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NCT02159053 · ClinicalTrials.gov registry record · Phase 3
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 350
- Enrollment target
NCT02159053: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02159053 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 350 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02159053, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 350 participants
- Enrollment target
Study 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.
Primary Outcome
ASAS 20 response is a validated composite assessment, defined as an improvement of at least 20 percent (%) and 1 unit on a scale of 10 in three main domains and no worsening of at least 20% and 1 unit on a scale of 10 in the fourth domain within a defined time frame. Four main ASAS domains include: 1. Patient's global assessment of disease activity measured on a 100 mm VAS ranging from not severe to very severe 2. Patient's assessment of back pain, measured on a 100 mm VAS ranging from no pain t
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2018-01-02 |
| Phase | Phase 3 |
What the finished NCT02159053 record still lists
NCT02159053 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02159053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02159053 about?
NCT02159053 is a clinical study titled "16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants 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, sa...
What is the current status of trial NCT02159053?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2015-05-18. Estimated completion is 2018-01-02.
What interventions are being tested in trial NCT02159053?
The interventions under investigation include: Placebo (BIOLOGICAL), Secukinumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02159053?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02159053's enrollment target sits among peer trials
350 1034th of 2000 higher than 956 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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