drugset / Trial / NCT02008890

Palmoplantar Pustular Psoriasis Efficacy and Safety With Secukinumab

NCT02008890 ↗

Phase 3 Completed 237 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

Timeline

Start
2013-12-26
Primary completion
2014-11-24
Completion
2017-05-31

Outcome

Met primary endpoint

registry NUMBER AIN457 300mg: 26.6 percentage of participants NCT02008890 ↗

registry analysis (superiority test); AIN457 300mg vs Placebo; p = 0.0411; Odds Ratio (OR) 2.62 (95% CI 1.04 to 6.60); Regression, Logistic NCT02008890 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 150 mg Subcutaneous
Subject Secukinumab Monoclonal antibody 300 mg Subcutaneous