16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

Status:	Completed
Conditions:	Neurology, Neurology
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	18 - Any
Updated:	1/10/2019
Start Date:	January 14, 2014
End Date:	December 11, 2017

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year
efficacy, safety and tolerability data in subjects with active AS despite current or previous
NSAID, DMARD and/or anti-TNF therapy.

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria:
pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI,
previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any
biological immunomodulating agent excluding TNF antagonists, previous cell depleting
therapy.

We found this trial at

sites

Novartis Investigational Site

Austin, Texas 78759

from

Austin, TX