MedTrace Logo

A Safety Study of Ustekinumab in the Treatment of Pediatric Participants Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

NCT03218488 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).

Conditions

Interventions

DRUG

Ustekinumab

Participants will not receive any intervention as part of this study. Participants with moderate to severe plaque psoriasis who are initiating treatment with ustekinumab in clinical practice (patients should either start therapy with ustekinumab within 2 months after the first assessment in the study or have started therapy with ustekinumab in the 12-week period before the first assessment in the study for the treatment of psoriasis) will be observed for the long-term safety of ustekinumab and the long-term effects of ustekinumab on growth and development.

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2032-08-31
Completion
2032-08-31
FDA Drug
Yes

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Netherlands
  • Norway
  • Russia
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03218488 on ClinicalTrials.gov