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Enrolling by invitationPhase 3

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

Who runs it
argenx
Where
Lisbon and Porto, PortugalSee the 2 sitesAlso in 30 other countries, 117 sites
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

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

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 Portugal

Also in 30 other countries, 117 sites

  • Centro Hospitalar Universitario De Lisboa Norte E.P.E.Lisbon, PortugalNo longer taking part
  • Centro Hospitalar Universitário de Santo Antonio,E.P.E.Porto, PortugalNo 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
Record updated
16 October 2026