Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
Public ClinicalTrials.gov record NCT04156620. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Ankylosing Spondylitis or Non-radiographic Axial SpondyloArthritis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04156620
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 527 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 11, 2019 (Actual)
- Primary completion
- Feb 17, 2022 (Actual)
- Completion
- Dec 20, 2022 (Actual)
- Last update posted
- Jun 18, 2024
2019 – 2022
United States locations
- U.S. sites
- 25
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Irvine | California | 92604 | — |
| Novartis Investigative Site | La Mesa | California | 91942 | — |
| Novartis Investigative Site | San Leandro | California | 94578 | — |
| Novartis Investigative Site | Upland | California | 91786 | — |
| Novartis Investigative Site | Ocoee | Florida | 34761 | — |
| Novartis Investigative Site | Plantation | Florida | 33324 | — |
| Novartis Investigative Site | Winter Park | Florida | 32789 | — |
| Novartis Investigative Site | Bowling Green | Kentucky | 42101 | — |
| Novartis Investigative Site | Cumberland | Maryland | 21740 | — |
| Novartis Investigative Site | Grand Blanc | Michigan | 48439 | — |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | — |
| Novartis Investigative Site | Potsdam | New York | 13676 | — |
| Novartis Investigative Site | Greensboro | North Carolina | 27408 | — |
| Novartis Investigative Site | Middleburg Heights | Ohio | 44130 | — |
| Novartis Investigative Site | Portland | Oregon | 97239 | — |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | — |
| Novartis Investigative Site | Columbia | South Carolina | 29204 | — |
| Novartis Investigative Site | Jackson | Tennessee | 38305 | — |
| Novartis Investigative Site | Memphis | Tennessee | 38119 | — |
| Novartis Investigative Site | Katy | Texas | 77494 | — |
| Novartis Investigative Site | Spring | Texas | 77382 | — |
| Novartis Investigative Site | The Woodlands | Texas | 77380 | — |
| Novartis Investigative Site | Everett | Washington | 98208 | — |
| Novartis Investigative Site | Spokane | Washington | 99204 | — |
| Novartis Investigative Site | Beckley | West Virginia | 25801 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04156620, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 18, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04156620 live on ClinicalTrials.gov.