WHO ICTRP trial

A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to…

EUCTR2017-002333-40-HU · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-002333-40-HU
Public title A study to evaluate the safety and efficacy of ARGX-113 in patients with Mild to Moderate Pemphigus (Vulgaris or Foliaceus)
Scientific title 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 or Foliaceus)
Primary sponsor argenx BVBA
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Hungary;Ukraine;Romania;Israel;Germany;Italy
Conditions Pemphigus (Vulgaris or Foliaceus) MedDRA version: 20.0 Level: LLT Classification code 10052802 Term: Pemphigus vulgaris System Organ Class: 100000004858 MedDRA version: 20.0 Level: LLT Classification code 10057069 Term: Pemphigus foliaceus…
Interventions Product Name: ARGX-113 Product Code: ARGX-113 Pharmaceutical Form: Solution for infusion INN or Proposed INN: efgartigimod CAS Number: 1821402-21-4 Current Sponsor code: ARGX-113 Concentration unit: mg/kg milligram(s)/kilogram Concentration…
Registration date Jul 20, 2017
Target size 12
Secondary IDs ARGX-113-1701;2017-002333-40-DE
Registry page clinicaltrialsregister.eu

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