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
- Diseases
- Psoriatic arthritis
- 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
Sites (50)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| STAT Research S.A. Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| Hospital de Ninos de Cordoba Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Instituto Médico Platense Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| Instituto CAICI Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro Medico Privado de Reumatologia Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Schoen Klinik Hamburg Eilbek Coordinator of this site? Confirm its status | Hamburg | Germany | Completed |
| Asklepios-Klinik, Sankt Augustin GmbH Coordinator of this site? Confirm its status | Sankt Augustin | Germany | Completed |
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital General Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Bicetre Hospital Coordinator of this site? Confirm its status | Le Kremlin Bicetre Cedex | France | Completed |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Hopital Des Enfants Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Completed |
| CHRU De Nancy Coordinator of this site? Confirm its status | Vandoeuvre Les Nancy | France | Completed |
| Great Ormond Street Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Royal Manchester Children's Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Nottingham University Hospitals NHS Trust Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Sheffield Children's Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Southampton General Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Haywood Hospital Coordinator of this site? Confirm its status | Staffordshire | United Kingdom | Unknown status |
| Royal Stoke University Hospital Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| IRCCS Istituto Giannina Gaslini Coordinator of this site? Confirm its status | Genoa | Italy | Completed |
| Asst Centro Specialistico Ortopedico Traumatologico Gaetano Pini Cto Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale Pediatrico Bambino Gesù Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Completed |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o Coordinator of this site? Confirm its status | Sosnowiec | Poland | Completed |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Harvard Medical School - Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Childrens Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Legacy Emanuel Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Hacettepe Üniversitesi Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Istanbul University Cerrahpasa Medical Faculty Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Ümraniye Training and Research Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Kocaeli University Medical Faculty Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.