Clinical trial • Phase III • Gastroenterology
GUSELKUMAB for Crohn's disease
Phase III trial of GUSELKUMAB for Crohn's disease. open-label. 186 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Crohn's disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-07-2024
- First CTIS Authorization Date
- 29-10-2024
Trial design
open-label Phase III trial across 61 sites in Czechia, Spain, Germany and others.
- Open Label
- Yes
- Target Sample Size
- 186
- Trial Duration For Participant
- 336
Eligibility
Recruits 186 adults.
Inclusion criteria
- {"criterion_text":"- Has luminal Crohn’s disease (CD) of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy\n- Has clinically active CD, defined as a baseline CD activity index (CDAI) score greater than or equal to (>=)220 but <=450 and either: a. Mean daily stool frequency (SF) count >=4, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score >=2, based on the unweighted CDAI component of abdominal pain (AP)\n- Active transmural activity in at least one segment (segmental magnetic resonance index of activity [MaRIA] >= 11)\n- a. Has demonstrated inadequate response/intolerance to conventional therapy; b. Has previously demonstrated lack of initial response (that is, primary non‐responders), responded initially but then lost response with continued therapy (that is, secondary non-responders), or was intolerant to a maximum of 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (that is, janus kinase [JAK] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents)"}
Exclusion criteria
- {"criterion_text":"- Has complications of Crohn’s disease, such as symptomatic strictures or stenoses (unless less than [<]3 centimeter (cm) dilatation and not symptomatic or displaying associated fistula/fistulae and/or or abscess), fibrotic stenosis, internal fistulas, short gut syndrome, or any other manifestation, that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab\n- Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline, or 8 weeks before baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participants with active perianal fistulas may be included if there are no associated stenoses, no anticipated surgery and no abscesses currently identified\n- Has had any kind of bowel resection within 6 months, or any other intra-abdominal or other major surgery within 12 weeks before baseline\n- Has a draining (that is, functioning) stoma or ostomy\n- Has a stool culture or other examination positive for an enteric pathogen, including Clostridioides difficile (formerly known as Clostridium difficile) toxin, in the previous 4 months, unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants achieving a Magnetic Resonance Index of Activity (MaRIA) <11 in all intestinal segments, at Week 48.","definition_or_measurement_approach":"MaRIA score <11 in all intestinal segments at Week 48 as measured by MRI using the Magnetic Resonance Index of Activity (MaRIA)."}
Recruitment
- Planned Sample Size
- 186
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent is obtained from adult participants. Country-specific participant information and informed consent forms (ICFs) and related documents are provided (titles indicate available ICFs in English, Czech, Spanish, French, German, Polish, Slovak, Italian, Dutch). Caregiver ICFs and pregnancy-specific information/medical release forms are available where indicated. No assent process for minors is described.
Geography
- Total Number Of Sites
- 61
- Total Number Of Participants
- 186
Czechia
- Earliest CTIS Part Ii Submission Date
- 26-07-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 591
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Hepato-Gastroenterologie HK s.r.o.
- Department Name
- CZ10003: Hepto - gastroenterologie
- Principal Investigator Name
- Miroslava Volfova
- Principal Investigator Email
- miroslava.volfova@hepato-gastro.com
- Contact Person Name
- Miroslava Volfova
- Contact Person Email
- miroslava.volfova@hepato-gastro.com
- Site Name
- Iscare a.s.
- Department Name
- CZ10002: IBD a gastroenterologie
- Principal Investigator Name
- Milan Lukas
- Principal Investigator Email
- milan.lukas@email.cz
- Contact Person Name
- Milan Lukas
- Contact Person Email
- milan.lukas@email.cz
- Site Name
- Nemocnice Ceske Budejovice a.s.
- Department Name
- CZ10001: Gastroenterologicke oddeleni
- Principal Investigator Name
- Martin Bortlik
- Principal Investigator Email
- mbortlik@seznam.cz
- Contact Person Name
- Martin Bortlik
- Contact Person Email
- mbortlik@seznam.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 526
- Number Of Sites
- 8
- Number Of Participants
- 11
Sites
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- ES10005: Aparato Digestivo
- Principal Investigator Name
- Eva Iglesias Flores
- Principal Investigator Email
- evaiglesiasensayos1@gmail.com
- Contact Person Name
- Eva Iglesias Flores
- Contact Person Email
- evaiglesiasensayos1@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- ES10002: Aparato Digestivo
- Principal Investigator Name
- Javier Pérez Gisbert
- Principal Investigator Email
- javier.p.gisbert@gmail.com
- Contact Person Name
- Javier Pérez Gisbert
- Contact Person Email
- javier.p.gisbert@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- ES10001: Aparato Digestivo
- Principal Investigator Name
- Natalia Garcia Morales
- Principal Investigator Email
- natalia.garcia.morales@sergas.es
- Contact Person Name
- Natalia Garcia Morales
- Contact Person Email
- natalia.garcia.morales@sergas.es
- Site Name
- Area Sanitaria De Ferrol
- Department Name
- ES10004: Aparato Digestivo
- Principal Investigator Name
- Ana Echarri Piudo
- Principal Investigator Email
- ana.echarri.piudo@sergas.es
- Contact Person Name
- Ana Echarri Piudo
- Contact Person Email
- ana.echarri.piudo@sergas.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- ES10009: Gastroenterología
- Principal Investigator Name
- Maria Isabel Vera Mendoza
- Principal Investigator Email
- isabel.veramendoza@gmail.com
- Contact Person Name
- Maria Isabel Vera Mendoza
- Contact Person Email
- isabel.veramendoza@gmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- ES10008: Aparato Digestivo
- Principal Investigator Name
- Ana Gutierrez Casbas
- Principal Investigator Email
- gutierrez_anacas@gva.es
- Contact Person Name
- Ana Gutierrez Casbas
- Contact Person Email
- gutierrez_anacas@gva.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- ES10003: Aparato Digestivo
- Principal Investigator Name
- María Martín Arranz
- Principal Investigator Email
- mmartinarranz@salud.madrid.org
- Contact Person Name
- María Martín Arranz
- Contact Person Email
- mmartinarranz@salud.madrid.org
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- ES10007: Gastroenterologia
- Principal Investigator Name
- Carles Suria Bolufer
- Principal Investigator Email
- carles_71191@hotmail.com
- Contact Person Name
- Carles Suria Bolufer
- Contact Person Email
- carles_71191@hotmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 503
- Number Of Sites
- 13
- Number Of Participants
- 17
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- DE10015: Klinik für Gastroenterologie, gastrointestinale Onkologie und Endokrinologie
- Principal Investigator Name
- Alexander Koenig
- Principal Investigator Email
- alexander.koenig@med.uni-goettingen.de
- Contact Person Name
- Alexander Koenig
- Contact Person Email
- alexander.koenig@med.uni-goettingen.de
- Site Name
- Staedtisches Klinikum Lueneburg gGmbH
- Department Name
- DE10012: Klinik fur Allgemeine Innere Medizin und Gastroenterologie
- Principal Investigator Name
- Christian Maaser
- Principal Investigator Email
- christian.maaser@klinikum-lueneburg.de
- Contact Person Name
- Christian Maaser
- Contact Person Email
- christian.maaser@klinikum-lueneburg.de
- Site Name
- MVZ Dachau
- Department Name
- DE10013: Endoscopy
- Principal Investigator Name
- Wilfred Landry
- Principal Investigator Email
- landry@dachau-med.de
- Contact Person Name
- Wilfred Landry
- Contact Person Email
- landry@dachau-med.de
- Site Name
- Mvz Portal 10
- Department Name
- DE10006: Gastroenterology
- Principal Investigator Name
- Andreas Lügering
- Principal Investigator Email
- Luegering@mvz-portal10.de
- Contact Person Name
- Andreas Lügering
- Contact Person Email
- Luegering@mvz-portal10.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- DE10011: Interdisziplinäres Stoffwechselzentrum
- Principal Investigator Name
- Christoph Jochum
- Principal Investigator Email
- christoph.jochum@charite.de
- Contact Person Name
- Christoph Jochum
- Contact Person Email
- christoph.jochum@charite.de
- Site Name
- Studiengesellschaft BSF UG
- Department Name
- DE10005: Unternehmergesellschaft (haftungsbeschränkt)
- 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
- Universitätsklinikum Augsburg
- Department Name
- DE10008: Klinikum Augsburg - III. Med. Klinik
- Principal Investigator Name
- Elisabeth Schnoy
- Principal Investigator Email
- elisabeth.schnoy@uk-augsburg.de
- Contact Person Name
- Elisabeth Schnoy
- Contact Person Email
- elisabeth.schnoy@uk-augsburg.de
- Site Name
- Gastro-Studien Studienzentrum
- Department Name
- DE10001: Gastro-Studien Studienzentrum
- Principal Investigator Name
- Stefan Schubert
- Principal Investigator Email
- drstefanschubert@web.de
- Contact Person Name
- Stefan Schubert
- Contact Person Email
- drstefanschubert@web.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- DE10007: Gastroenterologie, Endokrinologie
- Principal Investigator Name
- Jochen Klaus
- Principal Investigator Email
- jochen.klaus@uniklinik-ulm.de
- Contact Person Name
- Jochen Klaus
- Contact Person Email
- jochen.klaus@uniklinik-ulm.de
- Site Name
- Siloah St Trudpert Klinikum
- Department Name
- D10016: Klinik für Innere Medizin 1
- Principal Investigator Name
- Oliver Bachmann
- Principal Investigator Email
- o.bachmann@siloah.de
- Contact Person Name
- Oliver Bachmann
- Contact Person Email
- o.bachmann@siloah.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein
- Department Name
- DE10004: Innere Medizin I
- Principal Investigator Name
- Stefan Schreiber
- Principal Investigator Email
- s.schreiber@mucosa.de
- Contact Person Name
- Stefan Schreiber
- Contact Person Email
- s.schreiber@mucosa.de
- Site Name
- Goethe University Frankfurt
- Department Name
- DE10002: Medical Clinic 1
- Principal Investigator Name
- Irina Blumenstein
- Principal Investigator Email
- Irina.Blumenstein@kgu.de
- Contact Person Name
- Irina Blumenstein
- Contact Person Email
- Irina.Blumenstein@kgu.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- DE10009: Klinik für Gastroenterologie, Hepatologie und Endokrinologie
- Principal Investigator Name
- Ursula Seidler
- Principal Investigator Email
- seidler.ursula@mh-hannover.de
- Contact Person Name
- Ursula Seidler
- Contact Person Email
- seidler.ursula@mh-hannover.de
Poland
- Earliest CTIS Part Ii Submission Date
- 02-12-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 468
- Number Of Sites
- 9
- Number Of Participants
- 45
Sites
- Site Name
- Melita Medical Sp. z o.o.
- Department Name
- PL10007: Gastroneterology
- Principal Investigator Name
- Jaroslaw Leszczyszyn
- Principal Investigator Email
- j.leszczyszyn@melitamedical.pl
- Contact Person Name
- Jaroslaw Leszczyszyn
- Contact Person Email
- j.leszczyszyn@melitamedical.pl
- Site Name
- Sonomed Sp. z o.o.
- Department Name
- PL10001: Gastroneterology
- Principal Investigator Name
- Anna Wiechowska - Kozlowska
- Principal Investigator Email
- anna.kozlowska@sonomedszczecin.pl
- Contact Person Name
- Anna Wiechowska - Kozlowska
- Contact Person Email
- anna.kozlowska@sonomedszczecin.pl
- Site Name
- Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
- Department Name
- PL10006: gastroenterology
- Principal Investigator Name
- Patryk Korga
- Principal Investigator Email
- patryk.korga@kermed.pl
- Contact Person Name
- Patryk Korga
- Contact Person Email
- patryk.korga@kermed.pl
- Site Name
- Gastromed Sp. z o.o.
- Department Name
- PL10010: Gastroneterology
- Principal Investigator Name
- Marcin Zmudzinski
- Principal Investigator Email
- m.zmudek2@gmail.com
- Contact Person Name
- Marcin Zmudzinski
- Contact Person Email
- m.zmudek2@gmail.com
- Site Name
- EMC Instytut Medyczny S.A.
- Department Name
- PL10003: EuroMediCare Szpital Specjalistyczny z Przychodnia
- Principal Investigator Name
- Patryk Smolinski
- Principal Investigator Email
- psmolinski@poczta.onet.pl
- Contact Person Name
- Patryk Smolinski
- Contact Person Email
- psmolinski@poczta.onet.pl
- Site Name
- Centrum Medyczne Oporow
- Department Name
- PL10002: Gastroneterology
- Principal Investigator Name
- Radoslaw Kempinski
- Principal Investigator Email
- kempinski.wroclaw@gmail.com
- Contact Person Name
- Radoslaw Kempinski
- Contact Person Email
- kempinski.wroclaw@gmail.com
- Site Name
- Pro Life Medica Sp. z o.o.
- Department Name
- PL10004: gastroenterology
- Principal Investigator Name
- Katarzyna Wojcik
- Principal Investigator Email
- k.wojcik@etg-network.com
- Contact Person Name
- Katarzyna Wojcik
- Contact Person Email
- k.wojcik@etg-network.com
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- PL0008: gastroenterology
- Principal Investigator Name
- Jaroslaw Kierkus
- Principal Investigator Email
- j.kierkus@med-net.pl
- Contact Person Name
- Jaroslaw Kierkus
- Contact Person Email
- j.kierkus@med-net.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o.
- Department Name
- PL10005: gastroenterology
- Principal Investigator Name
- Rafal Filip
- Principal Investigator Email
- r.s.filip@wp.pl
- Contact Person Name
- Rafal Filip
- Contact Person Email
- r.s.filip@wp.pl
France
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 10-03-2026
- Processing Time Days
- 295
- Number Of Sites
- 6
- Number Of Participants
- 40
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- FR10005:Gastro-entérologie
- Principal Investigator Name
- Anne-Laure Pelletier
- Principal Investigator Email
- anne-laure.pelletier@aphp.fr
- Contact Person Name
- Anne-Laure Pelletier
- Contact Person Email
- anne-laure.pelletier@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- FR10008:Gastroentérologie Et Hepatolog
- 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 Lille
- Department Name
- FR10010:Gastro entérologie
- Principal Investigator Name
- Pauline WILS
- Principal Investigator Email
- pauline.wils@chru-lille.fr
- Contact Person Name
- Pauline WILS
- Contact Person Email
- pauline.wils@chru-lille.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- FR10002 Hépato-Gastroentérologie
- Principal Investigator Name
- Melanie SERRERO
- Principal Investigator Email
- melanie.serrero@ap-hm.fr
- Contact Person Name
- Melanie SERRERO
- Contact Person Email
- melanie.serrero@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- FR10004 Hépato-Gastroentérologie
- Principal Investigator Name
- Arnaud Bourreille
- Principal Investigator Email
- arnaud.bourreille@chu-nantes.fr
- Contact Person Name
- Arnaud Bourreille
- Contact Person Email
- arnaud.bourreille@chu-nantes.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- FR10003 Service d'Hépatologie et de Ga
- Principal Investigator Name
- Anthony Buisson
- Principal Investigator Email
- a_buisson@chu-clermontferrand.fr
- Contact Person Name
- Anthony Buisson
- Contact Person Email
- a_buisson@chu-clermontferrand.fr
Slovakia
- Earliest CTIS Part Ii Submission Date
- 15-10-2024
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 510
- Number Of Sites
- 5
- Number Of Participants
- 8
Sites
- Site Name
- F D Roosevelt University General Hospital Of Banska Bystrica
- Department Name
- SK10002: II. Interna klinika
- Principal Investigator Name
- Jozef Balaz
- Principal Investigator Email
- balaz@scouting.sk
- Contact Person Name
- Jozef Balaz
- Contact Person Email
- balaz@scouting.sk
- Site Name
- Cliniq s.r.o.
- Department Name
- SK10005: Gastroenterologicka ambulancia
- Principal Investigator Name
- Tibor Hlavaty
- Principal Investigator Email
- tibor.hlavaty2@gmail.com
- Contact Person Name
- Tibor Hlavaty
- Contact Person Email
- tibor.hlavaty2@gmail.com
- Site Name
- Gastro I. s.r.o.
- Department Name
- SK10001, Gastroenterologicka ambulacia
- Principal Investigator Name
- Bohus Bunganic
- Principal Investigator Email
- gastrobunganic@gmail.com
- Contact Person Name
- Bohus Bunganic
- Contact Person Email
- gastrobunganic@gmail.com
- Site Name
- KM Management spol. s r.o.
- Department Name
- SK10004, Gastroenterologicka ambulancia
- Principal Investigator Name
- Milos Gregus
- Principal Investigator Email
- kmmanagement@gmail.com
- Contact Person Name
- Milos Gregus
- Contact Person Email
- kmmanagement@gmail.com
- Site Name
- Endomed s.r.o.
- Department Name
- SK10003, Gastroenterologicka ambulancia
- Principal Investigator Name
- Miroslav Fedurco
- Principal Investigator Email
- fedurco@endomed.sk
- Contact Person Name
- Miroslav Fedurco
- Contact Person Email
- fedurco@endomed.sk
Italy
- Earliest CTIS Part Ii Submission Date
- 26-07-2024
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 594
- Number Of Sites
- 13
- Number Of Participants
- 14
Sites
- Site Name
- Casa Sollievo Della Sofferenza
- Department Name
- IT10005:Gastroenterologia e 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
- Azienda Unita' Sanitaria Locale Toscana Nord Ovest
- Department Name
- IT10014:NA
- Principal Investigator Name
- Lorenzo Bertani
- Principal Investigator Email
- lorenzobertani@gmail.com
- Contact Person Name
- Lorenzo Bertani
- Contact Person Email
- lorenzobertani@gmail.com
- Site Name
- Humanitas Research Hospital
- Department Name
- IT10001:IBD Center
- Principal Investigator Name
- Alessandro Armuzzi
- Principal Investigator Email
- clinicaltrialsibd@humanitas.it
- Contact Person Name
- Alessandro Armuzzi
- Contact Person Email
- clinicaltrialsibd@humanitas.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- IT10002:UOC Oncologia Medica
- Principal Investigator Name
- Alessandra Zilli
- Principal Investigator Email
- zilli.alessandra@hsr.it
- Contact Person Name
- Alessandra Zilli
- Contact Person Email
- zilli.alessandra@hsr.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- IT10010:U.O.C. Gastroenterologia
- Principal Investigator Name
- Emma Calabrese
- Principal Investigator Email
- emmac@libero.it
- Contact Person Name
- Emma Calabrese
- Contact Person Email
- emmac@libero.it
- Site Name
- Catholic University Of Sacred Heart
- Department Name
- IT10004:Medicina Interna e Gastroenterologia - Policlinico A.Gemelli
- 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 IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- IT10007:U.O. Medicina Interna 3
- Principal Investigator Name
- Flavio Caprioli
- Principal Investigator Email
- flavio.caprioli@policlinico.mi.it
- Contact Person Name
- Flavio Caprioli
- Contact Person Email
- flavio.caprioli@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- IT10011
- 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 Sanitaria Universitaria Friuli Centrale
- Department Name
- IT10015:Gastroenterologia
- Principal Investigator Name
- Marco Marino
- Principal Investigator Email
- marco.marino@asufc.sanita.fvg.it
- Contact Person Name
- Marco Marino
- Contact Person Email
- marco.marino@asufc.sanita.fvg.it
- Site Name
- Universita' Campus Bio-medico Di Roma
- Department Name
- IT10003:UOC di Gastroenterologia
- 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
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- IT10008
- 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 Socio Sanitaria Territoriale Rhodense
- Department Name
- IT10009:UOC di Gastroenterologia
- Principal Investigator Name
- Simone Saibeni
- Principal Investigator Email
- saibo@tiscali.it
- Contact Person Name
- Simone Saibeni
- Contact Person Email
- saibo@tiscali.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- IT10006:cardiologia
- Principal Investigator Name
- Stefania Carmagnola
- Principal Investigator Email
- stefania.carmagnola@asst-fbf-sacco.it
- Contact Person Name
- Stefania Carmagnola
- Contact Person Email
- stefania.carmagnola@asst-fbf-sacco.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 21-07-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 253
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Vitaz
- Department Name
- BE10002:Gastro-enterologie
- Principal Investigator Name
- Tom Holvoet
- Principal Investigator Email
- tom.holvoet@vitaz.be
- Contact Person Name
- Tom Holvoet
- Contact Person Email
- tom.holvoet@vitaz.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- BE10001: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
- Az Maria Middelares Gent
- Department Name
- BE10003:Gastro-enterologie
- Principal Investigator Name
- Didier Baert
- Principal Investigator Email
- didier.baert@mijnziekenhuis.be
- Contact Person Name
- Didier Baert
- Contact Person Email
- didier.baert@mijnziekenhuis.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- BE10008:Gastro-entérologie
- Principal Investigator Name
- Edouard Louis
- Principal Investigator Email
- edouard.louis@uliege.be
- Contact Person Name
- Edouard Louis
- Contact Person Email
- edouard.louis@uliege.be
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- IWRS (Interactive Web Response System)
- Name
- Parexel International (IRL) Limited
- Responsibilities
- codes: 1,12,2,5,6,8
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Patient Reported Outcomes and eDiary
Third parties
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"IWRS (Interactive Web Response System)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"China","full_name":"Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Alimentiv B.V.","duties_or_roles":"MRE and IUS analysis, endpoint tests","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"codes: 1,12,2,5,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Patient Reported Outcomes and eDiary","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Guselkumab- Solution for infusion- 10 mg/ml
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorized
- Investigational Product Name
- Guselkumab
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorized
- Investigational Product Name
- Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorized
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