Clinical Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants

Phase 1

• Conditions: Pediatric psoriasis(PsO)Juvenile psoriatic arthritis (jPsA); MedDRA version: 20.0Level: PTClassification code 10076674Term: Juvenile psoriatic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2021-005085-18-Outside-EU/EEA
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-06
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age and Disease Characteristics
1. =5 to <18 years of age, inclusive, with a diagnosis of jPsA (ie, ILAR or Vancouver criteria) by qualified HCP.
AND / OR
=6 to <18 years of age, inclusive, with a diagnosis of pediatric PsO by a qualified HCP.
Type of Participant
2. Initiated ustekinumab treatment =16 weeks prior to enrollment and received 3 or more doses of ustekinumab prior to enrollment.
Informed Consent
3. 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any potential participant who meets any of the following criteria will be excluded from
participating in the study.
1. Has poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
2. Has any condition that, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
3. If currently enrolled in an investigational study, contact the Study Responsible Physician to discuss eligibility for inclusion in study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis(PsO);Secondary Objective: Evaluate the safety of ustekinumab;Primary end point(s): Observed serum ustekinumab concentrations.;Timepoint(s) of evaluation of this end point: Cumulative samples from visits 1-4

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The occurrences and type of adverse events (AEs) and all serious adverse events (SAEs).<br>;Timepoint(s) of evaluation of this end point: From signing of ICF through 3 days after completion of the<br>participant's last study-related procedure.