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
Phase 3
- Conditions
- M60 NULL
- Registration Number
- PER-032-23
- Lead Sponsor
- Argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- In enrollment
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
Participants can be included in the study only if all of the following criteria apply:
1. Has completed ARGX-113-2007
2. Is capable of providing signed informed consent, as described in Section 10.1.3, and
complying with protocol requirements
3. Agrees to use contraceptive measures consistent with local regulations and the following:
• WOCBP (defined in Section 10.4.1) must have a negative urine pregnancy test at baseline before receiving IMP (Section 10.4.2.1).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method