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A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS

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Trial Profile

A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2024

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At a glance

  • Drugs Bimekizumab (Primary)
  • Indications Ankylosing spondylitis
  • Focus Registrational; Therapeutic Use
  • Acronyms BE MOBILE 2
  • Sponsors UCB Biopharma

    • Most Recent Events

    • 14 Mar 2024 According to an UCB media release, company announced that that BIMZELX (bimekizumab injection) has received authorization from Health Canada for two new indications active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA). The approval was is supported by Phase III clinical trial data BE OPTIMAL, BE COMPLETE, BE MOBILE 1 & BE MOBILE 2.
    • 27 Dec 2023 According to an UCB media release, based on results from MOBILE 1 and BE MOBILE 2 studies, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved BIMZELX (bimekizumab) for the treatment of adults with non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS) who are not sufficiently responding to existing treatments.
    • 15 Nov 2023 Results of pooled analysis from BE MOBILE 1 and BE MOBILE 2, assessing maintenance of stringent clinical responses through 1 year of treatment with BKZ in pts with non radiographic axSpA (nr axSpA) and radiographic axSpA , presented at the ACR Convergence 2023
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