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

NCT05252533 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR109159CNTO1275ISD1001
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Juvenile Psoriatic Arthritis; Psoriasis; Arthritis, Juvenile

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Number of Participants with Adverse Events (AEs)

  Up to 20 weeks

• Number of Participants with Serious Adverse Events (SAEs)

  Up to 20 weeks

• Number of Participants with Antibodies to Ustekinumab

  Up to 16 weeks

Study Arms (2)

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).

Drug: Ustekinumab

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.

Drug: Ustekinumab

Interventions

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.

Also known as: STELARA

Cohort 1: Juvenile Psoriatic Arthritis (jPsA); Cohort 2: Pediatric Psoriasis (PsO)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (10)

Newport Huntington Medical Group

Huntington Beach, California, 92648, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

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

Chicago, Illinois, 60611-2991, United States

Location

Michigan Dermatology Institute

Waterford, Michigan, 48328, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Akron Children s Hospital

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

Location

Pediatric Rheumatology Consultants of Austin

Austin, Texas, 78757, United States

Location

Related Publications (1)

• 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.

  PMID: 41452420 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile; Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 23, 2022
• Study Start: May 24, 2022
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (10)