Clinical trial NCT05252533: A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis
Official title: Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Juvenile Psoriatic Arthritis
Psoriasis
Arthritis, Juvenile
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 31
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to (\>=) 5 to less than (\<) 18 years of age, inclusive, with a diagnosis of juvenile psoriatic arthritis (jPsA) (that is, International League Against Rheumatism \[ILAR\] or Vancouver criteria) by qualified health care professional (HCP)
* \>=6 to \<18 years of age, inclusive, with a diagnosis of pediatric psoriasis (PsO) by a qualified HCP
* Initiated ustekinumab treatment \>=16 weeks prior to enrollment and received 3 or more doses of ustekinumab prior to enrollment
* Parent(s) (preferably both if available or as per local requirements) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in informed consent process

Exclusion Criteria:

* Has poor tolerability of venipuncture or lack of adequate venous access for required blood sampling
* Has any condition that, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* If currently enrolled in an investigational study, contact the study responsible physician to discuss eligibility for inclusion in study

Primary outcomes:
measure: Serum Concentration of Ustekinumab
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 20 weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 20 weeks
measure: Number of Participants with Antibodies to Ustekinumab
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Newport Huntington Medical Group
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
state: Illinois
city: Waterford
country: United States
facility: Michigan Dermatology Institute
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Akron
country: United States
facility: Akron Children s Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: Austin
country: United States
facility: Pediatric Rheumatology Consultants of Austin
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: