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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active Reference (Adalimumab) Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2025

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At a glance

  • Drugs Bimekizumab (Primary) ; Adalimumab
  • Indications Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms BE OPTIMAL
  • Sponsors UCB Biopharma

    • Most Recent Events

    • 23 Sep 2024 According to an UCB media release, company announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA). The approval of bimekizumab-bkzx for adult patients with active PsA is supported by data from the Phase 3 BE OPTIMAL and BE COMPLETE studies.
    • 12 Jun 2024 According to an UCB media release, company announced that the data of this trial is presented at the European Congress of Rheumatology, EULAR 2024, in Vienna, Austria, June 12 to 15.
    • 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.

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