A study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with active idiopathic inflammatory myopathy.
- Conditions
- Active Idiopathic Inflammatory Myopathy (IIM)MedDRA version: 20.0Level: SOCClassification code: 10028395Term: Musculoskeletal and connective tissue disorders Class: 17Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- CTIS2022-502851-79-00
- Lead Sponsor
- Argenx
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 240
Has completed ARGX-113-2007, Is capable of providing signed informed consent and complying with protocol requirements, Agrees to use contraceptive measures consistent with local regulations and the following: • women of childbearing potential (WOCBP) must have a negative urine pregnancy test at baseline before receiving investigational medicinal product (IMP).
Intention to have major surgery during the ARGX-113-2011 study period; or any other medical condition that has arisen since enrollment in 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 to investigational medicinal product (IMP) 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 investigational medicinal product (IMP) in ARGX-113-2007, or met the permanent discontinuation criteria at the rollover visit., Diagnosis with a deselected subtype of IIM based on the analysis of the phase 2 stage data in ARGX-113-2007, unless the investigator determines that the participant is benefiting from investigational medicinal product (IMP) as defined by a score of much better” or moderately better” on the Clinical Global Impression of Change (CGI-C) and Patient Global Impression of Change (PGI-C) assessments for at least 12 weeks, and that enrolling in the study is in the participant’s best interest
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with IIM;Secondary Objective: To assess the health impact of glucocorticoid use and evaluate the steroid-sparing effect of efgartigimod PH20 SC, To observe the long-term efficacy of efgartigimod PH20 SC;Primary end point(s): 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 Outcome Measures
Name Time Method