NCT02159053

16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis

A Randomized, Double-blind, Placebo-controlled, Phase III Multicenter Study of Subcutaneous Secukinumab (150 mg) With and Without a Subcutaneous Loading Regimen to Assess Efficacy, Safety, and Tolerability up to 2 Years in Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
BIOLOGICAL	Secukinumab	Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
BIOLOGICAL	Secukinumab	Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
BIOLOGICAL	Placebo	Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio

Timeline

• Start date: 2015-05-18
• Primary completion: 2016-02-23
• Completion: 2018-01-02
• First posted: 2014-06-09
• Last updated: 2019-04-10
• Results posted: 2019-04-10

Locations

90 sites across 19 countries: United States, Australia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Greece, Italy, Netherlands, Norway, Poland, Russia, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study