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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2024

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At a glance

  • Drugs Secukinumab (Primary)
  • Indications Ankylosing spondylitis; Non-radiographic axial spondyloarthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms INVIGORATE-1
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 01 Jan 2024 Primary endpoint has been met. (The proportion of subjects achieving an ASAS40 (Assessment of SpondyloArthritis International Society criteria) response.), according to the results presented at the ACR Convergence 2023.
  • 15 Nov 2023 Results assessing safety and efficacy of IV SEC in patients with active axSpA, presented at the ACR Convergence 2023.
  • 08 Feb 2023 Status changed from active, no longer recruiting to completed.

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