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NCT04156620 · ClinicalTrials.gov registry record · Phase 3
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 527
- Enrollment target
NCT04156620: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04156620 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 527 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04156620, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 527 participants
- Enrollment target
Study Summary
The purpose of this global study was to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in participants with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA ) at Week 16 despite current or previous non-steroidal anti inflammatory drugs (NSAID), disease-modifying antirheumatic drugs (DMARD) and/or anti Tumor Necrosis Factor (TNF) therapy. In addition, to further support efficacy and safety of an i.v. regimen, data was collected for up to 52 weeks of treatment.
Primary Outcome
ASAS40 is ≥ 40% and an absolute improvement from baseline of ≥20 units (range 0-100) in ≥ 3 of the following 4 domains: back pain \[10 cm visual analogue scale (VAS)\], patient global assessment of disease activity (10 cm VAS), physical function (BASFI; range 0-100) and inflammation (mean score of items 5 and 6 of the BASDAI; both 10 cm VAS) without any worsening in the remaining domain. ASAS consists of 6 domains (4 main and 2 additional): 1. Patient's global assessment measured on a visual an
Interventions
- DRUG Placebo
- DRUG Secukinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2019-12-11 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 3 |
What the finished NCT04156620 record still lists
NCT04156620 is an interventional study that assigns participants to a tested intervention. The registered 527 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 (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04156620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04156620 about?
NCT04156620 is a clinical study titled "Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA". The purpose of this global study was to demonstrate the efficacy, safety, and tolerability of an intravenous (i.v.) regimen of secukinumab compared to placebo in participants with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA ) at Week 16 despite current or...
What is the current status of trial NCT04156620?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 527 participants. The study started on 2019-12-11. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT04156620?
The interventions under investigation include: Placebo (DRUG), Secukinumab (DRUG).
Who is sponsoring clinical trial NCT04156620?
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 NCT04156620's enrollment target sits among peer trials
527 715th of 2000 higher than 1,286 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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