16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
CompletedPhase 3NCT02159053
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Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Spondylitis, Ankylosing
- Interventions
- Biological: Secukinumab
- Biological: Secukinumab
- Biological: Placebo
- Sponsor
- Novartis Pharmaceuticals
- Organization
- Novartis
- Start date
- 2015-05-18
- Primary completion
- 2016-02-23
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Australia, Austria, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Greece, Italy, Netherlands, Norway, Poland, Russia, Slovakia, Spain, Switzerland, United Kingdom, United States
- Total sites listed
- 90
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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. Other protocol-defined inclusion/exclusion criteria do apply.
Canadian sites (3)
| Facility | City | Province |
|---|---|---|
| Novartis Investigative Site | Winnipeg | Manitoba |
| Novartis Investigative Site | Pointe-Claire | Quebec |
| Novartis Investigative Site | Trois-Rivières | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02159053