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)
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History