects must demonstrate intolerance or inadequate response to 1 or more of the following categories of drugs: oral locally acting steroids, systemic steroids (prednisone or equivalent), immunomodulators, and/or TaTs including biologics (e.g., infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or biosimilars) and/or small molecules, e.g., upadacitinib, and/or inadequate response to p19 inhibitors (anti-IL-23 mAbs). For Denmark only: Subjects must demonstrate intolerance or inadequate response to TATs"}

Exclusion criteria

  • {"criterion_text":"- Subjects who demonstrated intolerance to p19 inhibitors, including risankizumab.\n- Subject who received: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, including biosimilars within 8 weeks prior to Baseline, or ustekinumab (including biosimilars), risankizumab within 12 weeks prior to Baseline, or upadacitinib within 2 weeks prior to Baseline,any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification/quantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.\n- Subject who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as::abscess (abdominal or perianal); symptomatic bowel strictures; > 2 resected segments of the following 5 segments: terminal ileum, right colon, transverse colon, left colon and sigmoid, and rectum; previous small bowel resection with combined resected length of > 100 centimeters; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study;Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Achievement of endoscopic remission at Week 12.","definition_or_measurement_approach":"Assessed by endoscopy at Week 12."}

Secondary endpoints

  • {"endpoint_text":"- Clinical remission per Crohn's disease activity index (CDAI) at Week 12.","definition_or_measurement_approach":"Measured using the Crohn's Disease Activity Index (CDAI) at Week 12."}
  • {"endpoint_text":"- Clinical remission per stool frequency (SF)/abdominal pain score (APS) at Week 12.","definition_or_measurement_approach":"Measured using stool frequency and abdominal pain score (SF/APS) assessments at Week 12."}
  • {"endpoint_text":"- Endoscopic response at Week 12.","definition_or_measurement_approach":"Assessed by endoscopy at Week 12."}

Recruitment

Registry Or Advocacy Recruitment
True, Asociatia Oncohelp
Planned Sample Size
500
Recruitment Window Months
43
Consent Approach
Informed consent is obtained from each participant who is a legal adult per local law; participants must meet the legal age of majority. Country-specific subject information and informed consent forms (ICFs) are provided; ICFs and participant information are available in local country languages and English (examples in the document list include Latvian, Russian, English, German, French, Dutch, Polish, Romanian, Spanish, Italian, Portuguese, Finnish, Bulgarian, Czech, Estonian, Hungarian, Croatian, Slovak, Lithuanian, Slovenian, among others). Optional/pregnancy-related ICFs are included for specific countries where applicable.

Geography

Total Number Of Sites
143
Total Number Of Participants
572

Latvia

Earliest CTIS Part Ii Submission Date
29-10-2024
Latest Decision Or Authorization Date
14-11-2024
Processing Time Days
16
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Pauls Stradins Clinical University Hospital
Department Name
Center of Gastroenterology Hepatology and Nutrition
Contact Person Name
Aldis Pukitis
Contact Person Email
pukitis@latnet.lv
Site Name
Digestive Diseases Centre Gastro SIA
Department Name
Gastroenterology Department
Contact Person Name
Diana Lisova
Contact Person Email
diana.lisova@inbox.lv
Site Name
Liepajas Regionala Slimnica SIA
Department Name
Outpatient department
Contact Person Name
Linda Erne
Contact Person Email
liepaajaa@inbox.lv

Ireland

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
15-11-2024
Processing Time Days
24
Number Of Sites
7
Number Of Participants
32

Sites

Site Name
St Vincent's University Hospital
Department Name
Gastroenterology
Contact Person Name
Glen Doherty
Contact Person Email
gdoherty@svhg.ie
Site Name
Beaumont Hospital
Department Name
Gastroenterology
Contact Person Name
Karen Boland
Contact Person Email
karenboland2@beaumont.ie
Site Name
Connolly Hospital
Department Name
Gastroenterology
Contact Person Name
Orlaith Kelly
Contact Person Email
orlaith.kelly4@hse.ie
Site Name
Our Lady Of Lourdes Hospital
Department Name
Gastroenterology
Contact Person Name
John Keohane
Contact Person Email
john.keohane@hse.ie
Site Name
Letterkenny University Hospital
Department Name
Gastroenterology
Contact Person Name
Chris Steele
Contact Person Email
elisma.wilken@hse.ie
Site Name
Portiuncula University Hospital
Department Name
Gastroenterology
Contact Person Name
Gerard Clarke
Contact Person Email
gerard.clarke@hse.ie
Site Name
Regional Hospital Mullingar
Department Name
Gastroenterology
Contact Person Name
Murat Kirca
Contact Person Email
mkirca@crp.healthcare

Finland

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
31
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Turku University Hospital
Department Name
Gastroenterology Department
Contact Person Name
Jukka Koffert
Contact Person Email
jukka.koffert@varha.fi
Site Name
Tampere University Hospital
Department Name
Gastroenterology Department
Contact Person Name
Elina Jokinen
Contact Person Email
elina.jokinen@pirha.fi

Netherlands

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
14-11-2024
Processing Time Days
34
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Academisch Medisch Centrum
Department Name
MDL
Contact Person Name
Mark Lowenberg
Contact Person Email
m.lowenberg@amc.uva.nl
Site Name
Stichting Elisabeth-Tweesteden Ziekenhuis
Department Name
MDL
Contact Person Name
Maurice Lutgens
Contact Person Email
m.lutgens@etz.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
MDL
Contact Person Name
Henrica Fidder
Contact Person Email
h.h.fidder@umcutrecht.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
MDL
Contact Person Name
Gerard Dijkstra
Contact Person Email
gerard.dijkstra@umcg.nl

Romania

Earliest CTIS Part Ii Submission Date
09-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
40
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Gastroenterology
Contact Person Name
Bogdan Mateescu
Contact Person Email
bogmateescu@gmail.com
Site Name
Memorial Healthcare International S.R.L.
Department Name
Gastroenterology
Contact Person Name
Eugeniu Craciun
Contact Person Email
eugencraciun@yahoo.com
Site Name
Gastro Med S.R.L.
Department Name
Gastroenterology
Contact Person Name
Andrada Seicean
Contact Person Email
contact@clinica-gastromed.ro
Site Name
Asociatia Oncohelp
Department Name
Gastroenterology
Contact Person Name
Razvan Diaconescu
Contact Person Email
office@oncohelp.ro

Slovakia

Earliest CTIS Part Ii Submission Date
13-10-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
30
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
KM Management spol. s r.o.
Department Name
Gastroenterologicka ambulancia
Contact Person Name
Milos Gregus
Contact Person Email
gregus.studie@gmail.com
Site Name
Gastro I s.r.o.
Department Name
Gastroenterologicka ambulancia
Contact Person Name
Bohus Bunganic
Contact Person Email
gastrobunganic@gmail.com
Site Name
Endomed s.r.o.
Department Name
Gastroenterologicka ambulancia
Contact Person Name
Miroslav Fedurco
Contact Person Email
fedurco@endomed.sk
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Gastroenterologicka ambulancia
Contact Person Name
Michal Bruncak
Contact Person Email
michalbruncak@gmail.com

France

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
19-12-2024
Processing Time Days
83
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Hospices Civils De Lyon
Department Name
Gastroenterology
Contact Person Name
Stéphane Nancey
Contact Person Email
Stephane.nancey@chu-lyon.fr
Site Name
CHRU De Nancy
Department Name
Gastroenterology- clinical Investigation Unit
Contact Person Name
Bénédicte Caron
Contact Person Email
b.caron@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Gastroenterology an Nutrition
Contact Person Name
Cyrielle Gilletta De Saint Joseph
Contact Person Email
gilletta.c@chu-toulouse.fr
Site Name
Clinique Jules Verne
Department Name
Gastroenterology
Contact Person Name
Mathurin Flamant
Contact Person Email
mathurinflamant@hotmail.com
Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
Gastroenterology
Contact Person Name
Xavier Roblin
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Gastroenterology an Nutrition
Contact Person Name
Julien Kirchgesner
Contact Person Email
julien.kirchgesner@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Gastroenterology
Contact Person Name
Guillaume Bouguen
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'hépato-gastroentérologie et d'Oncologie digective, CMC Magellan
Contact Person Name
David Laharie
Contact Person Email
david.lahariue@chu-bordeaux.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Service de Gastro-Entérologie
Contact Person Name
Adrien NICOLAU
Contact Person Email
nicolau.a@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d'hépato-gastroentérologie et Transplantation
Contact Person Name
Romain Altwegg
Contact Person Email
r-altwegg@chu-montpellier.fr

Germany

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
26
Number Of Sites
20
Number Of Participants
68

Sites

Site Name
Klinikum Fulda gAG
Department Name
Medizinische Klinik II
Contact Person Name
Carsten Schmidt
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik fuer Innere Medizin I
Contact Person Name
Jochen Klaus
Contact Person Email
jochen.klaus@uniklinik-ulm.de
Site Name
Staedtisches Klinikum Lueneburg gGmbH
Department Name
Klinik fuer Allgemeine Innere Medizin und Gastroenterologie
Contact Person Name
Torsten Kucharzik
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik 1
Contact Person Name
Irina Blumenstein
Site Name
Eugastro GmbH
Contact Person Name
Lerner Astrid
Contact Person Email
studie@eugastro.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik fuer Innere Medizin I
Contact Person Name
Stefan Schreiber
Contact Person Email
stefan.schreiber@uksh.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Innere Medizin I
Contact Person Name
Arne Kandulski
Site Name
Studiengesellschaft BSF UG (haftungsbeschraenkt)
Contact Person Name
Lars Fechner
Contact Person Email
dr.fechner@gastro-halle.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik II
Contact Person Name
Benjamin Misselwitz
Contact Person Email
StZMed2@med.uni-muenchen.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 1
Contact Person Name
Raja Atreya
Contact Person Email
med1-studien@uk-erlangen.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin I
Contact Person Name
Leonard Kaps
Contact Person Email
leonard.kaps@uks.eu
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Innere Medizin II
Contact Person Name
Peter Hasselblatt
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Renate Schmelz
Contact Person Email
schmelz.studien@ukdd.de
Site Name
Agaplesion Frankfurter Diakonie Kliniken gGmbH
Department Name
Medizinische Klinik I
Contact Person Name
Axel Dignass
Contact Person Email
med1.mk.fdk@agaplesion.de
Site Name
Krankenhaus Waldfriede e.V.
Contact Person Name
Carsten Buening
Contact Person Email
c.buening@waldfriede.de
Site Name
DRK Kliniken Berlin
Department Name
Klinik fuer Innere Medizin
Contact Person Name
Andreas Sturm
Contact Person Email
a.sturm@drk-kliniken-berlin.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik fuer Gastroenterologie, Hepatologie und Transplantationsmedizin
Contact Person Name
Claudia Veltkamp
Contact Person Email
info@uk-essen.de
Site Name
Universitat Heidelberg
Department Name
II. Medizinische Klinik
Contact Person Name
Wolfgang Reindl
Contact Person Email
wolfgang.reindl@umm.de
Site Name
St. Marien Und St. Annastiftskrankenhaus
Department Name
Klinik für Innere Medizin
Contact Person Name
Tanja Kuehbacher
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
Contact Person Name
Christoph Jochum
Contact Person Email
christoph.jochum@charite.de

Austria

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
52
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Medical University Of Vienna
Department Name
Universitaetsklinik fuer Innere Medizin III
Contact Person Name
Walter Reinisch
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitaetsklinik Innere Medizin I
Contact Person Name
Robert Koch
Contact Person Email
robert.koch@i-med.ac.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Interne IV
Contact Person Name
Matus Gregus
Contact Person Email
matus.gregus@ordensklinikum.at
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Abteilung für Innere Medizin I
Contact Person Name
Harald Hofer
Contact Person Email
harald.hofer@klinikum-wegr.at
Site Name
Medical University Of Graz
Department Name
Universitaetsklinik fuer Innere Medizin
Contact Person Name
Andreas Blesl
Contact Person Email
andreas.blesl@medunigraz.at
Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Universitaetsklinik fuer Interne Medizin I
Contact Person Name
Sonja Heeren
Contact Person Email
s.heeren@salk.at

Portugal

Earliest CTIS Part Ii Submission Date
25-09-2024
Latest Decision Or Authorization Date
12-11-2024
Processing Time Days
48
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Unidade Local De Saude Do Alto Minho E.P.E.
Department Name
gastroenterology
Contact Person Name
Helena Ribeiro
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
gastroenterology
Contact Person Name
Tiago Goncalves
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
gastroenterology
Contact Person Name
Bruno Arroja
Contact Person Email
brunoarroja@gmail.com
Site Name
Hospital De Santa Maria E.P.E.
Department Name
gastroenterology
Contact Person Name
Samuel Fernandes
Contact Person Email
samuelrmfernandes@gmail.com
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
gastroenterology
Contact Person Name
Francisco Portela
Contact Person Email
fasportela@gmail.com
Site Name
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Department Name
gastroenterology
Contact Person Name
Cristina Chagas
Contact Person Email
cchagas@ulslo.min-saude.pt
Site Name
Unidade Local De Saude Do Alto Minho E.P.E. (additional listed site)
Department Name
gastroenterology
Contact Person Name
Helena Ribeiro

Estonia

Earliest CTIS Part Ii Submission Date
25-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
24
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Aktsiaselts Medicum Tervishoiuteenused
Department Name
Medicum
Contact Person Name
Julia Borissova
Contact Person Email
Julia.Borissova@gmail.com
Site Name
East Tallinn Central Hospital
Department Name
Gastroenterology Department
Contact Person Name
Thomas Zimmerer
Contact Person Email
thomas.zimmerer@itk.ee
Site Name
Tartu University Hospital
Department Name
Gastroenterology Department
Contact Person Name
Karin Kull
Contact Person Email
Karin.kull@kliinikum.ee

Italy

Earliest CTIS Part Ii Submission Date
15-10-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
29
Number Of Sites
12
Number Of Participants
40

Sites

Site Name
Humanitas Mirasole S.p.A.
Department Name
IBD Center - Centro Medico Chirurgico per le Malattie Infiammatorie Croniche dell’Intestino
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità di Gastroenterologia e Endoscopia Digestiva
Contact Person Name
Silvio Danese
Contact Person Email
danese.silvio@hsr.it
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
P.O. Duilio Casula - Gastroenterologia
Contact Person Name
Massimo Claudio Fantini
Contact Person Email
dir.generale@aoucagliari.it
Site Name
Casa Sollievo Della Sofferenza
Department Name
UOC di Gastroenterologia ed Endoscopia Digestiva
Contact Person Name
Fabrizio Bossa
Contact Person Email
f.bossa@operapadrepio.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
U.O.C. Gastroenterologia
Contact Person Name
Giovanni Monteleone
Contact Person Email
gi.monteleone@med.uniroma2.it
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Department Name
Centro Malattie Retto-Intestinali: Proctologia e IBD Unit
Contact Person Name
Angela Variola
Contact Person Email
angela.variola@sacrocuore.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
U.O. Gastroenterologia e Malattie Intestinali croniche
Contact Person Name
Walter Fries
Contact Person Email
fwalter@unime.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
U.O. Fisiopatologia Apparato Digerente
Contact Person Name
Francesco Luzza
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
S.C. Gastroenterologia - Endoscopia Digestiva
Contact Person Name
Marco Daperno
Contact Person Email
sperimentazioni@mauriziano.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
UOC Gastroenterologia ed Endoscopia
Contact Person Name
Flavio Caprioli
Contact Person Email
flavio.caprioli@unimi.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
CEMAD - Centro Malattie Apparato Digerente
Contact Person Name
Antonio Gasbarrini
Contact Person Email
antonio.gasbarrini@unicatt.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata (additional listed site)
Department Name
U.O.C. Gastroenterologia
Contact Person Name
Giovanni Monteleone
Contact Person Email
gi.monteleone@med.uniroma2.it

Norway

Earliest CTIS Part Ii Submission Date
20-02-2025
Latest Decision Or Authorization Date
07-03-2025
Processing Time Days
15
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Helse Moere Og Romsdal HF
Department Name
Klinisk forskningspost, Klinikk for medisin og rehabilitering
Contact Person Name
Dag Arne Dihaug Hoff
Contact Person Email
postmottak@helse-mr.no
Site Name
Oslo University Hospital HF
Contact Person Name
Marte Hoivik
Contact Person Email
moliho@ous-hf.no
Site Name
Akershus University Hospital
Department Name
Avdeling for fordøyelsessykdommer, gastrolab
Contact Person Name
Stephan Andreas Brackmann

Bulgaria

Earliest CTIS Part Ii Submission Date
18-10-2024
Latest Decision Or Authorization Date
14-11-2024
Processing Time Days
27
Number Of Sites
8
Number Of Participants
32

Sites

Site Name
Military Medical Academy
Department Name
Clinic of Gastroenterology
Contact Person Name
Daniela Stoyanova
Contact Person Email
d.stoyanova@mail.bg
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Department of Interventional Gastroenterology in Clinic of Gastroenterology
Contact Person Name
Petko Karagyozov
Contact Person Email
p_karagyozov@bitex.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Clinic of Gastroenterology
Contact Person Name
Desislav Stanchev
Contact Person Email
dessislavs@gmail.com
Site Name
Acibadem City Clinic Diagnostic And Consultation Center Ltd.
Department Name
Clinic of Gastroenterology
Contact Person Name
Asen Petrov
Contact Person Email
dr_assenp@abv.bg
Site Name
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department Name
Department of Gastroenterology
Contact Person Name
Nikolay Tsonev
Contact Person Email
dr.n.tsonev@abv.bg
Site Name
Medicinski Centar Doverie AD
Contact Person Name
Tatyana Zaharieva
Contact Person Email
dr.tatyana.zaharieva@abv.bg
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic of Gastroenterology
Contact Person Name
Plamen Penchev
Contact Person Email
penchev.dr@gmail.com
Site Name
University Hospital St Marina Varna
Department Name
Clinic of Gastroenterology
Contact Person Name
Antonia Atanassova
Contact Person Email
aniatanassova@abv.bg

Belgium

Earliest CTIS Part Ii Submission Date
29-10-2024
Latest Decision Or Authorization Date
11-11-2024
Processing Time Days
13
Number Of Sites
10
Number Of Participants
36

Sites

Site Name
CHU Saint Pierre
Department Name
Gastro-entérologie
Contact Person Name
Vinciane Muls
Contact Person Email
vinciane.muls@stpierre-bru.be
Site Name
UZ Leuven
Department Name
Maag-, darm- en leverziekten
Contact Person Name
Marc Ferrante
Contact Person Email
marc.ferrante@uzleuven.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Gastro-entérologie, Hépatologie et Oncologie digestive
Contact Person Name
Edouard Louis
Contact Person Email
edouard.louis@ulg.ac.be
Site Name
Hopital Erasme
Department Name
Gastro-enterologie
Contact Person Name
Denis Franchimont
Site Name
Imelda
Department Name
Gastro-enterologie
Contact Person Name
Peter Bossuyt
Contact Person Email
peter.bossuyt@imelda.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Gastro-entérologie
Contact Person Name
Jean-Francois Rahier
Contact Person Email
jfrahier@gmail.com
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Gastro-enterologie
Contact Person Name
Wouter Van Moerkercke
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hépato-gastro-entérologie
Contact Person Name
Olivier Dewit
Site Name
CHC MontLegia
Department Name
Gastro-entérologie
Contact Person Name
Arnaud Colard
Contact Person Email
arnaud.colard@chc.be
Site Name
Algemeen Ziekenhuis Oostende
Department Name
Gastro-enterology & hepatology
Contact Person Name
Pieter Dewint
Contact Person Email
pieter.dewint@azoostende.be

Hungary

Earliest CTIS Part Ii Submission Date
16-09-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
58
Number Of Sites
5
Number Of Participants
28

Sites

Site Name
Clinfan Kft.
Department Name
Clinfan Szolgaltato Kft.
Contact Person Name
Agnes Salamon
Contact Person Email
salamonagidr@gmail.com
Site Name
University Of Szeged
Department Name
Belgyogyaszati Klinika Nyugati telephely
Contact Person Name
Tamas Molnar
Contact Person Email
molnaribd@hotmail.com
Site Name
Semmelweis University (Ulloi Ut 78)
Department Name
Sebeszeti, Transzplantacios es Gasztroenterologiai Klinika
Contact Person Name
Pal Miheller
Contact Person Email
pmiheller@gmail.com
Site Name
Semmelweis University (Szentkiralyi Utca 46)
Department Name
Belgyogyaszati es Hematologiai Klinika
Contact Person Name
Zsolt Tulassay
Site Name
University Of Debrecen
Department Name
Gasztroenterologiai Klinika
Contact Person Name
Maria Papp
Contact Person Email
papp.maria@med.unideb.hu

Spain

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
27
Number Of Sites
10
Number Of Participants
40

Sites

Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Gastroenterology
Contact Person Name
Federico Argüelles Arias
Contact Person Email
farguelles@telefonica.net
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Gastroenterology
Contact Person Name
Guillermo Bastida Paz
Contact Person Email
guille.bastida@gmail.com
Site Name
Hospital Alvaro Cunqueiro
Department Name
Gastroenterology
Contact Person Name
Vicent Hernandez Ramirez
Site Name
Hospital Universitario 12 De Octubre
Department Name
Gastroenterology
Contact Person Name
Yago González Lama
Contact Person Email
ygonzalezlama@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Gastroenterology
Contact Person Name
Manuel Barreiro de Acosta
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Gastroenterology
Contact Person Name
Eduardo Leo Carnerero
Contact Person Email
eduardoleo70@gmail.com
Site Name
Hospital Universitario De Fuenlabrada
Department Name
Gastroenterology
Contact Person Name
Fernando Bermejo San José
Contact Person Email
fbermejos1@gmail.com
Site Name
Complexo Hospitalario Universitario De Santiago (additional listed site)
Department Name
Gastroenterology
Contact Person Name
Manuel Barreiro de Acosta
Site Name
Hospital Universitario La Paz
Department Name
Gastroenterology
Contact Person Name
María Dolores Martín Arranz
Contact Person Email
martinarranz.lapaz@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena (additional listed site)
Department Name
Gastroenterology
Contact Person Name
Federico Argüelles Arias
Contact Person Email
farguelles@telefonica.net

Poland

Earliest CTIS Part Ii Submission Date
28-10-2024
Latest Decision Or Authorization Date
18-11-2024
Processing Time Days
21
Number Of Sites
9
Number Of Participants
36

Sites

Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Contact Person Name
Patryk Korga
Contact Person Email
kermed@kermed.pl
Site Name
Malopolskie Centrum Kliniczne
Contact Person Name
Bozena Rojek-Margas
Contact Person Email
biuro@mck-krakow.pl
Site Name
Medical Network Sp. z o.o.
Contact Person Name
Jaroslaw Kierkus
Contact Person Email
j.kierkus@med-net.pl
Site Name
H-T.Centrum Medyczne Sp. z o.o. sp.k.
Contact Person Name
Tomasz Romanczyk
Contact Person Email
endoterapia@htcentrum.pl
Site Name
Bodyclinic Sp. z o.o. sp.k.
Contact Person Name
Piotr Korga
Contact Person Email
piotrgietka@gmail.com
Site Name
Endoskopia Sp. z o.o.
Contact Person Name
Dariusz Kleczkowski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Gastromed Sp. z o.o.
Contact Person Name
Adam Kopon
Contact Person Email
gastromedtrials@gmail.com
Site Name
Centrum Medyczne Kermed (additional listed site)
Contact Person Name
Patryk Korga
Contact Person Email
kermed@kermed.pl
Site Name
Malopolskie Centrum Kliniczne (additional listed site)
Contact Person Name
Bozena Rojek-Margas
Contact Person Email
biuro@mck-krakow.pl

Croatia

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
19-11-2024
Processing Time Days
36
Number Of Sites
5
Number Of Participants
24

Sites

Site Name
KBC Zagreb
Department Name
Department for gastroenterology and hepatology
Contact Person Name
Željko Krznarić
Contact Person Email
kbc-zagreb@kbc-zagreb.hr
Site Name
Poliklinika Solmed d.o.o.
Department Name
Department for gastroenterology and hepatology
Contact Person Name
Dominik Kralj
Contact Person Email
info@solmed-clinic.com
Site Name
KBC Split
Department Name
Department for gastroenterology and hepatology
Contact Person Name
Ivan Žaja
Contact Person Email
gastro_zavod@kbsplit.hr
Site Name
Specijalna Bolnica Medico
Department Name
Department for gastroenterology and hepatology
Contact Person Name
Boris Brozovic
Contact Person Email
medico@medico.hr
Site Name
Poliklinika Borzan d.o.o.
Department Name
Department for gastroenterology and hepatology
Contact Person Name
Vladimir Borzan
Contact Person Email
study@poliklinika-borzan.hr

Lithuania

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
30
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Respublikine Panevezio ligonine VšĮ
Department Name
Gastroenterology Department
Contact Person Name
Darius Kriukas
Contact Person Email
drkriukas@gmail.com
Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Santaros Clinics
Contact Person Name
Ieva Stundiene
Contact Person Email
ieva.stundiene@santa.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Gastroenterology Department
Contact Person Name
Laimas Jonaitis
Contact Person Email
laimasjonaitis@lsmuni.lt

Slovenia

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
14-11-2024
Processing Time Days
104
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Splosna Bolnisnica Celje
Department Name
Department of Gastrointestinal Diseases
Contact Person Name
Renata Sibli
Contact Person Email
renata.sibli@sb-celje.si
Site Name
University Medical Center Ljubljana
Department Name
Clinical Department of Gastroenterology
Contact Person Name
Gregor Novak
Contact Person Email
gregor.novak.gastro@kclj.si

Denmark

Earliest CTIS Part Ii Submission Date
14-02-2025
Latest Decision Or Authorization Date
13-03-2025
Processing Time Days
27
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
Odense University Hospital
Department Name
Afdeling for Medicinske Mavetarmsydomme S
Contact Person Name
Jens Kjeldsen
Contact Person Email
jens.kjeldsen@rsyd.dk
Site Name
Copenhagen University Hospital
Department Name
Digestive Disease Center
Contact Person Name
Rune Levring Wilkens
Site Name
Aarhus University Hospital
Department Name
Lever- Mave- og Tarmsygdomme Klinik
Contact Person Name
Anders Kirch Dige
Contact Person Email
andedige@rm.dk

Czechia

Earliest CTIS Part Ii Submission Date
30-10-2024
Latest Decision Or Authorization Date
13-11-2024
Processing Time Days
14
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Iscare a.s.
Contact Person Name
Milan Lukas
Contact Person Email
studie.lukas@email.cz
Site Name
SurGal Clinic s.r.o.
Contact Person Name
Jan Ulbrych
Contact Person Email
ulbrych.jan@surgalclinic.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Contact Person Name
Tomas Vanasek

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
WCG Clinical Inc.
Responsibilities
DMC
Name
Iqvia Rds Inc.
Responsibilities
Patient recruiting services and other clinical operations
Name
Medidata Solutions Inc.
Responsibilities
eCOA services and devices
Name
Advarra Inc.
Responsibilities
Central IRB services
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Laboratory services

Third parties

  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"DMC","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Expenses","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA Services and Devices","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Central IRB services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Clinical operations / patient recruiting services","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Endoscopy image, ultrasound image, intestinal Histopathology","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
ABBV-066
Active Substance
Risankizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
Lutikizumab (ABT-981)
Active Substance
Lutikizumab
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
Subcutaneous
Authorisation Status
Authorised
Investigational Product Name
ABBV-382
Active Substance
Humanised IgG1 kappa monoclonal antibody against alfa4beta7 integrin
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Route
Intravenous / Subcutaneous / Intramuscular
Authorisation Status
Authorised
Investigational Product Name
ABBV-066 / Risankizumab (infusion formulation)
Active Substance
Risankizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised
Investigational Product Name
ABBV-8736
Active Substance
ABBV-8736 (CEL-383)
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised

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