Clinical trial • Phase III • Immunology|Gastroenterology
GUSELKUMAB for Ulcerative colitis|Moderately to severely active ulcerative colitis
Phase III trial of GUSELKUMAB for Ulcerative colitis|Moderately to severely active ulcerative colitis.
Overview
- Trial Therapeutic Area
- Immunology|Gastroenterology
- Trial Disease
- Ulcerative colitis|Moderately to severely active ulcerative colitis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 14-05-2024
- First CTIS Authorization Date
- 18-06-2024
Trial design
Randomised, placebo arms (guselkumab 1 ml pfs placebo; guselkumab 2 ml pfs placebo) compared with guselkumab (investigational product listed as guselkumab; product listing includes 'guselkumab - solution for injection in pre-filled syringe - 100 mg/ml'). specific dose and schedule details are not provided in the json.-controlled Phase III trial across 33 sites in Slovakia, Czechia, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Placebo arms (Guselkumab 1 mL PFS Placebo; Guselkumab 2 mL PFS Placebo) compared with Guselkumab (investigational product listed as Guselkumab; product listing includes 'Guselkumab - solution for injection in pre-filled syringe - 100 mg/mL'). Specific dose and schedule details are not provided in the JSON.
- Target Sample Size
- 174
Eligibility
Recruits 174 Vulnerable population selection indicated (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms are listed in the documentation, including documents titled for Pregnant Partner and 12 months infant follow-up (e.g., "REDACTED_L1_SIS and ICF Pregnant Partner", "REDACTED_L1_SIS and ICF 12 months infant follow-up"). Informed consent appears to be obtained via country-specific SIS/ICF documents in multiple languages; partner/infant follow-up ICFs are provided, indicating additional consent processes for partners/infant follow-up where applicable..
- Vulnerable Population
- Vulnerable population selection indicated (populationOfTrialSubjects.isVulnerablePopulationSelected = true). Country-specific subject information and informed consent forms are listed in the documentation, including documents titled for Pregnant Partner and 12 months infant follow-up (e.g., "REDACTED_L1_SIS and ICF Pregnant Partner", "REDACTED_L1_SIS and ICF 12 months infant follow-up"). Informed consent appears to be obtained via country-specific SIS/ICF documents in multiple languages; partner/infant follow-up ICFs are provided, indicating additional consent processes for partners/infant follow-up where applicable.
Inclusion criteria
- {"criterion_text":"- Documented diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline.\n- Moderately to severely active UC as assessed by the modified mayo score\n- Demonstraed inadequate response to or intolerance of conventional (ie, 6-MP, AZA, or corticosteroids) or advanced therapy (ADT; ie, TNFα antagonists, vedolizumab, ozanimod, or approved JAK inhibitors)."}
Exclusion criteria
- {"criterion_text":"- 1.Has severe extensive colitis as defined in the protocol\n- 2.Extent of inflammatory disease limited to the rectum\n- 3.Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD)\n- 4.Has a history of, or ongoing, chronic or recurrent infectious disease\n- 5.Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 weeks prior to first dose of study intervention)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Clinical remission (at week 12)","definition_or_measurement_approach":"Assessed at week 12. Disease activity in the trial is evaluated using the modified Mayo score (modified mayo score referenced elsewhere in eligibility criteria); no further formal definition of 'clinical remission' is provided in the JSON."}
Recruitment
- Planned Sample Size
- 174
- Recruitment Window Months
- 62
- Consent Approach
- Informed consent is managed via country-specific Subject Information Sheets and Informed Consent Forms (numerous SIS/ICF documents are listed by country and language). There are ICF documents for main consent, pregnant partner ICFs, and 12-month infant follow-up ICFs, indicating age- or role-specific consent documents. Multiple language versions are available (document titles include language identifiers such as EN, CZ, BG, DE, ES, PL, FR, HU). CTIS public/scientific contact for the sponsor is provided (functionalName 'CTIS Point of Contact', email CTISadmin@its.jnj.com).
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 143
Slovakia
- Latest Decision Or Authorization Date
- 28-02-2025
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Endomed s.r.o.
- Department Name
- Gastroenterologicka ambulancia
- Principal Investigator Name
- Miroslav Fedurco
- Principal Investigator Email
- fedurco@endomed.sk
- Contact Person Name
- Miroslav Fedurco
- Contact Person Email
- fedurco@endomed.sk
- Site Name
- Cliniq s.r.o.
- Department Name
- 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
Czechia
- Latest Decision Or Authorization Date
- 09-09-2025
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Gastroenterologie s.r.o.
- Principal Investigator Name
- Milan Široký
- Principal Investigator Email
- gastro@gastroenterologie-hk.cz
- Contact Person Name
- Milan Široký
- Contact Person Email
- gastro@gastroenterologie-hk.cz
- Site Name
- Nemocnice Ceske Budejovice a.s.
- Department Name
- Gastroenterologické oddělení
- Principal Investigator Name
- Martin Bortlík
- Principal Investigator Email
- borlik.martin@nemcb.cz
- Contact Person Name
- Martin Bortlík
- Contact Person Email
- borlik.martin@nemcb.cz
- Site Name
- Axon Clinical s.r.o.
- Principal Investigator Name
- Jan Matouš
- Principal Investigator Email
- jan.matous@axon-clinical.com
- Contact Person Name
- Jan Matouš
- Contact Person Email
- jan.matous@axon-clinical.com
Bulgaria
- Latest Decision Or Authorization Date
- 15-09-2025
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Medical center Asclepion humane medicine researches EOOD
- Principal Investigator Name
- Rayna Draganova
- Principal Investigator Email
- drdraganova@abv.bg
- Contact Person Name
- Rayna Draganova
- Contact Person Email
- drdraganova@abv.bg
- Site Name
- Diagnostics And Consultation Center Convex Ltd.
- Principal Investigator Name
- Ludmila Tankova
- Principal Investigator Email
- drtankova@abv.bg
- Contact Person Name
- Ludmila Tankova
- Contact Person Email
- drtankova@abv.bg
Germany
- Latest Decision Or Authorization Date
- 09-09-2025
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Medizinisches Versorgungszentrum (MVZ) Dachau
- Department Name
- Medizinisches Versorgungszentrum (MVZ) Dachau
- Principal Investigator Name
- Wilfred Landry
- Principal Investigator Email
- kontakt@dachau-med.de
- Contact Person Name
- Wilfred Landry
- Contact Person Email
- kontakt@dachau-med.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik fur 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
Spain
- Latest Decision Or Authorization Date
- 09-09-2025
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Gastroenterology Service
- Principal Investigator Name
- Federico Arguelles Arias
- Principal Investigator Email
- farguelles@telefonica.net
- Contact Person Name
- Federico Arguelles Arias
- Contact Person Email
- farguelles@telefonica.net
- Site Name
- Hospital Marina Baixa De La Vila Joiosa
- Department Name
- Gastroenterology Service
- Principal Investigator Name
- Antonio García Herola
- Principal Investigator Email
- agherola@gmail.com
- Contact Person Name
- Antonio García Herola
- Contact Person Email
- agherola@gmail.com
Poland
- Latest Decision Or Authorization Date
- 12-09-2025
- Number Of Sites
- 13
- Number Of Participants
- 93
Sites
- Site Name
- Gastromed Sp. z o.o.
- Department Name
- Gastromed Sp. z o.o.
- Principal Investigator Name
- Adam Kopon
- Principal Investigator Email
- gastromedtorun@gmail.com
- Contact Person Name
- Adam Kopon
- Contact Person Email
- gastromedtorun@gmail.com
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia - SCM
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- scm@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- scm@twojaprzychodnia.com
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
- Principal Investigator Name
- Jaroslaw Kierkus
- Principal Investigator Email
- wip@wip.waw.pl
- Contact Person Name
- Jaroslaw Kierkus
- Contact Person Email
- wip@wip.waw.pl
- Site Name
- Centrum Medyczne Lukamed Sp. z o.o.
- Department Name
- Centrum Medyczne LukaMed
- Principal Investigator Name
- Artur Soltysiak
- Principal Investigator Email
- joannaluka@lukamed.com
- Contact Person Name
- Artur Soltysiak
- Contact Person Email
- joannaluka@lukamed.com
- Site Name
- Centrum Medyczne Lukamed Sp. z o.o.
- Department Name
- Centrum Medyczne LukaMed
- Principal Investigator Name
- Dariusz Gajda
- Principal Investigator Email
- dariuszgajda@lukamed.com
- Contact Person Name
- Dariusz Gajda
- Contact Person Email
- dariuszgajda@lukamed.com
- Site Name
- Bodyclinic Sp. z o.o. sp.k.
- Department Name
- Bodyclinic Sp. z o.o. Sp. k.
- Principal Investigator Name
- Piotr Gietka
- Principal Investigator Email
- kontakt@bodyclinic.pl
- Contact Person Name
- Piotr Gietka
- Contact Person Email
- kontakt@bodyclinic.pl
- Site Name
- Melita Medical Sp. z o.o.
- Department Name
- Centrum Medyczne MELITA MEDICAL
- Principal Investigator Name
- Jaroslaw Leszczyszyn
- Principal Investigator Email
- b.lapuszynski@melitamedical.pl
- Contact Person Name
- Jaroslaw Leszczyszyn
- Contact Person Email
- b.lapuszynski@melitamedical.pl
- Site Name
- Gastromed Kralisz Romatowski Stachurska Sp. j.
- Department Name
- Gastromed Kralisz Romatowski Stachurska Sp. j.
- Principal Investigator Name
- Jacek Romatowski
- Principal Investigator Email
- biuro@gastromed.info
- Contact Person Name
- Jacek Romatowski
- Contact Person Email
- biuro@gastromed.info
- Site Name
- Pro Life Medica Sp. z o.o.
- Department Name
- Pro Life Medica Sp z o o ETG Zamosc
- Principal Investigator Name
- Katarzyna Wojcik
- Principal Investigator Email
- zamosc@etg-network.com
- Contact Person Name
- Katarzyna Wojcik
- Contact Person Email
- zamosc@etg-network.com
- Site Name
- Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
- Department Name
- Centrum Medyczne Plejady
- Principal Investigator Name
- Monika Augustyn
- Principal Investigator Email
- trials@plejady.com.pl
- Contact Person Name
- Monika Augustyn
- Contact Person Email
- trials@plejady.com.pl
- Site Name
- Promed P.Lach R.Glowacki Sp. j.
- Department Name
- Centrum Medyczne PROMED
- Principal Investigator Name
- Danuta Owczarek
- Principal Investigator Email
- badania.kliniczne@cmpromed.pl
- Contact Person Name
- Danuta Owczarek
- Contact Person Email
- badania.kliniczne@cmpromed.pl
- Site Name
- Centrum Medyczne Medyk Sp. z o.o. S.K.
- Department Name
- Centrum Medyczne Medyk
- Principal Investigator Name
- Rafal Filip
- Principal Investigator Email
- badaniakliniczne.rejtana@medyk.rzeszow.pl
- Contact Person Name
- Rafal Filip
- Contact Person Email
- badaniakliniczne.rejtana@medyk.rzeszow.pl
- Site Name
- Vistamed & Vertigo Sp. z o.o.
- Department Name
- Vistamed & Vertigo Sp. z o.o.
- Principal Investigator Name
- Bernadeta Frysna
- Principal Investigator Email
- m.szewczuk@vistamed.pl
- Contact Person Name
- Bernadeta Frysna
- Contact Person Email
- m.szewczuk@vistamed.pl
Belgium
- Latest Decision Or Authorization Date
- 08-09-2025
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- CHU Saint Pierre
- Department Name
- Hépato-Gastro-Entérologie
- Principal Investigator Name
- Vinciane Muls
- Principal Investigator Email
- vinciane.muls@stpierre-bru.be
- Contact Person Name
- Vinciane Muls
- Contact Person Email
- vinciane.muls@stpierre-bru.be
France
- Latest Decision Or Authorization Date
- 03-10-2025
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hepato Gastroenterology Department
- Principal Investigator Name
- David LAHARIE
- Principal Investigator Email
- david.laharie@chu-bordeaux.fr
- Contact Person Name
- David LAHARIE
- Contact Person Email
- david.laharie@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hepato Gastroenterology Department
- Principal Investigator Name
- Cyrielle GILLETTA DE SAINT-JOSEPH
- Principal Investigator Email
- gilletta.c@chu-toulouse.fr
- Contact Person Name
- Cyrielle GILLETTA DE SAINT-JOSEPH
- Contact Person Email
- gilletta.c@chu-toulouse.fr
- Site Name
- Nouvelles Cliniques Nimoises
- Department Name
- Hepato Gastroenterology Department
- Principal Investigator Name
- Florent GONZALEZ
- Principal Investigator Email
- secretariat@gastromeridien.fr
- Contact Person Name
- Florent GONZALEZ
- Contact Person Email
- secretariat@gastromeridien.fr
- Site Name
- CHRU De Nancy
- Department Name
- Hepato Gastroenterology Department
- 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
- Site Name
- Centre Medico Chirurgical Ambroise Pare Hartmann
- Department Name
- Institut des MICI
- Principal Investigator Name
- Yoram BOUHNIK
- Principal Investigator Email
- yoram.bouhnik@institutdesmici.fr
- Contact Person Name
- Yoram BOUHNIK
- Contact Person Email
- yoram.bouhnik@institutdesmici.fr
Hungary
- Latest Decision Or Authorization Date
- 09-10-2025
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Semmelweis University
- Department Name
- Gasztroenterológia
- Principal Investigator Name
- Pál Miheller
- Principal Investigator Email
- pmiheller@gmail.com
- Contact Person Name
- Pál Miheller
- Contact Person Email
- pmiheller@gmail.com
- Site Name
- Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
- Department Name
- Gasztroenterológia
- Principal Investigator Name
- Gyula G.Kiss
- Principal Investigator Email
- gkissgyula@gmail.com
- Contact Person Name
- Gyula G.Kiss
- Contact Person Email
- gkissgyula@gmail.com
- Site Name
- Semmelweis University
- Department Name
- Gasztroenterológia
- Principal Investigator Name
- Emese Mihály
- Principal Investigator Email
- emesemihaly@hotmail.com
- Contact Person Name
- Emese Mihály
- Contact Person Email
- emesemihaly@hotmail.com
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
- Name
- Iqvia Rds Inc.
- Responsibilities
- Country level study set-up, country and site management, local regulatory submissions
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- Treatment randomisation
Third parties
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"Histopathology","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging Vendor","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Sample management sercies and forwarding shipment to other labs/Janssen facilities","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"Treatment randomisation","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"eCOA","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"Country level study set-up, country and site management, local regulatory submissions","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Guselkumab
- Active Substance
- GUSELKUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- Subcutaneous
- Authorisation Status
- 1
- 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
- 1
- Investigational Product Name
- Guselkumab 1 mL PFS Placebo
- Modality
- Other
- Investigational Product Name
- Guselkumab 2 mL PFS Placebo
- Modality
- Other
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