NCT03334058

A Study to Evaluate the Safety, PD, PK and Efficacy of ARGX-113 in Patients With Pemphigus

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is an open-label, non-controlled, adaptive-design Phase II study to evaluate the safety, pharmacodynamics, pharmacokinetics, efficacy, and conditions of use (dosage, frequency of administration at maintenance) of ARGX-113 in patients with mild to moderate Pemphigus (Vulgaris or Foliaceus), either newly diagnosed or relapsing. The total study duration for each patient is less than 6 months. It consists of a Screening period, an Induction, a maintenance treatment period followed by a treatment-free Follow-up (FU) period.

Conditions

• Pemphigus Vulgaris
• Pemphigus Foliaceus

Interventions

Type	Name	Description
DRUG	ARGX-113	human IgG1-derived Fc fragment that binds to human neonatal Fc receptor (FcRn)

Timeline

• Start date: 2017-10-18
• Primary completion: 2020-10-28
• Completion: 2020-10-28
• First posted: 2017-11-07
• Last updated: 2020-12-14

Locations

12 sites across 5 countries: Germany, Hungary, Israel, Italy, Ukraine