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A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
Sponsor: Janssen Research & Development, LLC
Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
Official title: A Phase 3 Multicenter, Open-label Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of Subcutaneously Administered Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PSUMMIT-Jr)
Key Details
Gender
All
Age Range
5 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-08-30
Completion Date
2026-12-05
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Ustekinumab
Ustekinumab will be administered as subcutaneous injection.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Locations (50)
Childrens Hospital Los Angeles
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Harvard Medical School - Boston Children's Hospital
Boston, Massachusetts, United States
Northwell Health
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Legacy Emanuel Medical Center
Portland, Oregon, United States
University of Utah
Salt Lake City, Utah, United States
STAT Research S A
Ciudad Autonoma Buenos Aires, Argentina
Hospital de Ninos de Cordoba
Córdoba, Argentina
Instituto Medico Platense
La Plata, Argentina
Instituto Caici
Rosario, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Argentina
Aarhus Universitetshospital
Aarhus, Denmark
Odense Universitets Hospital
Odense, Denmark
CHU de Caen
Caen, France
Hopital de Bicetre
Le Kremlin-Bicêtre, France
Hopital Nord Marseille
Marseille, France
CHU de Toulouse Hopital des Enfants
Toulouse, France
Hôpital D'Enfants
Vandœuvre-lès-Nancy, France
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany
Schon Klinik Hamburg Eilbek
Hamburg, Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin, Germany
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili
Brescia, Italy
Istituto Giannina Gaslini
Genova, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini CTO
Milan, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej
Lodz, Poland
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
Sosnowiec, Poland
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, Poland
Hosp Univ Vall D Hebron
Barcelona, Spain
Hosp. de La Santa Creu I Sant Pau
Barcelona, Spain
Hosp Reina Sofia
Córdoba, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain
Hosp. Infanta Luisa
Seville, Spain
Hosp. Univ. I Politecni La Fe
Valencia, Spain
Hacettepe Universitesi Hastanesi
Ankara, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty
Istanbul, Turkey (Türkiye)
Umraniye Training and Research Hospital
Istanbul, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, Turkey (Türkiye)
Great Ormond Street Hospital
London, United Kingdom
Royal Manchester Children's Hospital
Manchester, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Sheffield Children's Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Haywood Hospital
Staffordshire, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom