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NCT02696031 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 555
- Enrollment target
NCT02696031: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02696031 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 555 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02696031, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 555 participants
- Enrollment target
Study Summary
The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208
Primary Outcome
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondyl
Interventions
- DRUG Placebo
- DRUG Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 555 participants |
| Start Date | 2016-04-29 |
| Est. Completion | 2021-03-11 |
| Phase | Phase 3 |
What the finished NCT02696031 record still lists
NCT02696031 is an interventional study that assigns participants to a tested intervention. The registered 555 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 (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02696031 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02696031 about?
NCT02696031 is a clinical study titled "Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis". The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a...
What is the current status of trial NCT02696031?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 555 participants. The study started on 2016-04-29. Estimated completion is 2021-03-11.
What interventions are being tested in trial NCT02696031?
The interventions under investigation include: Placebo (DRUG), Secukinumab (DRUG).
Who is sponsoring clinical trial NCT02696031?
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 NCT02696031's enrollment target sits among peer trials
555 676th of 2000 higher than 1,323 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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