Clinical trial • Phase III • Gastroenterology

RISANKIZUMAB for Ulcerative colitis

Phase III trial of RISANKIZUMAB for Ulcerative colitis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Ulcerative colitis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
20-05-2024
First CTIS Authorization Date
21-06-2024

Trial design

Randomised, open-label, sub-study 1 comparator: placebo sc q8w vs risankizumab arms (risankizumab 180 mg sc q8w; risankizumab 360 mg sc q8w). sub-study 2 comparator: therapeutic drug monitoring (tdm) dosing strategy vs clinical assessment (ca) dosing strategy (both using risankizumab 180 mg sc open-label starting at week 8 with rescue criteria evaluated every 8 weeks).-controlled, adaptive Phase III trial in Slovenia, France, Latvia and others.

Randomised
Yes
Open Label
Yes
Comparator
Sub-study 1 comparator: Placebo SC Q8W vs Risankizumab arms (Risankizumab 180 mg SC Q8W; Risankizumab 360 mg SC Q8W). Sub-study 2 comparator: Therapeutic drug monitoring (TDM) dosing strategy vs Clinical assessment (CA) dosing strategy (both using Risankizumab 180 mg SC open-label starting at Week 8 with rescue criteria evaluated every 8 weeks).
Adaptive
True, includes dose-escalation/rescue rules evaluated every 8 weeks with Therapeutic Drug Monitoring (PK-guided) versus Clinical Assessment criteria to determine rescue/dose escalation
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
611
Trial Duration For Participant
364

Eligibility

Recruits 611 paediatric patients.

Vulnerable Population
Minors are included (assent documents present for adolescents e.g. 'Assent 16-17yo' and dedicated paediatric ICFs in some countries). Parental/guardian consent/parent information forms are provided (e.g. 'Parent Guardian Main' documents). The trial record indicates that vulnerable population flag is not selected centrally, but procedures include assent for adolescents (16-17) and parental/guardian consent where applicable; materials are provided in multiple country/language-specific versions.

Inclusion criteria

  • {"criterion_text":"- Entry and completion of Study M16-067. Completion includes the final endoscopy of Study M16 067. If the final endoscopy for Study M16-067 is missing during the COVID-19 pandemic due to local regulation prohibiting endoscopy, or due to the geo-political conflict in Ukraine and surrounding impacted regions, subjects may be allowed to enroll in Substudy 3 should they meet clinical response."}
  • {"criterion_text":"- Achieved clinical response at the last visit of Study M16-067."}

Exclusion criteria

  • {"criterion_text":"- Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study."}
  • {"criterion_text":"- Subject who has a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of CHO, or had an AE during Study M16-067 that in the Investigator's judgment makes the subject unsuitable for this study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Sub-study 1 and 2: The achievement of clinical remission per Adapted Mayo score at Week 52","definition_or_measurement_approach":"Clinical remission as assessed by the Adapted Mayo score at Week 52"}
  • {"endpoint_text":"- Sub-study 2: Selected efficacy endpoints as those listed in Sub-study 1 but comparing the Therapeutic Drug Monitoring vs Clinical Assessment arms as exploratory purpose.","definition_or_measurement_approach":"Selected efficacy endpoints (those listed in Sub-study 1) compared between TDM and Clinical Assessment arms for exploratory comparison"}
  • {"endpoint_text":"- Sub-study 3: Evaluation of long-term safety","definition_or_measurement_approach":"Long-term safety assessments (safety monitoring over the extension period)"}
  • {"endpoint_text":"- There are no efficacy endpoints for CTE.","definition_or_measurement_approach":"Not applicable (no efficacy endpoints defined for the Continuous Treatment Extension)"}

Secondary endpoints

  • {"endpoint_text":"- The achievement of endoscopic improvement at Week 52.","definition_or_measurement_approach":"Endoscopic improvement assessed at Week 52 (endoscopy)"}
  • {"endpoint_text":"- The achievement of histologic endoscopic improvement of the mucosa at Week 52.","definition_or_measurement_approach":"Histologic/endoscopic mucosal improvement assessed at Week 52"}
  • {"endpoint_text":"- The achievement of endoscopic remission at Week 52.","definition_or_measurement_approach":"Endoscopic remission assessed at Week 52"}
  • {"endpoint_text":"- The achievement of clinical remission per Adapted Mayo score at Week 52 with no corticosteroid use for 90 days.","definition_or_measurement_approach":"Clinical remission per Adapted Mayo score at Week 52 combined with corticosteroid-free status for 90 days"}
  • {"endpoint_text":"- The achievement of clinical remission per Adapted Mayo score at Week 52 in subjects with clinical remission at Week 0.","definition_or_measurement_approach":"Clinical remission (Adapted Mayo) at Week 52 in subgroup with remission at Week 0"}
  • {"endpoint_text":"- The achievement of no bowel urgency at Week 52","definition_or_measurement_approach":"Patient-reported absence of bowel urgency at Week 52"}
  • {"endpoint_text":"- The achievement of no abdominal pain at Week 52","definition_or_measurement_approach":"Patient-reported absence of abdominal pain at Week 52"}
  • {"endpoint_text":"- The achievement of histologic endoscopic mucosal remission at Week 52.","definition_or_measurement_approach":"Histologic endoscopic mucosal remission assessed at Week 52"}
  • {"endpoint_text":"- The achievement of endoscopic improvement at Week 52 in subjects with endoscopic improvement at Week 0.","definition_or_measurement_approach":"Endoscopic improvement at Week 52 in subgroup with endoscopic improvement at Week 0"}
  • {"endpoint_text":"- The achievement of clinical response per Adapted Mayo score at Week 52.","definition_or_measurement_approach":"Clinical response per Adapted Mayo score at Week 52"}
  • {"endpoint_text":"- Change from Baseline (of induction) to Week 52 in FACIT-Fatigue.","definition_or_measurement_approach":"Change in FACIT-Fatigue score from induction baseline to Week 52"}
  • {"endpoint_text":"- Change from Baseline (of induction) to Week 52 in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.","definition_or_measurement_approach":"Change in IBDQ total score from induction baseline to Week 52"}
  • {"endpoint_text":"- The achievement of no nocturnal bowel movements at Week 52.","definition_or_measurement_approach":"Patient-reported absence of nocturnal bowel movements at Week 52"}
  • {"endpoint_text":"- The achievement of no tenesmus at Week 52.","definition_or_measurement_approach":"Patient-reported absence of tenesmus at Week 52"}
  • {"endpoint_text":"- Change from Baseline (of induction) to Week 52 in number of fecal incontinence episodes per week.","definition_or_measurement_approach":"Change in weekly number of fecal incontinence episodes from induction baseline to Week 52"}
  • {"endpoint_text":"- Change from Baseline (of induction) to Week 52 in number of days over a week with sleep interrupted due to UC symptoms.","definition_or_measurement_approach":"Change in number of days per week with sleep interruption due to UC symptoms from induction baseline to Week 52"}
  • {"endpoint_text":"- Exposure adjusted Occurrence of UC-related hospitalizations through Week 52","definition_or_measurement_approach":"Exposure-adjusted incidence of UC-related hospitalizations through Week 52"}

Recruitment

Planned Sample Size
611
Recruitment Window Months
121
Consent Approach
Informed consent is obtained from participants; assent and paediatric-specific consent materials are provided where minors are included (e.g. 'Assent 16-17yo', paediatric ICFs in some countries, Parent/Guardian information and consent forms). Subject information and consent forms are available in multiple country/language-specific versions (examples in English, German, French, Italian, Spanish, Dutch, Greek, Polish, Portuguese, Czech, Latvian, Lithuanian, Romanian, Bulgarian and others as listed in the trial documents).

Geography

Total Number Of Sites
91
Total Number Of Participants
544

Slovenia

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
01-07-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
3

Sites

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

France

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
44
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
GASTRO-ENTEROLOGIE ET NUTRITION
Principal Investigator Name
Adrien NICOLAU
Principal Investigator Email
nicolau.a@chu-nice.fr
Contact Person Name
Adrien NICOLAU
Contact Person Email
nicolau.a@chu-nice.fr
Site Name
Clinique Jules Verne
Department Name
CLINIQUE JULES VERNE
Principal Investigator Name
Mathurin FLAMANT
Principal Investigator Email
mathurinflamant@hotmail.com
Contact Person Name
Mathurin FLAMANT
Contact Person Email
mathurinflamant@hotmail.com
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
CLINIQUES AMBROISE PARE
Principal Investigator Name
Xavier TRETON
Principal Investigator Email
xavier.treton@aphp.fr
Contact Person Name
Xavier TRETON
Contact Person Email
xavier.treton@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
SERVICE D’HEPATO-GASTROENTEROLOGIE ET ONCOLOGIE DIGESTIVE
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
CHRU De Nancy
Department Name
SERVICE D’HEPATOGASTROENTEROLOGIE
Principal Investigator Name
Benedicte CARON
Principal Investigator Email
b.caron@chru-nancy.fr
Contact Person Name
Benedicte CARON
Contact Person Email
b.caron@chru-nancy.fr

Latvia

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
21-06-2024
Processing Time Days
18
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Veselibas centru apvieniba AS
Department Name
Gastroenterology Department
Principal Investigator Name
Aleksejs Derovs
Principal Investigator Email
administracija@vca.lv
Contact Person Name
Aleksejs Derovs
Contact Person Email
administracija@vca.lv
Site Name
Pauls Stradins Clinical University Hospital
Department Name
Gastroenterology Department
Principal Investigator Name
Aldis Pukitis
Principal Investigator Email
elvira.nosenko@stradini.lv
Contact Person Name
Aldis Pukitis
Contact Person Email
elvira.nosenko@stradini.lv

Belgium

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
21-06-2024
Processing Time Days
18
Number Of Sites
8
Number Of Participants
62

Sites

Site Name
CHC MontLegia
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
Hopital Erasme
Principal Investigator Name
Denis Franchimont
Principal Investigator Email
denis.franchimont@hubruxelles.be
Contact Person Name
Denis Franchimont
Site Name
Imelda
Principal Investigator Name
Peter Bossuyt
Principal Investigator Email
peter.bossuyt@imelda.be
Contact Person Name
Peter Bossuyt
Contact Person Email
peter.bossuyt@imelda.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Principal Investigator Name
Jean-François Rahier
Principal Investigator Email
jfrahier@uclouvain.be
Contact Person Name
Jean-François Rahier
Contact Person Email
jfrahier@uclouvain.be
Site Name
Cliniques Universitaires Saint-Luc
Principal Investigator Name
Olivier Dewit
Principal Investigator Email
olivier.dewit@saintluc.uclouvain.be
Contact Person Name
Olivier Dewit
Site Name
Centre hospitalier universitaire de Liege
Principal Investigator Name
Edouard Louis
Principal Investigator Email
edouard.louis@chuliege.be
Contact Person Name
Edouard Louis
Contact Person Email
edouard.louis@chuliege.be
Site Name
UZ Leuven
Principal Investigator Name
Marc Ferrante
Principal Investigator Email
marc.ferrante@uzleuven.be
Contact Person Name
Marc Ferrante
Contact Person Email
marc.ferrante@uzleuven.be
Site Name
Algemeen Ziekenhuis Delta
Principal Investigator Name
Filip Baert
Principal Investigator Email
filip.baert@azdelta.be
Contact Person Name
Filip Baert
Contact Person Email
filip.baert@azdelta.be

Czechia

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
21
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Nemocnice Ceske Budejovice a.s.
Department Name
Gastroenterology
Principal Investigator Name
Martin Bortlik
Principal Investigator Email
bortlik.martin@nemcb.cz
Contact Person Name
Martin Bortlik
Contact Person Email
bortlik.martin@nemcb.cz
Site Name
Hepato-Gastroenterologie HK s.r.o.
Principal Investigator Name
Tomas Vanasek
Principal Investigator Email
tomas.vanasek@hepato-gastro.cz
Contact Person Name
Tomas Vanasek
Contact Person Email
tomas.vanasek@hepato-gastro.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Internal
Principal Investigator Name
Pavel Svoboda
Principal Investigator Email
pavel.svoboda@fno.cz
Contact Person Name
Pavel Svoboda
Contact Person Email
pavel.svoboda@fno.cz
Site Name
SurGal Clinic s.r.o.
Principal Investigator Name
Jan Ulbrych
Principal Investigator Email
ulbrych.jan@surgalclinic.cz
Contact Person Name
Jan Ulbrych
Contact Person Email
ulbrych.jan@surgalclinic.cz

Slovakia

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
21-06-2024
Processing Time Days
18
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Gastro I s.r.o.
Department Name
Gastroenterologicka ambulancia
Principal Investigator Name
Bohus Bunganic
Principal Investigator Email
gastrobunganic@gmail.com
Contact Person Name
Bohus Bunganic
Contact Person Email
gastrobunganic@gmail.com
Site Name
F D Roosevelt University General Hospital Of Banska Bystrica
Department Name
Gastroenterologicka ambulancia
Principal Investigator Name
Jozef Balaz
Principal Investigator Email
balaz@scouting.sk
Contact Person Name
Jozef Balaz
Contact Person Email
balaz@scouting.sk
Site Name
Fakultna Nemocnica S Poliklinikou Nove Zamky
Department Name
Gastroenterologicka ambulancia
Principal Investigator Name
Juraj Durina
Principal Investigator Email
jdurina@gmail.com
Contact Person Name
Juraj Durina
Contact Person Email
jdurina@gmail.com
Site Name
KM Management spol. s r.o.
Department Name
Gastroenterologicka ambulancia
Principal Investigator Name
Milos Gregus
Principal Investigator Email
ghugregus@gmail.com
Contact Person Name
Milos Gregus
Contact Person Email
ghugregus@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
21
Number Of Sites
13
Number Of Participants
76

Sites

Site Name
Gastroenterologische Gemeinschaftspraxis Minden
Principal Investigator Name
Herbert Deppe
Principal Investigator Email
info@gastroenterologie-minden.de
Contact Person Name
Herbert Deppe
Site Name
Staedtisches Klinikum Lueneburg gGmbH
Department Name
Medizinisches Zentrum Klinik für Allgemeine Innere Medizin und Gastroenterologie
Principal Investigator Name
Torsten Kucharzik
Principal Investigator Email
ced-studien@klinikum-lueneburg.de
Contact Person Name
Torsten Kucharzik
Site Name
University Hospital Cologne AöR
Principal Investigator Name
Jessica Mertens
Principal Investigator Email
duygu.cay@uk-koeln.de
Contact Person Name
Jessica Mertens
Contact Person Email
duygu.cay@uk-koeln.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik 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
Praxis Dr. Michael Mross
Principal Investigator Name
Michael Mross
Principal Investigator Email
meinhold.praxis.dr.mross@gmail.com
Contact Person Name
Michael Mross
Site Name
MVZ für Gastroenterologie am Bayerischen Platz
Principal Investigator Name
Stefan Schubert
Principal Investigator Email
drstefanschubert@web.de
Contact Person Name
Stefan Schubert
Contact Person Email
drstefanschubert@web.de
Site Name
Eugastro GmbH
Principal Investigator Name
Ingolf Schiefke
Principal Investigator Email
studien@eugastro.de
Contact Person Name
Ingolf Schiefke
Contact Person Email
studien@eugastro.de
Site Name
Universitaetsklinikum Ulm AöR
Principal Investigator Name
Jochen Klaus
Principal Investigator Email
CED-Studienambulanz.IM1@uniklinik-ulm.de
Contact Person Name
Jochen Klaus
Site Name
Universitaetsklinikum Erlangen AöR
Principal Investigator Name
Raja Atreya
Principal Investigator Email
med1-studien@uk-erlangen.de
Contact Person Name
Raja Atreya
Contact Person Email
med1-studien@uk-erlangen.de
Site Name
Gastroenterologie Opernstrasse
Principal Investigator Name
Thomas Krause
Principal Investigator Email
Krause@go-ks.de
Contact Person Name
Thomas Krause
Contact Person Email
Krause@go-ks.de
Site Name
DRK Kliniken Berlin
Principal Investigator Name
Andreas Sturm
Principal Investigator Email
a.sturm@drk-kliniken-berlin.de
Contact Person Name
Andreas Sturm
Contact Person Email
a.sturm@drk-kliniken-berlin.de
Site Name
Dr. med. Thomas Brunk Gastroenterologie Berlin
Department Name
IBD Study Center Karlshorst
Principal Investigator Name
Thomas Brunk
Contact Person Name
Thomas Brunk
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin II
Principal Investigator Name
Peter Hasselblatt
Principal Investigator Email
med.2-gi-study@uniklinik-freiburg.de
Contact Person Name
Peter Hasselblatt

Sweden

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
21
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Danderyds Sjukhus AB
Department Name
Gastromottagningen
Principal Investigator Name
Mikael Lordal
Principal Investigator Email
mikael.lordal@regionstockholm.se
Contact Person Name
Mikael Lordal

Italy

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
05-08-2024
Processing Time Days
63
Number Of Sites
14
Number Of Participants
82

Sites

Site Name
Azienda Socio Sanitaria Territoriale Rhodense
Principal Investigator Name
Simone Saibeni
Principal Investigator Email
ssaibeni@asst-rhodense.it
Contact Person Name
Simone Saibeni
Contact Person Email
ssaibeni@asst-rhodense.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Principal Investigator Name
Antonio Colecchia
Principal Investigator Email
antonio.colecchia@unimore.it
Contact Person Name
Antonio Colecchia
Contact Person Email
antonio.colecchia@unimore.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Principal Investigator Name
Michele Cicala
Principal Investigator Email
m.cicala@policlinicocampus.it
Contact Person Name
Michele Cicala
Contact Person Email
m.cicala@policlinicocampus.it
Site Name
IRCCS Ospedale Policlinico San Martino
Principal Investigator Name
Edoardo Giovanni Giannini
Principal Investigator Email
egiannini@unige.it
Contact Person Name
Edoardo Giovanni Giannini
Contact Person Email
egiannini@unige.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Principal Investigator Name
Marcello Vangeli
Principal Investigator Email
marcello.vangeli@ospedaleniguarda.it
Contact Person Name
Marcello Vangeli
Site Name
Azienda Ospedaliera Per L'Emergenza Cannizzaro
Principal Investigator Name
Maria Emanuela Distefano
Principal Investigator Email
eliadis1966@gmail.com
Contact Person Name
Maria Emanuela Distefano
Contact Person Email
eliadis1966@gmail.com
Site Name
ASST Fatebenefratelli Sacco
Principal Investigator Name
Alessandro Massari
Principal Investigator Email
massari.alessandro@asst-fbf-sacco.it
Contact Person Name
Alessandro Massari
Site Name
San Camillo Forlanini Hospital
Principal Investigator Name
Rocco Cosintino
Principal Investigator Email
rcosintino@scamilloforlanini.rm.it
Contact Person Name
Rocco Cosintino
Site Name
IRCCS Ospedale Sacro Cuore Don Calabria
Principal Investigator Name
Angela Variola
Principal Investigator Email
angela.variola@sacrocuore.it
Contact Person Name
Angela Variola
Contact Person Email
angela.variola@sacrocuore.it
Site Name
Azienda Ospedaliera Universitaria Mater Domini
Principal Investigator Name
Francesco Luzza
Principal Investigator Email
luzza@unicz.it
Contact Person Name
Francesco Luzza
Contact Person Email
luzza@unicz.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Principal Investigator Name
Fernando Rizzello
Principal Investigator Email
fernando.rizzello@unibo.it
Contact Person Name
Fernando Rizzello
Contact Person Email
fernando.rizzello@unibo.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Principal Investigator Name
Giovanni Monteleone
Principal Investigator Email
gi.monteleone@med.uniroma2.it
Contact Person Name
Giovanni Monteleone
Contact Person Email
gi.monteleone@med.uniroma2.it
Site Name
Humanitas Research Hospital
Principal Investigator Name
Alessandro Armuzzi
Principal Investigator Email
alessandro.armuzzi@hunimed.eu
Contact Person Name
Alessandro Armuzzi
Contact Person Email
alessandro.armuzzi@hunimed.eu

Croatia

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
25-06-2024
Processing Time Days
22
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
KBC Zagreb
Department Name
Department for gastroenterology and hepatology
Principal Investigator Name
Zeljko Krznarić
Principal Investigator Email
kbc-zagreb@kbc-zagreb.hr
Contact Person Name
Zeljko Krznarić
Contact Person Email
kbc-zagreb@kbc-zagreb.hr
Site Name
KBC Split
Department Name
Department for gastroenterology and hepatology
Principal Investigator Name
Zeljko Puljiz
Principal Investigator Email
office@kbsplit.hr
Contact Person Name
Zeljko Puljiz
Contact Person Email
office@kbsplit.hr
Site Name
Poliklinika Borzan d.o.o.
Department Name
Department for gastroenterology
Principal Investigator Name
Vladimir Borzan
Principal Investigator Email
study@poliklinika-borzan.hr
Contact Person Name
Vladimir Borzan
Contact Person Email
study@poliklinika-borzan.hr

Spain

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
21-06-2024
Processing Time Days
18
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Hospital Unviersitario Miguel Servet
Department Name
Digestive
Principal Investigator Name
Santiago Garcia Lopez
Principal Investigator Email
informacion.sector2@salud.aragon.es
Contact Person Name
Santiago Garcia Lopez
Site Name
Hospital Universitario La Paz
Department Name
Gastroenterology
Principal Investigator Name
Maria Dolores Martin Arranz
Principal Investigator Email
mariadolores.martin@uam.es
Contact Person Name
Maria Dolores Martin Arranz
Contact Person Email
mariadolores.martin@uam.es
Site Name
Hospital Universitario De Cabuenes
Department Name
Gastroenterology
Principal Investigator Name
Pilar Varela Trastoy
Principal Investigator Email
trastoy@hotmail.com
Contact Person Name
Pilar Varela Trastoy
Contact Person Email
trastoy@hotmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Clinical Pharmacology
Principal Investigator Name
Maria Isabel Vera Mendoza
Principal Investigator Email
maria.vera@uam.es
Contact Person Name
Maria Isabel Vera Mendoza
Contact Person Email
maria.vera@uam.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Digestive
Principal Investigator Name
Federico Argüelles Arias
Principal Investigator Email
farguelles1@us.es
Contact Person Name
Federico Argüelles Arias
Contact Person Email
farguelles1@us.es
Site Name
Area Sanitaria De Ferrol
Department Name
Digestive
Principal Investigator Name
Ana Echarri Piudo
Principal Investigator Email
soporte.investigador.acis@sergas.es
Contact Person Name
Ana Echarri Piudo

Romania

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
23
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Centrul de Gastroenterologie si Hepatologie, Sectia Clinica Gastroenterologie II
Principal Investigator Name
Mihai-Mircea Diculescu
Principal Investigator Email
gastroenterologie2@icfundeni.ro
Contact Person Name
Mihai-Mircea Diculescu
Site Name
Cabinet Particular Policlinic Algomed S.R.L.
Department Name
Gastroenterologie
Principal Investigator Name
Adrian- Eugen Goldis
Principal Investigator Email
goldisadi@yahoo.com
Contact Person Name
Adrian- Eugen Goldis
Contact Person Email
goldisadi@yahoo.com
Site Name
Gastro Med S.R.L.
Department Name
Gastroenterologie
Principal Investigator Name
Andrada Seicean
Principal Investigator Email
contact@clinica-gastromed.ro
Contact Person Name
Andrada Seicean
Contact Person Email
contact@clinica-gastromed.ro

Lithuania

Earliest CTIS Part Ii Submission Date
19-07-2024
Latest Decision Or Authorization Date
07-08-2024
Processing Time Days
19
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name
Gastroenterology
Principal Investigator Name
Ieva Stundiene
Principal Investigator Email
ieva.stundiene@santa.lt
Contact Person Name
Ieva Stundiene
Contact Person Email
ieva.stundiene@santa.lt
Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
Gastroenterology
Principal Investigator Name
Laimas Jonaitis
Principal Investigator Email
laimasjonaitis@yahoo.com
Contact Person Name
Laimas Jonaitis
Contact Person Email
laimasjonaitis@yahoo.com

Netherlands

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
24-06-2024
Processing Time Days
21
Number Of Sites
1
Number Of Participants
15

Sites

Site Name
Amsterdam UMC Stichting
Principal Investigator Name
Geert D'Haens
Principal Investigator Email
ctis@amsterdamumc.nl
Contact Person Name
Geert D'Haens
Contact Person Email
ctis@amsterdamumc.nl

Poland

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
17-07-2024
Processing Time Days
44
Number Of Sites
9
Number Of Participants
110

Sites

Site Name
Vitamed Galaj I Cichomski Sp. j.
Principal Investigator Name
Piotr Sikorski
Principal Investigator Email
p.sikorski@vitamed.info
Contact Person Name
Piotr Sikorski
Contact Person Email
p.sikorski@vitamed.info
Site Name
Endoskopia Sp. z o.o.
Principal Investigator Name
Dariusz Kleczkowski
Principal Investigator Email
badanie.kliniczne@wp.pl
Contact Person Name
Dariusz Kleczkowski
Contact Person Email
badanie.kliniczne@wp.pl
Site Name
Eb Group Sp. z o.o.
Principal Investigator Name
Michał Talarek
Principal Investigator Email
michal.talarek@czmdm.pl
Contact Person Name
Michał Talarek
Contact Person Email
michal.talarek@czmdm.pl
Site Name
Gastromed Sp. z o.o.
Principal Investigator Name
Adam Kopoń
Principal Investigator Email
adamkopon@interia.pl
Contact Person Name
Adam Kopoń
Contact Person Email
adamkopon@interia.pl
Site Name
H-T.Centrum Medyczne Sp. z o.o.
Principal Investigator Name
Tomasz Romańczyk
Principal Investigator Email
romanczyk@htcentrum.pl
Contact Person Name
Tomasz Romańczyk
Contact Person Email
romanczyk@htcentrum.pl
Site Name
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Department Name
Klinika Gastroenterologii Onkologicznej
Principal Investigator Name
Jarosław Reguła
Principal Investigator Email
jaroslaw.regula@nio.gov.pl
Contact Person Name
Jarosław Reguła
Contact Person Email
jaroslaw.regula@nio.gov.pl
Site Name
Vivamed Sp. z o.o.
Principal Investigator Name
Robert Petryka
Principal Investigator Email
robert@petrykamed.com
Contact Person Name
Robert Petryka
Contact Person Email
robert@petrykamed.com
Site Name
Economicus Sp. z o.o.
Principal Investigator Name
Jerzy Eszyk
Principal Investigator Email
jweszyk@wp.pl
Contact Person Name
Jerzy Eszyk
Contact Person Email
jweszyk@wp.pl
Site Name
Medical Network Sp. z o.o.
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

Greece

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
22-07-2024
Processing Time Days
49
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
Hippokration Hospital
Department Name
2nd Internal Medicine Department
Principal Investigator Name
Spilios Manolakopoulos
Principal Investigator Email
smanolak@med.uoa.gr
Contact Person Name
Spilios Manolakopoulos
Contact Person Email
smanolak@med.uoa.gr
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
3rd University Internal Medicine Department
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
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
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I
Department Name
Gastroenterology Department
Principal Investigator Name
Maria Tzouvala
Principal Investigator Email
tzouvalam@gmail.com
Contact Person Name
Maria Tzouvala
Contact Person Email
tzouvalam@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
01-07-2024
Processing Time Days
28
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Clinic of Gastroenterology
Principal Investigator Name
Plamen Penchev
Principal Investigator Email
penchev.dr@gmail.com
Contact Person Name
Plamen Penchev
Contact Person Email
penchev.dr@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Department of Gastroenterology
Principal Investigator Name
Desislav Stanchev
Principal Investigator Email
dessislavs@gmail.com
Contact Person Name
Desislav Stanchev
Contact Person Email
dessislavs@gmail.com

Portugal

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
23
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Gastrology
Principal Investigator Name
Tiago Gonçalves
Contact Person Name
Tiago Gonçalves
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Gastrology
Principal Investigator Name
Susana Lopes
Principal Investigator Email
su.isa.lopes@gmail.com
Contact Person Name
Susana Lopes
Contact Person Email
su.isa.lopes@gmail.com
Site Name
Unidade Local de Saude do Algarve E.P.E.
Department Name
Gastrology
Principal Investigator Name
Helena Tavares
Principal Investigator Email
helenatsousa@gmail.com
Contact Person Name
Helena Tavares
Contact Person Email
helenatsousa@gmail.com
Site Name
Centro Hospitalar Tondela-Viseu (CHTV E.P.E.)
Department Name
Gastrology
Principal Investigator Name
Paula Ministro
Principal Investigator Email
paula.ministro.4342@hstviseu.min-saude.pt
Contact Person Name
Paula Ministro
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Gastrology
Principal Investigator Name
Francisco Portela
Principal Investigator Email
fasportela@gmail.com
Contact Person Name
Francisco Portela
Contact Person Email
fasportela@gmail.com
Site Name
Unidade Local De Saude Do Alto Ave E.P.E. (duplicate listing?)
Department Name
Gastrology
Principal Investigator Name
Tiago Gonçalves
Contact Person Name
Tiago Gonçalves

Austria

Earliest CTIS Part Ii Submission Date
03-06-2024
Latest Decision Or Authorization Date
26-06-2024
Processing Time Days
23
Number Of Sites
2
Number Of Participants
29

Sites

Site Name
Medical University Of Vienna
Department Name
Department of Medicine III - Division of Gastroenterology and Hepatology
Principal Investigator Name
Walter Reinisch
Principal Investigator Email
walter.reinisch@meduniwien.ac.at
Contact Person Name
Walter Reinisch
Site Name
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Department Name
Department of 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

Sponsor

Primary sponsor

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

Contract research organisations

Name
Endpoint Clinical Inc.
Responsibilities
IVRS - Treatment Randomization
Name
Signant Health Global LLC
Responsibilities
eCOA/eSource or related data capture support (sponsor duty code 7)
Name
Medidata Solutions Inc.
Responsibilities
Electronic data capture / trial technology (sponsor duty code 7)
Name
WCG Clinical Inc.
Responsibilities
External Adjudication Committee - cardiac/cerebrovascular and anaphylaxis adjudication
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Laboratory services (sponsor duty code 4)

Third parties

  • {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"IVRS - Treatment Randomization","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"External Adjudication Committee (Cardiac/Cerebro-vascular – CAC, Anaphylaxis – AAC)","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Risankizumab
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
180 mg
Dose Levels
180 mg; 360 mg
Frequency
Q8W
Maximum Dose
360 mg
Dose Escalation Increase
180 mg -> 360 mg
Investigational Product Name
ABBV-066
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Authorisation Status
Authorised
Starting Dose
180 mg
Dose Levels
180 mg; 360 mg
Frequency
Q8W
Maximum Dose
360 mg
Dose Escalation Increase
180 mg -> 360 mg
Investigational Product Name
Risankizumab (infusion formulation)
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Starting Dose
Not specified in Part I (used for induction in other study M16-067)
Frequency
As per induction regimen (not specified in this record)
Maximum Dose
1200 mg
Investigational Product Name
ABBV-066 / Risankizumab (infusion)
Active Substance
RISANKIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised
Maximum Dose
1200 mg
Investigational Product Name
Risankizumab placebo solution for infusion
Modality
Other
Investigational Product Name
Risankizumab placebo solution for injection in pre-filled syringe
Modality
Other

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