clinical 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
argenx·phase3·enrolling by invitation·n = 240
MyositisActive Idiopathic Inflammatory MyopathyDermatomyositisPolymyositisImmune-Mediated Necrotizing MyopathyAntisynthetase SyndromeEfgartigimod PH20 SC
brief 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.
started
Sep 12, 2023
primary completion
Sep 1, 2028
completion
Sep 1, 2028
last updated
Jun 3, 2026
official title
A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol