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NCT02008916 · ClinicalTrials.gov registry record · Phase 3
16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 226
- Enrollment target
NCT02008916: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02008916 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 226 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02008916, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 226 participants
- Enrollment target
Study Summary
The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
Primary Outcome
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 was used to assess the efficacy of at least one dose of secukinumab versus placebo.
Interventions
- DRUG Secukinumab
- DRUG Placebo secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2014-01-14 |
| Est. Completion | 2017-12-11 |
| Phase | Phase 3 |
What the finished NCT02008916 record still lists
NCT02008916 is an interventional study that assigns participants to a tested intervention. The registered 226 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Secukinumab is the first listed.
NCT02008916 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02008916 about?
NCT02008916 is a clinical study titled "16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients". The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.
What is the current status of trial NCT02008916?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 226 participants. The study started on 2014-01-14. Estimated completion is 2017-12-11.
What interventions are being tested in trial NCT02008916?
The interventions under investigation include: Secukinumab (DRUG), Placebo secukinumab (DRUG).
Who is sponsoring clinical trial NCT02008916?
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 NCT02008916's enrollment target sits among peer trials
226 1310th of 2000 higher than 690 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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