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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 350 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02159053
The ClinicalTrials.gov registry entry for NCT02159053 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02159053 reports 0 study locations.
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.
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