NCT02008916

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
DRUG	Secukinumab	AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
DRUG	Placebo secukinumab	Placebo to AIN457 (Secukinumab)

Timeline

• Start date: 2014-01-14
• Primary completion: 2015-02-23
• Completion: 2017-12-11
• First posted: 2013-12-11
• Last updated: 2019-01-08
• Results posted: 2018-12-12

Locations

57 sites across 10 countries: United States, Belgium, Czechia, Germany, Greece, Mexico, Portugal, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study