A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants (≥6 To <18 Years of Age)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503378-19-00

Enrollment

Registered

2024-01-17

Start date

2018-08-23

Completion date

Unknown

Last updated

2026-01-15

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

Conditions

Chronic Plaque Psoriasis

Brief summary

The proportion of participants with a PASI 75 response at Week 16.

Interventions

DRUGEnbrel 50 mg solution for injection in pre-filled syringe

DRUGGuselkumab - solution for injection in pre-filled syringe - 100 mg/mL

DRUGGuselkumab 1 mL PFS Placebo

DRUGGuselkumab

DRUGGuselkumab 0.5 mL Varioject Placebo

DRUGEnbrel 25 mg powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The proportion of participants with a PASI 75 response at Week 16.	—

Countries

Belgium, Germany, Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026