A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults with Active Idiopathic Inflammatory Myopathy
Recruiting
- Conditions
- Idiopathic inflammatory myopathy
- Registration Number
- jRCT2031240524
- Lead Sponsor
- argenx BV (ICCC: ICON Clinical Research GK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- 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 investigational medicinal product
Exclusion Criteria
- 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 investigational medicinal product or 1 of its excipients
- Development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness
- Permanent discontinuation of IMP in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit
- Diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in ARGX-113-2007. However, the investigator determines that administering the investigational medicinal product to participant would be beneficial for the participant(criteria: if the participant is evaluated as "much better" or "moderately better" for at least 12 weeks on the CGI-C and PGI-C assessments
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Incidence and severity of TEAEs, AESIs, and SAEs Incidence and severity of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Changes and abnormalities in vital signs, ECG, and laboratory parameters Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters
- Secondary Outcome Measures
Name Time Method