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An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients With Mild to Moderate Pemphigus (Vulgaris and Foliaceus)

Trial Profile

An Open-label, Non-controlled, Phase II Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, Efficacy and Conditions of Use of ARGX-113 in Patients With Mild to Moderate Pemphigus (Vulgaris and Foliaceus)

Recruiting
Phase of Trial: Phase II

Latest Information Update: 16 Aug 2018

At a glance

  • Drugs Efgartigimod (Primary)
  • Indications Pemphigus; Pemphigus vulgaris
  • Focus Adverse reactions; Proof of concept
  • Sponsors argenx
  • Most Recent Events

    • 24 Jul 2018 According to an argenx media release, full data is expected in the first half of 2019.
    • 20 Jun 2018 Results presented in the argenx media release.
    • 20 Jun 2018 Independent Data Monitoring Committee (IDMC) determined the tolerability profile of efgartigimod to be favorable and recommended advancing to cohort 2, with maintaining the dose at 10 mg/kg, but adjusted the dosing frequency and duration of the maintenance phase. The second cohort will dose every two weeks during the maintenance phase and will add two additional administrations for a period of eight total weeks of maintenance, up from six weeks in cohort 1, according to an argenx media release.
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