drugset / Trial / NCT02471144

Pediatric Study in Children and Adolescents With Severe Plaque Psoriasis

NCT02471144

Phase 3 Completed 162 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This was a multicenter, randomized, double-blind, placebo- and active-controlled (etanercept in single blinded arm) study in pediatric subjects aged 6 years to less than 18 years with severe chronic plaque psoriasis. Approximately 160 subjects aged 6 years to \<18 years were enrolled, of which at least 30 were 6 years to \<12 years old. Subjects were enrolled at approximately 70 study sites worldwide.

Timeline

Start
2015-09-29
Primary completion
2018-12-13
Completion
2023-03-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etanercept Protein / enzyme biologic 0.8 mg/kg Subcutaneous
Subject Secukinumab Monoclonal antibody 75 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous

Indications