PER-032-23招募中3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Argenx BV
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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).
排除标准
- 未提供
研究者
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