A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults with Active Idiopathic Inflammatory Myopathy

JRCT ID: jRCT2031240524

Registered date:05/12/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Idiopathic inflammatory myopathy
• Date of first enrollment: 05/12/2024
• Target sample size: 22
• Countries of recruitment: United States,Japan,Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Cyprus,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Korea Republic of,Japan,Lithuania,Japan,Mexico,Japan,Netherland,Japan,Peru,Japan,Poland,Japan,Portugal,Japan,Servia,Japan,Sulovakia,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan
• Study type: Interventional

Intervention(s)

Biological: efgartigimod PH20 SC
Subcutaneous injection of efgartigimod coformulated with rHuPH20

Outcome(s)

Primary Outcome

- Incidence and severity of TEAEs, AESIs, and SAEs
- Changes and abnormalities in vital signs, ECG, and laboratory parameters

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Agna Neto, MD