A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
NCT ID: NCT06260163
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2024-01-19
2028-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Open-label Induction Phase: Guselkumab Intravenously (IV)
Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase.
Guselkumab Intravenous
Guselkumab will be administered intravenously.
Open-label Induction Phase: Guselkumab Subcutaneously (SC)
Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase.
Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Double-blind Maintenance Phase: Guselkumab Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56.
Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Double-blind Maintenance Phase: Guselkumab Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56.
Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Open-label Maintenance Phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56.
Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Interventions
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Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Guselkumab Intravenous
Guselkumab will be administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
* Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore \>= 2 as determined by a central review of the video of the endoscopy
* Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
* Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
Exclusion Criteria
* Presence of a stoma
* Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
* Have severe colitis or have evidence of Crohn's Disease (CD)
2 Years
17 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Children's Hospital Oakland
Oakland, California, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
NYU Langone Health
Lake Success, New York, United States
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Nedlands, , Australia
Mater Hospital Brisbane Inflammatory Bowel Diseases
South Brisbane, , Australia
The Children's Hospital at Westmead
Westmead, , Australia
CHU Charleroi Chimay
Charleroi, , Belgium
UZ Gent
Ghent, , Belgium
UZ Brussel
Jette, , Belgium
UZ Leuven
Leuven, , Belgium
Capital Center For Children's health Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
Changzhou No 2 Peoples Hospital
Changzhou, , China
The Childrens Hospital Zhejiang University School Of Medicine
Hangzhou, , China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, , China
Ruijin Hospital Shanghai Jiao Tong University
Shanghai, , China
Shengjing Hospital Of China Medical University
Shenyang, , China
Henan Children's Hospital, Zhengzhou Children's Hospital
Zhengzhou, , China
Aarhus Universitetshospital
Aarhus N, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
Bron, , France
Hopital Francois Mitterand
Dijon, , France
CHRU Lille
Lille, , France
APHP Hopital Robert Debre
Paris, , France
CHU Toulouse
Toulouse, , France
ASST Papa Giovanni XXIII Bergamo
Bergamo, , Italy
Azienda USL di Bologna - Ospedale Maggiore
Bologna, , Italy
AOU Meyer
Florence, , Italy
Ospedale S. Spirito, Azienda Sanitaria Pescara
Pescara, , Italy
AOU Policlinico Umberto I
Roma, , Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, , Italy
Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
IRCCS Materno Infantile Burlo Garofolo
Trieste, , Italy
Tokyo Metropolitan Children's Medical Center
Fuchū, , Japan
Kanazawa University Hospital
Kanazawa, , Japan
Kobe University Hospital
Kobe, , Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, , Japan
Shinshu University Hospital
Matsumoto, , Japan
Saga University Hospital
Saga, , Japan
National Center for Child Health and Development
Setagaya Ku, , Japan
Tokyo Medical University Hospital
Shinjuku, , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, , Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, , Japan
Akershus Universitetssykehus
Lørenskog, , Norway
Oslo University Hospital
Oslo, , Norway
Universitetssykehuset Nord-Norge HF
Tromsø, , Norway
St. Olavs Hospital
Trondheim, , Norway
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk, , Poland
Korczowski Bartosz Gabinet Lekarski
Rzeszów, , Poland
Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, , Poland
Uls Santa Maria - Hosp. Santa Maria
Lisbon, , Portugal
Uls Santo Antonio - Cmin
Porto, , Portugal
Uls Sao Joao - Hosp. Sao Joao
Porto, , Portugal
Hosp. Infantil Univ. Nino Jesus
Madrid, , Spain
Corporacio Sanitari Parc Tauli
Sabadell, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, , Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Marmara University Pendik Training Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Other Identifiers
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CNTO1959PUC3001
Identifier Type: OTHER
Identifier Source: secondary_id
2022-001285-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022-502238-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR109251
Identifier Type: -
Identifier Source: org_study_id