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A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II

Trial Profile

A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa - PIONEER II

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2019

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At a glance

  • Drugs Adalimumab (Primary)
  • Indications Hidradenitis suppurativa
  • Focus Registrational; Therapeutic Use
  • Acronyms PIONEER II
  • Sponsors AbbVie
  • Most Recent Events

    • 27 Mar 2019 Results evaluating the optimal medium-term adalimumab maintenance dosing strategy in moderate-to-severe HS using PIONEER I and PIONEER II trials published in the British Journal of Dermatology
    • 21 Feb 2019 According to a media release published by Eisai Co Ltd and AbbVie, the companies have received approval in Japan for an additional indication of HUMIRA (Adalimumab) for the treatment of hidradenitis suppurativa (HS). The approval of this additional indication is based on the data from a Japanese Phase III study and overseas clinical trials (PIONEER I and PIONEER II).
    • 05 Jun 2018 According to the AbbVie media release, company submitted an application in Japan, for the approval of adalimumab for the supplementation of suppurative sweatitis (hidradenitis suppurativa), based on the data from this and PIONEER I trial.
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