NCT03218488

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

An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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

• Psoriasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-10-25
• Primary completion: 2032-08-31
• Completion: 2032-08-31
• First posted: 2017-07-14
• Last updated: 2026-04-13

Locations

30 sites across 11 countries: Austria, Belgium, Denmark, France, Germany, Greece, Netherlands, Norway, Russia, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study