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Study identifier: NCT05083182 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: CompletedPSUMMIT-Jr

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

Condition: Arthritis, Juvenile  ·  Sponsor: Janssen Research & Development, LLC

PhasePhase 3
Planned participants48
Who can joinAll sexes, 5 Years to 17 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where50 locations · 10 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (50)

Childrens Hospital Los AngelesLos Angeles, California, United States
UCLALos Angeles, California, United States
Harvard Medical School - Boston Children's HospitalBoston, Massachusetts, United States
Northwell HealthNew York, New York, United States
Montefiore Medical CenterThe Bronx, New York, United States
University of North CarolinaChapel Hill, North Carolina, United States
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio, United States
Legacy Emanuel Medical CenterPortland, Oregon, United States
University of UtahSalt Lake City, Utah, United States
STAT Research S ACiudad Autonoma Buenos Aires, Argentina
Hospital de Ninos de CordobaCórdoba, Argentina
Instituto Medico PlatenseLa Plata, Argentina

+ 38 more locations — full list on the registry record.

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