drugset
drugset / Trial / NCT04156620

Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA

NCT04156620 ↗

Phase 3 Completed 527 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-12-11
Primary completion
2022-02-17
Completion
2022-12-20

Outcome

Met primary endpoint

registry AIN457 6 mg/kg - 3 mg/kg i.v. vs Placebo - AIN457 3 mg/kg i.v.; p <0.0001; Marginal difference 17.91 (95% CI 10.12 to 25.71) NCT04156620 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Secukinumab Monoclonal antibody 3 mg/kg Intravenous

Indications

ankylosing spondylitis