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Clinical trial

A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 2 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasi

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Last updated:1st Jun 2012
Identifier: NCT01544595
This is 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) will be eligible to join this extension study. This extension study is 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 will be used.

 

Category Value
Date last updated at source 2016-04-11
Study type(s) Interventional
Expected enrolment 1150
Study start date 2012-06-01
Estimated primary completion date 2017-06-01

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