drugset / Trial / NCT05979441

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy

NCT05979441

Phase 3 Enrolling by invitation 240 enrolled argenx
NaSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in ARGX-113-2007. The study consists of a treatment period where participants will receive efgartigimod PH20 SC for up to 51 months. The treatment period will be followed by a treatment-free safety follow-up period of 56 days.

Timeline

Start
2023-09-12
Primary completion
2028-09
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic Subcutaneous