Clinical trial • Phase III • Immunology|Gastroenterology
GUSELKUMAB for Crohn's disease
Phase III trial of GUSELKUMAB for Crohn's disease. Randomised, placebo for guselkumab (placebo)-controlled. 291 participants.
Overview
- Trial Therapeutic Area
- Immunology|Gastroenterology
- Trial Disease
- Crohn's disease
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 17-06-2024
- First CTIS Authorization Date
- 18-07-2024
Trial design
Randomised, placebo for guselkumab (placebo)-controlled Phase III trial across 31 sites in Italy, Spain, Lithuania and others.
- Randomised
- Yes
- Comparator
- Placebo for Guselkumab (Placebo)
- Target Sample Size
- 291
Eligibility
Recruits 291 Vulnerable population selected. Multiple subject information and informed consent forms are provided (country- and language-specific ICFs are present in the documents list, including ICFs for pregnant partners and child follow-up). Consent is obtained via the provided ICF documents; no explicit text about assent or parental consent handling is available in the provided data..
- Vulnerable Population
- Vulnerable population selected. Multiple subject information and informed consent forms are provided (country- and language-specific ICFs are present in the documents list, including ICFs for pregnant partners and child follow-up). Consent is obtained via the provided ICF documents; no explicit text about assent or parental consent handling is available in the provided data.
Inclusion criteria
- {"criterion_text":"- Clinically active Crohn's disease or fistulizing Crohn's disease of at least 3 months duration\n- Endoscopic evidence of active ileocolonic Crohn's disease\n- Current treatment with oral corticosteroids and/or immunomodulators, OR history of failure to respond to or tolerate oral corticosteroids and/or immunomodulators, OR history of corticosteroid dependence, OR has previously demonstrated lack of initial response, lost response or were intolerant to 1 or more biologic agents."}
Exclusion criteria
- {"criterion_text":"- Has a draining stoma or ostomy.\n- Presence on screening endoscopy or history of adenomatous colonic polyps that were not removed.\n- Has previously received a biologic agent targeting IL-12/23 or IL-23."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical remission at Week 12\n- Endoscopic response at Week 12","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 291
- Recruitment Window Months
- 68
- Consent Approach
- Informed consent is obtained via subject information and informed consent forms (multiple L1_ICF documents are listed). Country- and language-specific ICFs are provided (examples in the document list include Lithuanian, Russian, Croatian, Czech, Hungarian and English versions). There are also specific ICF documents for pregnant partners and child follow-up. No further details of assent or the consent-signing process are provided in the available data.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 219
Italy
- Latest Decision Or Authorization Date
- 29-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- IT10011:Gastroenterologia ed Endoscopia digestiva
- Contact Person Name
- Silvio Danese
- Contact Person Email
- danese.silvio@hsr.it
- Site Name
- Universita' Campus Bio-medico Di Roma
- Department Name
- IT10001:UOC di Gastroenterologia
- Contact Person Name
- Michele Cicala
- Contact Person Email
- m.cicala@policlinicocampus.it
Spain
- Latest Decision Or Authorization Date
- 19-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- 10008 : Gastroenterologia
- Contact Person Name
- Angel Ponferrada Diaz
- Contact Person Email
- angel.ponferrada@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- 10003 : Aparato Digestivo
- Contact Person Name
- Federico Argüelles Arias
- Contact Person Email
- farguelles1@us.es
Lithuania
- Latest Decision Or Authorization Date
- 07-08-2024
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- LT10001:Dept of Gastroenterology
- Contact Person Name
- Laimas Jonaitis
- Contact Person Email
- laimas.jonaitis@lsmuni.lt
France
- Latest Decision Or Authorization Date
- 29-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- FR10006 Hépato-Gastroentérologie
- Contact Person Name
- Stéphane Nancey
- Contact Person Email
- stephane.nancey@chu-lyon.fr
Croatia
- Latest Decision Or Authorization Date
- 18-07-2024
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- HR10003; Gastroenterology
- Contact Person Name
- Dominik Kralj
- Contact Person Email
- dominik.rex@gmail.com
Czechia
- Latest Decision Or Authorization Date
- 23-07-2024
- Number Of Sites
- 3
- Number Of Participants
- 17
Sites
- Site Name
- Oblastní nemocnice Kladno, a.s.
- Department Name
- CZ10005:Gastroenterologicke a endoskopicke centrum
- Contact Person Name
- Helena Hlavova
- Contact Person Email
- hhlavova@atlas.cz
- Site Name
- Nemocnice Slany
- Department Name
- CZ10006:Gastroenterologicko-endoskopicke oddeleni
- Contact Person Name
- Martin Peterka
- Contact Person Email
- peterka.studie@seznam.cz
- Site Name
- Vojenska Nemocnice Brno
- Department Name
- CZ10001:Interni oddeleni
- Contact Person Name
- David Stepek
- Contact Person Email
- dstepek@vnbrno.cz
Poland
- Latest Decision Or Authorization Date
- 04-08-2024
- Number Of Sites
- 15
- Number Of Participants
- 134
Sites
- Site Name
- Sonomed Sp. z o.o.
- Department Name
- PL10050_Gastroenterology
- Contact Person Name
- Anna Wiechowska - Kozlowska
- Contact Person Email
- anna.kozlowska@sonomedszczecin.pl
- Site Name
- Melita Medical Sp. z o.o.
- Department Name
- PL10040_Melita Medical
- Contact Person Name
- Jaroslaw Leszczyszyn
- Contact Person Email
- j.leszczyszyn@melitamedical.pl
- Site Name
- Pro Life Medica Sp. z o.o.
- Department Name
- PL10045_ETG Zamosc
- Contact Person Name
- Katarzyna Wojcik
- Contact Person Email
- k.wojcik@etg-network.com
- Site Name
- Wojewodzki Szpital Specjalistyczny W Olsztynie
- Department Name
- PL10021_Oddzial Gastroenterologiczny
- Contact Person Name
- Tomasz Arlukowicz
- Contact Person Email
- tarlukowicz@wss.olsztyn.pl
- Site Name
- Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
- Department Name
- PL10031_NZOZ „Centrum Medyczne KERMED"
- Contact Person Name
- Patryk Korga
- Contact Person Email
- patryk.korga@kermed.pl
- Site Name
- Bodyclinic Sp. z o.o. sp.k.
- Department Name
- PL10047_Gastroenterology
- Contact Person Name
- Piotr Gietka
- Contact Person Email
- piotrgietka@gmail.com
- Site Name
- Reumed Sp. z o.o.
- Department Name
- PL10019_REUMED Zespol Poradni Specjalistycznych Filia nr 2
- Contact Person Name
- Wit Danilkiewicz
- Contact Person Email
- wdanilk@gmail.com
- Site Name
- H-T.Centrum Medyczne Sp. z o.o. sp.k.
- Department Name
- PL10057_H-T. CENTRUM MEDYCZNE - ENDOTERAPIA
- Contact Person Name
- Tomasz Romanczyk
- Contact Person Email
- romanczyk@htcentrum.pl
- Site Name
- Centrum Medyczne Lukamed Sp. z o.o.
- Department Name
- PL10056_Centrum Medyczne Lukamed
- Contact Person Name
- Dariusz Gajda
- Contact Person Email
- dariuszgajda@lukamed.com
- Site Name
- Vivamed Sp. z o.o.
- Department Name
- PL10055_Gastroenterology
- Contact Person Name
- Robert Petryka
- Contact Person Email
- robert@petrykamed.com
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- PL10022_Twoja Przychodnia SCM
- Contact Person Name
- Beata Gawdis - Wojnarska
- Contact Person Email
- gawdis@twojaprzychodnia.com
- Site Name
- Centrum Medyczne Medyk Sp. z o.o.
- Department Name
- PL10023_Gastroenterology
- Contact Person Name
- Rafal Filip
- Contact Person Email
- r.s.filip@wp.pl
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Department Name
- PL10043_Centrum Medyczne Plejady
- Contact Person Name
- Monika Augustyn
- Contact Person Email
- amonika@interia.pl
- Site Name
- Centrum Medyczne Med-Gastr Sp. z o.o.
- Department Name
- PL10063_Gastroenterology
- Contact Person Name
- Arkadiusz Mamos
- Contact Person Email
- arkadiusz.mamos@medgastr.pl
Slovakia
- Latest Decision Or Authorization Date
- 19-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Endomed s.r.o.
- Department Name
- SK10003: Gastroenterologicka ambulancia
- Contact Person Name
- Miroslav Fedurco
- Contact Person Email
- fedurco@endomed.sk
- Site Name
- Gastro I. s.r.o.
- Department Name
- SK10004: Gastroenterologicka ambulacia
- Contact Person Name
- Bohus Bunganic
- Contact Person Email
- gastrobunganic@gmail.com
Hungary
- Latest Decision Or Authorization Date
- 18-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Semmelweis University
- Department Name
- HU10008; Belgyógyászati és Haematológiai Klinika
- Contact Person Name
- Emese Mihaly
- Contact Person Email
- emesemihaly@hotmail.com
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Department Name
- HU10006
- Contact Person Name
- Csaba Fülöp
- Contact Person Email
- csaba.fulop@oec.hu
Germany
- Latest Decision Or Authorization Date
- 24-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- MVZ Dachau
- Department Name
- 10020 : Endoscopy
- Contact Person Name
- Wilfred Landry
- Contact Person Email
- landry@dachau-med.de
- Site Name
- CED-Studienzentrum Karlshorst
- Department Name
- 10012; Gastroenterologie
- Contact Person Name
- Thomas Brunk
- Contact Person Email
- thomas.brunk@gastroenterologie-brunk.de
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 1,12,2,6,9
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: 7
- Name
- Reify Health Inc.
- Responsibilities
- sponsorDuties codes: 2
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sponsorDuties codes: 3
- Name
- Bioclinica Inc.
- Responsibilities
- Central Imaging Services (sponsorDuties code: 15) and code 7
- Name
- Eresearchtechnology Inc.
- Responsibilities
- ePRO (sponsorDuties codes: 15,7)
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Clinical chemistry and haematology, Histopathology, Serology/ endocrinology (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Reify Health Inc.","duties_or_roles":"sponsorDuties code: 2","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Clinical chemistry and haematology, Histopathology, Serology/ endocrinology (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Histopathology (sponsorDuties code: 15)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Imaging Services (sponsorDuties codes: 15,7)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO (sponsorDuties codes: 15,7)","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,12,2,6,9","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (prodAuthStatus: 1)
- Investigational Product Name
- Placebo for Guselkumab
- Modality
- Other
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