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NCT06260163Active, not recruitingPhase 3

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
112 (actual)
First submitted
7 Feb 2024
Start date
19 Jan 2024
Primary completion date
10 Feb 2027
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT06260163
EU CT number
2022-502238-22-00
EudraCT number
2022-001285-35

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 112
  • From 19 Jan 2024 to the primary completion date, 10 Feb 2027
  • 61 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline

Other illness

  • Have severe colitis or have evidence of Crohn's Disease (CD)

Other

  • Have UC limited to the rectum only or to less than (\<) 20 centimeter of the colon
  • Presence of a stoma

Who the study is looking for

  • Weight greater than or equal to (\>=) 10 kilogram (kg) at the time of consent for screening
  • 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

Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Kids Research Institute Australia on behalf of the Centre for Child Health Research
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Mater Hospital Brisbane Inflammatory Bowel Diseases
Coordinator of this site? Confirm its status
South BrisbaneAustraliaUnknown status
The Children's Hospital at Westmead
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WestmeadAustraliaUnknown status
ISPPC CHU Charleroi
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CharleroiBelgiumCompleted
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Brussel
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JetteBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Peking University Third Hospital
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BeijingChinaUnknown status
Capital Center For Children's health Capital Medical University
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BeijingChinaUnknown status
Changzhou No 2 Peoples Hospital
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ChangzhouChinaUnknown status
The Childrens Hospital, Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Ruijin Hospital Shanghai Jiao Tong University
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Henan Children's Hospital(Zhengzhou Children's Hospital)
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ZhengzhouChinaUnknown status
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Region Hovedstaden
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HvidovreDenmarkCompleted
Hospital Infantil Universitario Nino Jesus
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MadridSpainCompleted
Parc Tauli Hospital Universitari
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SabadellSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire de Dijon
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DijonFranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Hopital Des Enfants
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Toulouse Cedex 9FranceCompleted
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Meyer IRCCS
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FlorenceItalyActive, not recruiting
Azienda Sanitaria Locale di Pescara
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PescaraItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
Bambino Gesu Childrens Hospital
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RomeItalyActive, not recruiting
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyActive, not recruiting
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
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TriesteItalyActive, not recruiting
Tokyo Metropolitan Children's Medical Center
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FuchūJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
Kobe University Hospital
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KobeJapanUnknown status
Japanese Red Cross Kumamoto Hospital
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KumamotoJapanUnknown status
Shinshu University Hospital
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MatsumotoJapanUnknown status
Saga University Hospital
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SagaJapanUnknown status
National Center for Child Health and Development
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Setagaya-KuJapanUnknown status
Tokyo Medical University Hospital
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ShinjukuJapanUnknown status
Osaka Medical and Pharmaceutical University Hospital
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TakatsukiJapanUnknown status
Saiseikai Yokohamashi Tobu Hospital
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YokohamaJapanUnknown status
Akershus University Hospital
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LoerenskogNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
Universitetssykehuset Nord-Norge HF
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TromsoeNorwayCompleted
St. Olavs hospital HF
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TrondheimNorwayCompleted
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandActive, not recruiting
Korczowski Bartosz, Gabinet Lekarski
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RzeszówPolandActive, not recruiting
Instytut Pomnik Centrum Zdrowia Dziecka
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WarsawPolandActive, not recruiting
WIP Warsaw IBD Point Profesor Kierkuś
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WarszawaPolandActive, not recruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalCompleted
Centro Hospitalar Universitario Sao Joao E.P.E.
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PortoPortugalCompleted
Centro Hospitalar Universitário de Santo Antonio,E.P.E.
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PortoPortugalCompleted
Riley Hospital for Children
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IndianapolisUnited StatesUnknown status
NYU Langone Health
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Lake SuccessUnited StatesUnknown status
Children's Hospital Oakland
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OaklandUnited StatesUnknown status
Ankara University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Gazi University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Marmara University Pendik Training Hospital
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IstanbulTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.