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- (ARGX-113-2011) 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
Clinical Trial
(ARGX-113-2011) 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
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with idiopathic inflammatory myopathy (IIM) who previously participated in ARGX-113-2007. Participants will receive fixed weekly injections of efgartigimod PH20 SC 1000 mg during the treatment period. During the treatment period, visits are every 12 weeks.
Eligibility Criteria
- Inclusion Criteria: Adults that have completed ARGX-113-2007 Participants capable of providing signed informed consent Participants agrees to use contraceptive measures Exclusion Criteria: Participants with intention of having major surgery during the ARGX-113-2011 study period Known hypersensitivity to IMP Permanent discontinuation of IMP in ARGX-113-2007
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