drugset / Trial / NCT01640951

4 Year Extension Study of Efficacy and Safety of Secukinumab in Patients With Moderate to Severe Chronic Plaque-type Psoriasis

NCT01640951

Phase 3 Completed 675 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupDouble-blindTreatment

Summary

CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

Timeline

Start
2012-09-16
Primary completion
2017-05-04
Completion
2017-05-04

Drugs

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

Indications