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

Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants - U-POPS (Ustekinumab Pediatric Opportunistic PK Study)

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-005085-18-Outside-EU/EEA
Enrollment
Unknown
Registered
2024-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric psoriasis(PsO) Juvenile psoriatic arthritis (jPsA) MedDRA version: 20.0 Level: PT Classification code 10076674 Term: Juvenile psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: STELARA® Product Name: Ustekinumab Product Code: CNTO1275 Pharmaceutical Form: Solution for injection INN or Proposed INN: Ustekinumab CAS Number: 815610-63-0 Current Sponsor code: CNTO127

Sponsors

Janssen Research & Development, LLC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age and Disease Characteristics 1. =5 to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

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

Countries

United States

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026