drugset / Trial / NCT01544595

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

NCT01544595

Phase 3 Completed 1147 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

Timeline

Start
2012-06-19
Primary completion
2017-06-26
Completion
2017-06-26

Drugs

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

Indications