An Open-Label, Single-Arm, Phase 1b Study to Evaluate the Effect of Empasiprubart on Nerve Morphology by Ultrasound in Adults With Multifocal Motor Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Change from baseline in nerve CSA at week 24 as measured by ultrasound imaging of the median nerve and brachial plexus (individual nerves and average sum score)
研究概览
简要总结
The main purpose of the study is to evaluate empasiprubart use in adults living with Multifocal Motor Neuropathy (MMN). The researchers will evaluate the effect of empasiprubart on the thickness of the nerves, muscle strength, movement, and on the potential improvement of grip strength of the participants in handling objects.
The study consists of an open-label treatment period where all participants will receive empasiprubart intravenously (IV). After the last dose of empasiprubart participants will enter a safety follow-up period for up to 15 months.
The total study duration for each participant will be approximately 29 months.
More information can be found here: clinicaltrials.argenx.com/empasound
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 old
- •Diagnosed with MMN
- •Has an MMN-RODS centile score of ≤90
- •Has confirmed nerve thickening in at least 1 nerve per ultrasound measurement
排除标准
- •Besides the indication under study, known autoimmune disease or any medical condition that, in the investigator's opinion, would interfere with an accurate assessment of clinical symptoms of MMN or puts the participant at undue risk.
研究组 & 干预措施
Empasiprubart IV
Participants receive empasiprubart IV
干预措施: Empasiprubart IV (Biological)
结局指标
主要结局
Change from baseline in nerve CSA at week 24 as measured by ultrasound imaging of the median nerve and brachial plexus (individual nerves and average sum score)
时间窗: Up to 48 weeks
CSA : cross-sectional area
次要结局
- Change from baseline in GS in both hands over time(Up to 48 weeks)
- Change from baseline in MMN-RODS over time(Up to 48 weeks)
- Incidence of AEs and AESIs(Up to 60 weeks)
- Incidence of SAEs(Up to 60 weeks)
- Change from baseline in mMRC-14 sum score over time(Up to 48 weeks)
- Percentage change from baseline in time to complete the 9-HPT with both hands over time(Up to 48 weeks)
- Change from baseline in nerve CSA over time as measured by ultrasound imaging of the median nerve and brachial plexus(Up to 48 weeks)
- Serum concentrations of empasiprubart over time(Up to 60 weeks)
- Percentage change from baseline in free C2 and total C2 over time(Up to 60 weeks)