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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Axial Spondyloarthritis

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Trial Profile

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of KHK4827 in Subjects With Axial Spondyloarthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2022

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At a glance

  • Drugs Brodalumab (Primary)
  • Indications Ankylosing spondylitis; Axial spondyloarthritis; Non-radiographic axial spondyloarthritis
  • Focus Therapeutic Use
  • Sponsors Kyowa Kirin
  • Most Recent Events

    • 12 Sep 2022 Results assessing long-term efficacy and safety of brodalumab in patients with axial spondyloarthritis, published in the Rheumatology.
    • 07 Apr 2021 Results reporting the interim analysis efficacy and safety results of brodalumab vs placebo from the 16-week double-blind randomised period. published in the Annals of the Rheumatic Diseases
    • 27 Nov 2020 According to a Kyowa Kirin media release, LUMICEF was granted the supplemental approval for the treatment of ankylosing spondylitis (AS) 1 and non-radiographic axial spondyloarthritis (nr-axSpA) 2 in Japan.
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