A Phase 1 interventional study of Ustekinumab in Juvenile Psoriatic Arthritis, Psoriasis and Arthritis, Juvenile, sponsored by Janssen Research & Development, LLC. Completed at 10 sites in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other
The purpose of the study is to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO).
jPsA 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 well-characterized safety profile relative to currently available tumor necrosis factor alpha (TNF alpha) inhibitors for jPsA participants with active disease. STELARA (ustekinumab) is a fully human immunoglobulin G1 kappa monoclonal antibody 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. Ustekinumab has been extensively studied in adult participants with psoriasis, psoriatic arthritis (PsA), Crohn's disease, and ulcerative colitis (UC). Additionally, ustekinumab has been studied in children (greater than or equal to [>=] 6 to less than [\<] 12 years of age) and adolescents (>=12 to \<18 years of age) with pediatric psoriasis [PsO]. This study consists of 3 visits: screening (Visit 1), interim and final visit (Visits 2 and 3) (Visits should be >=7 days apart). Key safety assessments include analyses of the incidence and types of adverse events (AEs), serious adverse events (SAEs), reasonably related AEs, and discontinuation of ustekinumab due to an AE, infections, and/or injection site and hypersensitivity reactions. Any newly identified malignancy, case of active tuberculosis (TB), or opportunistic infection will also be assessed. The total duration of the study is up to 20 weeks.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 31 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants (aged greater than or equal to \[\>=\] 5 to less than \[\<\] 18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating health care professional (HCP).
Drug: Ustekinumab
Participants (aged \>=6 to \<18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating HCP.
Drug: Ustekinumab
This study does not provide dosing instructions for ustekinumab but will engage participants who have been treated with ustekinumab by their corresponding HCPs independent of this study.
Also known as: STELARA
Serum Concentration of Ustekinumab
Serum samples will be analyzed to determine concentrations of ustekinumab using a validated, specific, and sensitive immunoassay method.
Time frame: Up to 16 weeks
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 20 weeks
Number of Participants with Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Time frame: Up to 20 weeks
Number of Participants with Antibodies to Ustekinumab
Number of participants with antibodies to ustekinumab will be reported.
Time frame: Up to 16 weeks
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Janssen Research & Development, LLC