16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | May 18, 2015 |
| End Date: | January 2, 2018 |
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
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.
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.
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.
We found this trial at
16
sites
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