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
- Bari, Milan, Pisa, Rome, Rozzano, and Udine, ItalySee the 7 sites
- Phase
- Phase 3
Where in Italy
- Azienda Universitaria Ospedaliera Consorziale Policlinico BariBari, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyNo longer taking part
- Humanitas Research HospitalRozzano, ItalyNo longer taking part
- Azienda Sanitaria Universitaria Friuli CentraleUdine, ItalyNo 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.