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

February 28, 2024 updated by: Janssen Research & Development, LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Huntington Beach, California, United States, 92648
        • Newport Huntington Medical Group
      • Los Angeles, California, United States, 90027
        • Childrens Hospital Los Angeles
    • Illinois
      • Chicago, Illinois, United States, 60611-2991
        • Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
    • Michigan
      • Waterford, Michigan, United States, 48328
        • Michigan Dermatology Institute
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Children s Hospital
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center of Central Texas
      • Austin, Texas, United States, 78757
        • Pediatric Rheumatology Consultants of Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.
Other Names:
  • STELARA
Experimental: 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.
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.
Other Names:
  • STELARA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Concentration of Ustekinumab
Time Frame: Up to 16 weeks
Serum samples will be analyzed to determine concentrations of ustekinumab using a validated, specific, and sensitive immunoassay method.
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to 20 weeks
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)
Time Frame: Up to 20 weeks
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
Time Frame: Up to 16 weeks
Number of participants with antibodies to ustekinumab will be reported.
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Actual)

January 26, 2024

Study Completion (Actual)

January 26, 2024

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR109159
  • CNTO1275ISD1001 (Other Identifier: Janssen Research and development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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