A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
NCT ID: NCT05083182
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
48 participants
INTERVENTIONAL
2022-08-30
2027-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Ustekinumab
Participants will receive a weight-based dose of ustekinumab subcutaneously (SC) at Week 0, Week 4 and then every 12 weeks up to Week 52. Cohort 1 is closed for further enrollment.
Ustekinumab
Ustekinumab will be administered as subcutaneous injection.
Cohort 2: Guselkumab
The dose of guselkumab will be based on the participant's weight. Participants will receive guselkumab SC at Weeks 0 and 4 followed by either every 4 weeks (Q4W) (with historical radiographic evidence of joint damage) or every 8 weeks (Q8W) (without historical evidence of joint damage) dosing with the last dose at Week 52. Participants at high risk of joint damage can also be considered for Q4W dosing per investigator.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Interventions
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Ustekinumab
Ustekinumab will be administered as subcutaneous injection.
Guselkumab
Guselkumab will be administered as subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
* Have a history of, or ongoing, chronic or recurrent infectious disease
* Has evidence of herpes zoster infection within 8 weeks prior to Week 0
* Have a known history of hepatitis C infection or test positive at screening
5 Years
17 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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Other Identifiers
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CNTO1275JPA3001
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005503-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR109101
Identifier Type: -
Identifier Source: org_study_id