Psoriasis Clinical Trial
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the pharmacokinetics (PK) and efficacy of ustekinumab and guselkumab in juvenile psoriatic arthritis (jPsA).
Juvenile psoriatic arthritis is a complex, chronic, progressive, debilitating musculoskeletal disease with significant remaining medical need. There is a need for medications which have a similar efficacy profile and a similar safety profile relative to currently available treatment for jPsA which include anti-tumor necrosis factor alpha (TNF alpha) inhibitors (though mostly off-label) and secukinumab. STELARA (ustekinumab) is a fully human immunoglobulin G (IgG) 1 kappa monoclonal antibody (mAb) which binds with high affinity to the p40 subunit common to both interleukin (IL)-12 and IL 23 preventing IL-12/23p40 binding to the IL 12 Rb1 cell surface receptor shared by both cytokines. Through this mechanism of action, ustekinumab effectively neutralizes IL-12 T helper 1- and IL-23 T helper 17-mediated cellular responses. TREMFYA (guselkumab) is a fully human IgG1 lambda (G1 lambda) mAb that binds to the p19 subunit of human IL-23 with high affinity. The binding of guselkumab to IL-23 blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23-specific intracellular signaling and subsequent activation and cytokine production. This study consists of Screening period (up to 6 weeks), Treatment period (up to 52 weeks) and a final safety visit at Week 68. The total duration of the study is up to 68 weeks.
Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made at least 12 weeks 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
Inadequate response (>= 4 weeks) or intolerance to >=1 non-steroidal anti-inflammatory drug (NSAID)
Inadequate response (>=12 weeks) or intolerance to >=1 non-biological disease modifying anti-rheumatic drug (DMARD)
If using corticosteroids; must be on a stable dose of less than or equal to (<=) 10 milligrams (mg) prednisone equivalent or 0.20 mg per kilograms (kg) per day (whichever is less) for >=4 weeks before first administration of study intervention. If currently not using corticosteroids, the participant must have not received corticosteroids (intra articular, intramuscular, or intravenous [IV] corticosteroids [including intramuscular corticotropin]) for >=4 weeks before the first dose administration
Participants with 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
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There are 17 Locations for this study
Los Angeles California, 90027, United States
Bronx New York, 10467, United States
New York New York, 11040, United States
Chapel Hill North Carolina, 27514, United States
Portland Oregon, 97227, United States
Ciudad Autonoma Buenos Aires , C1013, Argentina
Cordoba , 5000, Argentina
La Plata , B1900, Argentina
San Miguel De Tucuman , T4000, Argentina
Berlin , 13353, Germany
Hamburg , 22081, Germany
Sankt Augustin , 53757, Germany
Milano , 20122, Italy
Santiago de Compostela , 15706, Spain
Sevilla , 41010, Spain
Valencia , 46026, Spain
Nottingham , NG7 2, United Kingdom
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