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

Completed · Phase 3

Conditions studied: Arthritis, Juvenile

In brief

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).

Key facts

Study ID: NCT05083182
Run by: Janssen Research & Development, LLC
People needed: 48
Starts: 2022-08-30
Expected to finish: 2026-06-23
Last updated by the study team: 2026-07-31

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Participants with enthesitis-related arthritis (ERA)
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

Where it is running

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

Full record on ClinicalTrials.gov

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