jRCT2031240524招募中不适用
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 (alkivia+)
argenx BV (ICCC: ICON Clinical Research GK)0 个研究点目标入组 22 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 主要终点
- Incidence and severity of TEAEs, AESIs, and SAEs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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-
- •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
结局指标
主要结局
Incidence and severity of TEAEs, AESIs, and SAEs
Incidence and severity of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Changes and abnormalities in vital signs, ECG, and laboratory parameters
Changes and abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters
次要结局
未报告次要终点
研究者
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