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A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa

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Trial Profile

A Phase 3 Multicenter, Open-label, Single Arm Study of the Safety and Efficacy of Adalimumab in Japanese Subjects With Moderate to Severe Hidradenitis Suppurativa

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2021

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At a glance

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

    • 29 May 2020 According to an AbbVie media release, the approval of partial changes in the marketing approval of HUMIRA (adalimumab) for additional dosage and administration, was supported by the results of efficacy and safety evaluations at 80mg Q2W for HUMIRA in this Japanese phase III study (Study M15-573) and the results obtained by simulation with data in clinical pharmacokinetic studies.
    • 29 May 2020 According to an AbbVie media release, previously, the recommended dose of HUMIRA for HS patients was 160 mg in week 0, followed by 80 mg two weeks later, administered by subcutaneous injection. Starting at week 4, HUMIRA should be administered at a dose of 40mg once weekly (QW). Today, an 80mg Q2W regimen has been newly added as a treatment option with efficacy and safety equivalence to those of the 40mg QW regimen.
    • 29 May 2020 According to an AbbVie media release, AbbVie GK and Eisai Co., Ltd. today announced an approval of partial changes in the marketing approval of HUMIRA (adalimumab) for additional dosage and administration, specifically, to add an 80mg every-other-week (Q2W) regimen as a treatment option for patients with hidradenitis suppurativa (HS) after the first 4 weeks of treatment.
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