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A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Janssen Research & Development, LLC
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2024-01-19
Completion Date
2028-08-14
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Guselkumab Subcutaneous
Guselkumab will be administered subcutaneously.
Guselkumab Intravenous
Guselkumab will be administered intravenously.
Locations (61)
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)