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A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

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Trial Profile

A Phase 3, Multicenter, randomized, double-blind study evaluating the efficacy and safety of ABP 501 compared with Adalimumab in subjects with moderate to severe plaque psoriasis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2023

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Plaque psoriasis
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen

    • Most Recent Events

    • 04 May 2021 According to an Amgen media release, AMGEVITA was approved in Canada based on a robust data package supporting biosimilarity to the reference product, Humira, based on analytical, nonclinical, pharmacokinetic and clinical data, including results from two confirmatory clinical studies conducted in moderate-to-severe psoriasis (PsO) and moderate-to-severe rheumatoid arthritis (RA) patients.
    • 24 Oct 2018 Results assessing incidence and magnitude of anti-drug antibodies response among patients that transitioned from adalimumab RP to ABP 501 presented at the 26th United European Gastroenterology Week
    • 24 Oct 2018 Results assessing incidence and magnitude of binding and neutralizing anti-drug antibodies in the trial presented at the 26th United European Gastroenterology Week

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