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
- Diseases
- Ulcerative colitis
- 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
Sites (61)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Kids Research Institute Australia on behalf of the Centre for Child Health Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| Mater Hospital Brisbane Inflammatory Bowel Diseases Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| ISPPC CHU Charleroi Coordinator of this site? Confirm its status | Charleroi | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Completed |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Completed |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Capital Center For Children's health Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Changzhou No 2 Peoples Hospital Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| The Childrens Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Ruijin Hospital Shanghai Jiao Tong University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Henan Children's Hospital(Zhengzhou Children's Hospital) Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Region Hovedstaden Coordinator of this site? Confirm its status | Hvidovre | Denmark | Completed |
| Hospital Infantil Universitario Nino Jesus Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Hopital Des Enfants Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Azienda Sanitaria Locale di Pescara Coordinator of this site? Confirm its status | Pescara | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Active, not recruiting |
| Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Coordinator of this site? Confirm its status | Trieste | Italy | Active, not recruiting |
| Tokyo Metropolitan Children's Medical Center Coordinator of this site? Confirm its status | Fuchū | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| Kobe University Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Japanese Red Cross Kumamoto Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| Shinshu University Hospital Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Saga University Hospital Coordinator of this site? Confirm its status | Saga | Japan | Unknown status |
| National Center for Child Health and Development Coordinator of this site? Confirm its status | Setagaya-Ku | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Saiseikai Yokohamashi Tobu Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Akershus University Hospital Coordinator of this site? Confirm its status | Loerenskog | Norway | Completed |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Completed |
| Universitetssykehuset Nord-Norge HF Coordinator of this site? Confirm its status | Tromsoe | Norway | Completed |
| St. Olavs hospital HF Coordinator of this site? Confirm its status | Trondheim | Norway | Completed |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Korczowski Bartosz, Gabinet Lekarski Coordinator of this site? Confirm its status | Rzeszów | Poland | Active, not recruiting |
| Instytut Pomnik Centrum Zdrowia Dziecka Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| WIP Warsaw IBD Point Profesor Kierkuś Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Completed |
| Centro Hospitalar Universitario Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Centro Hospitalar Universitário de Santo Antonio,E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Completed |
| Riley Hospital for Children Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Ankara University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gazi University Medical Faculty Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Marmara University Pendik Training Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.