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

NCT03334058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-12-14

No results posted yet for this study

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

DRUG

ARGX-113

human IgG1-derived Fc fragment that binds to human neonatal Fc receptor (FcRn)

Sponsors & Collaborators

Principal Investigators

  • Patrick Dupuy, MD · argenx

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-18
Primary Completion
2020-10-28
Completion
2020-10-28

Countries

  • Germany
  • Hungary
  • Israel
  • Italy
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03334058 on ClinicalTrials.gov