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Enrolling by invitationPhase 3

Long-term safety of efgartigimod injections in adults with active idiopathic inflammatory myopathy

Tests efgartigimod given under the skin in adults with active inflammatory muscle disease.

Key facts

Who runs it
argenx
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 sitesAlso in 30 other countries, 101 sites
Registry title
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Status
Enrolling by invitation
Phase
Phase 3
People taking part
240 people, planned
Started
12 Sept 2023
Expected to end
Sept 2028
Type of study
Interventional
Treatments tested
  • Efgartigimod PH20 SC
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with active idiopathic inflammatory myopathy (myositis, a muscle inflammation disease) who completed study ARGX-113-2007. They will get efgartigimod PH20 SC, an injection under the skin, for up to 51 months.

Age
18 years and older
Sex
All sexes can join
Disease stage
Active idiopathic inflammatory myopathy, including dermatomyositis, polymyositis, immune-mediated necrotizing myopathy and antisynthetase syndrome
Earlier treatment
Must have completed trial ARGX-113-2007.

Main reasons for not taking part

  • Planning major surgery during the study
  • A new health problem since joining ARGX-113-2007 that the study doctor thinks makes joining unsafe or would affect the results
  • Known allergic reaction to the study drug or its ingredients
  • Any new or returning cancer, except basal cell skin cancer

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in United States

Also in 30 other countries, 101 sites

  • 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

About the trial

What the trial wants to find out

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

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.

The group in the trial

  • Efgartigimod PH20 SCTreatment being tested

    Participants receiving efgartigimod PH20 subcutaneously

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Long-term safety of efgartigimod injections in adults with active idiopathic inflammatory myopathyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
16 October 2026