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Juvenile Psoriatic ArthritisPhase 1U-POPSNCT05252533

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

A Phase 1 study testing Ustekinumab in people with Juvenile Psoriatic Arthritis and Psoriasis, run by Janssen Research & Development, LLC at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 5 to 17 years
What is being tested?
Ustekinumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
10 sitesUnited States
Study dates
24 May 2022to 26 Jan 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Akron Children s Hospital

    Akron, Ohio, 44308

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

  • Pediatric Rheumatology Consultants of Austin

    Austin, Texas, 78757

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital

    Chicago, Illinois, 60611-2991

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Newport Huntington Medical Group

    Huntington Beach, California, 92648

  • Childrens Hospital Los Angeles

    Los Angeles, California, 90027

  • Columbia University Medical Center

    New York, New York, 10032

  • Michigan Dermatology Institute

    Waterford, Michigan, 48328

Other trials in United States

About this study

Official title: Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants

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

Read the 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.

Being tested
Ustekinumab
Medical subject headings
Arthritis, Juvenile, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called STELARA

    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.

Study groups in NCT05252533
Study groupRoleWhat they receive
Cohort 1: Juvenile Psoriatic Arthritis (jPsA)ExperimentalParticipants (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).
Receives: Drug: Ustekinumab
Cohort 2: Pediatric Psoriasis (PsO)ExperimentalParticipants (aged >=6 to <18 years) will receive ustekinumab at the dose and frequency as prescribed by their treating HCP.
Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Concentration of Ustekinumab

    Serum samples will be analyzed to determine concentrations of ustekinumab using a validated, specific, and sensitive immunoassay method.

    Measured: Up to 16 weeks

Secondary outcomes (3)

  1. 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.

    Measured: Up to 20 weeks

  2. 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.

    Measured: Up to 20 weeks

  3. Number of Participants with Antibodies to Ustekinumab

    Number of participants with antibodies to ustekinumab will be reported.

    Measured: Up to 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start24 May 2022
  3. Primary completion26 Jan 2024
  4. Study completion26 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05252533
Sponsor's protocol ID
CR109159
Other IDs
CNTO1275ISD1001
Acronym
U-POPS
Status last verified
Apr 2025
First submitted
16 Feb 2022
Last updated
27 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Publications

  • 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.

    PubMed 41452420

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ustekinumab in people with Juvenile Psoriatic Arthritis and Psoriasis, run by Janssen Research & Development, LLC at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Concentration of Ustekinumab (time frame: Up to 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05252533, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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