A Study of Ustekinumab in Pediatric Participants (U-POPS) With Juvenile Psoriatic Arthritis or Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-24

Study Completion Date

2024-01-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age

NCT02698475

Psoriasis

COMPLETED PHASE3

A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

NCT03218488

Psoriasis

ACTIVE_NOT_RECRUITING

Safety and Efficacy of Ustekinumab in Patients With Palmo-Plantar Pustular Psoriasis or With Palmo-Plantar Pustulosis

NCT01091051

Palmo-Plantar Pustular Psoriasis Palmo-Plantar Pustulosis

TERMINATED PHASE3

A Study of the Safety and Efficacy of Ustekinumab in Patients With Psoriatic Arthritis With and Without Prior Exposure to Anti-TNF Agents

NCT01077362

Arthritis, Psoriatic

COMPLETED PHASE3

An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis

NCT00723528

Psoriasis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Juvenile Psoriatic Arthritis Psoriasis Arthritis, Juvenile

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1: Juvenile Psoriatic Arthritis (jPsA)

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).

Group Type EXPERIMENTAL

Ustekinumab

Intervention Type 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.

Cohort 2: Pediatric Psoriasis (PsO)

Participants (aged \>=6 to \<18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating HCP.

Group Type EXPERIMENTAL

Ustekinumab

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

STELARA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No