A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Key facts
- Where
- Atlanta, Austin, Baltimore, Beverly Hills, Chapel Hill, Chicago, Columbus, Gainesville, Great Neck, Houston, Jacksonville, New Haven, Orange, Phoenix, Pittsburgh, Portland, San Francisco, and Tampa, United StatesSee the 18 sites
- Phase
- Phase 3
Where in United States
- Emory Healthcare - Emory Clinic - RheumatologyAtlanta, United StatesNo longer taking part
- Austin Neuromuscular Center; National Neuromuscular Research Institute, PLLCAustin, United StatesNo longer taking part
- John Hopkins Medicine - Johns Hopkins Myositis CenterBaltimore, United StatesNo longer taking part
- Attune Health Research IncBeverly Hills, United StatesNo longer taking part
- University of North Carolina (UNC) School of MedicineChapel Hill, United StatesNo longer taking part
- Northwestern Medicine - Northwestern Memorial HospitalChicago, United StatesNo longer taking part
- The Ohio State UniversityColumbus, United StatesNo longer taking part
- UF Health - Rheumatology Medical Specialties Medical PlazaGainesville, United StatesNo longer taking part
- Northwell Health Physician Partners RheumatologyGreat Neck, United StatesNo longer taking part
- Nerve and Muscle Center of TexasHouston, United StatesNo longer taking part
- Mayo Clinic - Florida - NeurologyJacksonville, United StatesNo longer taking part
- Yale Cancer Center-Yale University School Of MedicineNew Haven, United StatesNo longer taking part
- UCI Health - ALS and Neuromuscular Center - NeurologyOrange, United StatesNo longer taking part
- Neuromuscular Clinical and Research Center - NeurologyPhoenix, United StatesNo longer taking part
- University of Pittsburgh Medical CenterPittsburgh, United StatesNo longer taking part
- Oregon Health and Science UniversityPortland, United StatesNo longer taking part
- UCSF Health - ALS and Neurodegenerative Disease Center - DermatologySan Francisco, United StatesNo longer taking part
- University of South Florida (USF) - Morsani Center (USF Health Carol and Frank Morsani Center for Advanced Healthcare)Tampa, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- argenx
- Trial code
- NCT05979441EU 2022-502851-79-00
- Record updated
- 16 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Has completed trial ARGX-113-2007; Being capable of providing signed informed consent and complying with protocol requirements; Agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the study drug.
Exclusion: Intention to have major surgery during the study period or any other medical condition that has arisen since enrollment in study ARGX-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk; Known hypersensitivity reaction to the study drug or 1 of its excipients; Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness.