NCT06637072已完成4 期
A Phase 4, Open-Label, Single-Group, Multicenter Study in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy Who Transition From Treatment With Intravenous Immunoglobulin to Efgartigimod PH20 SC
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 23
- 试验地点
- 13
- 主要终点
- Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period
研究概览
简要总结
This study will measure how adults with CIDP receiving IVIg treatment adjust to efgartigimod PH20 SC. The study duration for each participant will be approximately 17 to 19 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age and the local legal age of consent
- •Is diagnosed with CIDP (confirmed or possible CIDP) according to the criteria of the European Academy of Neurology/Peripheral Nerve Society
- •Is being treated with IVIg every 3-6 weeks, on a stable dose and dosing interval (between 0.5-2 g/kg) for at least 3 doses
- •If receiving oral corticosteroids, this should be at a stable dose of less than 20 mg a day or less than 40 mg every other day, for at least a month.
- •If receiving nonsteroidal immunosuppressive medication, this should be at a stable dose for at least 3 months
排除标准
- •Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk
- •Types of other polyneuropathy other than CIDP
研究组 & 干预措施
Efgartigimod PH20 SC
Experimental
Participants start efgartigimod PH20 SC treatment after discontinuing IVIg
干预措施: Efgartigimod PH20 SC (Biological)
结局指标
主要结局
Proportion of participants who begin treatment with efgartigimod PH20 SC within 1 week after stopping IVIg therapy and are still receiving efgartigimod PH20 SC at the end of the 12-week treatment period
时间窗: Up to 12 weeks
次要结局
- Changes from baseline in PGI-C scores over time(Up to 12 weeks)
- Changes from baseline in EQ-5D-5L scores over time(Up to 12 weeks)
- Changes from baseline in TSQM-9 scores over time(Up to 12 weeks)
- Changes from baseline in PGI-S scores over time(Up to 12 weeks)
- Incidence of (S)AEs(Up to 16 weeks)
研究者
研究点 (13)
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