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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502851-79-00
Acronym
ARGX-113-2011
Enrollment
80
Registered
2023-09-05
Start date
2023-09-20
Completion date
Unknown
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Idiopathic Inflammatory Myopathy (IIM)

Brief summary

Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time, Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time

Detailed description

Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) over time, Prednisone dose reduction (average monthly dose) over time, Total improvement score (TIS) over time, Proportion of TIS responders (minimal, moderate, major) over time, Individual core set measure (CSMs) of the TIS over time, Percentage of participants with clinically inactive disease, defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter), Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks, during the study

Interventions

DRUGTACROLIMUS
DRUGMYCOPHENOLIC ACID
DRUGPREDNISOLONE
DRUGDEXAMETHASONE
DRUGHYDROCORTISONE
DRUGCICLOSPORIN
DRUGMETHOTREXATE
DRUGHYDROXYCHLOROQUINE SULFATE
DRUGMETHYLPREDNISOLONE
DRUGAZATHIOPRINE
DRUGMYCOPHENOLATE MOFETIL
DRUGLEFLUNOMIDE
DRUGBETAMETHASONE

Sponsors

Argenx
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Incidence and severity of treatment-emergent adverse events (TEAEs), adverse event(s) of special interests (AESIs,) and serious adverse events (SAEs) by System Organ Class (SOC) and Preferred Term (PT) over time, Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters over time

Secondary

MeasureTime frame
Composite Glucocorticoid Toxicity Index (C-GTI) comprising the Aggregate Improvement Score (AIS) and the Cumulative Worsening Score (CWS) over time, Prednisone dose reduction (average monthly dose) over time, Total improvement score (TIS) over time, Proportion of TIS responders (minimal, moderate, major) over time, Individual core set measure (CSMs) of the TIS over time, Percentage of participants with clinically inactive disease, defined as no evidence of disease activity, based on an Physician Global Assessment of Disease Activity (MDGA) and Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) of 0 and normal creatine kinase (CK) values for at least 12 weeks (at week 28 and every 24 weeks thereafter), Percentage of participants with remission, defined as a clinically inactive disease for at least 24 weeks, during the study

Countries

Austria, Belgium, Bulgaria, Cyprus, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026