Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275ISD1001 | Other Identifier | Janssen Research and development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Juvenile Psoriatic Arthritis (jPsA) | Experimental | 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). |
|
| Cohort 2: Pediatric Psoriasis (PsO) | Experimental | Participants (aged >=6 to <18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating HCP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of Ustekinumab | Serum samples will be analyzed to determine concentrations of ustekinumab using a validated, specific, and sensitive immunoassay method. | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 20 weeks |
| Number of Participants with Serious Adverse Events (SAEs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Huntington Medical Group | Huntington Beach | California | 92648 | United States | ||
| Childrens Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41452420 | Derived | Lam E, Berezny K, Bishop CJ, Lomax KG, Liva SG, Brunner HI, Paller AS, Diaz LZ, Lee LW, Rubin C, Carrasco R, Imundo L, Majlessi A, Smith V, Zhang R, Leu JH; U-POPS Study Group. Pharmacokinetics and Safety of Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Results of the Real-World Ustekinumab Pediatric Opportunistic Pharmacokinetics Study (U-POPS). Rheumatol Ther. 2026 Feb;13(1):265-278. doi: 10.1007/s40744-025-00820-3. Epub 2025 Dec 26. |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| Up to 20 weeks |
| Number of Participants with Antibodies to Ustekinumab | Number of participants with antibodies to ustekinumab will be reported. | Up to 16 weeks |
| Los Angeles |
| California |
| 90027 |
| United States |
| Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital | Chicago | Illinois | 60611-2991 | United States |
| Michigan Dermatology Institute | Waterford | Michigan | 48328 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Akron Children s Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Pediatric Rheumatology Consultants of Austin | Austin | Texas | 78757 | United States |
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided