16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
Completed · Phase 3 · Has a placebo group
Conditions studied: Spondylitis, Ankylosing
In brief
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.
Key facts
- Study ID
- NCT02159053
- Run by
- Novartis Pharmaceuticals
- People needed
- 350
- Starts
- 2015-05-18
- Expected to finish
- 2018-01-02
- Last updated by the study team
- 2019-04-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Novartis Investigative Site — Upland, California, United States
- Novartis Investigative Site — Aventura, Florida, United States
- Novartis Investigative Site — Peoria, Illinois, United States
- Novartis Investigative Site — Shreveport, Louisiana, United States
- Novartis Investigative Site — Lincoln, Nebraska, United States
- Novartis Investigative Site — Voorhees Township, New Jersey, United States
- Novartis Investigative Site — Oklahoma City, Oklahoma, United States
- Novartis Investigative Site — Duncansville, Pennsylvania, United States
- Novartis Investigative Site — Columbia, South Carolina, United States
- Novartis Investigative Site — Mesquite, Texas, United States
- Novartis Investigative Site — Seattle, Washington, United States
- Novartis Investigative Site — Kogarah, New South Wales, Australia
- Novartis Investigative Site — Maroochydore, Queensland, Australia
- Novartis Investigative Site — Hobart, Tasmania, Australia
- Novartis Investigative Site — Malvern East, Victoria, Australia
- Novartis Investigative Site — Graz, Austria
- Novartis Investigative Site — Vienna, Austria
- Novartis Investigative Site — Vienna, Austria
- Novartis Investigative Site — Pleven, Bulgaria
- Novartis Investigative Site — Plovdiv, Bulgaria
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Sofia, Bulgaria
- Novartis Investigative Site — Targovishte, Bulgaria
- Novartis Investigative Site — Winnipeg, Manitoba, Canada
- Novartis Investigative Site — Anniston, Alabama, United States
Full record on ClinicalTrials.gov
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