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NCT05083182CompletedPhase 3

A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis

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)

Source: ClinicalTrials.gov · Last updated 31 Jul 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
48 (actual)
First submitted
8 Oct 2021
Start date
30 Aug 2022
Primary completion date
12 Jan 2026
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT05083182
EU CT number
2023-507144-36-00
EudraCT number
2020-005503-40

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 48
  • From 30 Aug 2022 to the primary completion date, 12 Jan 2026
  • 50 sites in 11 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

  • Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
  • Has evidence of herpes zoster infection within 8 weeks prior to Week 0

Other illness

  • Have a history of, or ongoing, chronic or recurrent infectious disease
  • Have a known history of hepatitis C infection or test positive at screening

Other

  • Participants with enthesitis-related arthritis (ERA)

Who the study is looking for

  • Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made \>=3 months (that is, 90 days) prior to screening
  • Active disease in at least greater than or equal to (\>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
  • Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
  • Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
  • Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
  • Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period

Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (50)

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

SiteCityCountrySite status
STAT Research S.A.
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Hospital de Ninos de Cordoba
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CórdobaArgentinaUnknown status
Instituto Médico Platense
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La PlataArgentinaUnknown status
Instituto CAICI
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RosarioArgentinaUnknown status
Centro Medico Privado de Reumatologia
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San Miguel de TucumánArgentinaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyCompleted
Schoen Klinik Hamburg Eilbek
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HamburgGermanyCompleted
Asklepios-Klinik, Sankt Augustin GmbH
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Sankt AugustinGermanyCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Odense University Hospital
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Odense CDenmarkCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital General Universitario Reina Sofia
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CórdobaSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainCompleted
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Bicetre Hospital
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Le Kremlin Bicetre CedexFranceCompleted
Centre Hospitalier Regional De Marseille
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MarseilleFranceCompleted
Hopital Des Enfants
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Toulouse Cedex 9FranceCompleted
CHRU De Nancy
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Vandoeuvre Les NancyFranceCompleted
Great Ormond Street Hospital
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LondonUnited KingdomUnknown status
Royal Manchester Children's Hospital
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ManchesterUnited KingdomUnknown status
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomUnknown status
Nottingham University Hospitals NHS Trust
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NottinghamUnited KingdomUnknown status
Sheffield Children's Hospital
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SheffieldUnited KingdomUnknown status
Southampton General Hospital
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SouthamptonUnited KingdomUnknown status
Haywood Hospital
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StaffordshireUnited KingdomUnknown status
Royal Stoke University Hospital
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Stoke-on-TrentUnited KingdomUnknown status
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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BresciaItalyCompleted
IRCCS Istituto Giannina Gaslini
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GenoaItalyCompleted
Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto
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MilanItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Ospedale Pediatrico Bambino Gesù
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RomeItalyCompleted
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsCompleted
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
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LodzPolandCompleted
Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o
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SosnowiecPolandCompleted
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
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WarsawPolandCompleted
Harvard Medical School - Boston Children's Hospital
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BostonUnited StatesUnknown status
University of North Carolina
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Chapel HillUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Childrens Hospital Los Angeles
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Los AngelesUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
Northwell Health
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New YorkUnited StatesUnknown status
Legacy Emanuel Medical Center
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PortlandUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Hacettepe Üniversitesi Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
Istanbul University Cerrahpasa Medical Faculty
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IstanbulTurkey (Türkiye)Unknown status
Ümraniye Training and Research Hospital
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IstanbulTurkey (Türkiye)Unknown status
Kocaeli University Medical Faculty
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KocaeliTurkey (Türkiye)Unknown status

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