NCT05979441
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Enrolling by Invitation
PHASE3Ages 18+InterventionalTreatmentargenx
~240 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Efgartigimod PH20 SC
At a glance
Recruiting sites
0 of 92 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of AEs, SAEs and AESIs over time
Measured over Up to 53 months
Conditions
Where it's being run
92 sites across 42 statesChina7
Italy7
Germany6
Japan6
Georgia5
Thailand5
California3
Florida3
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
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
What this trial measures
- Incidence of AEs, SAEs and AESIs over timeUp to 53 months
AE : adverse event ; SAE : serious adverse event ; AESI : adverse event of special interest.