NCT07638566尚未招募2 期
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- argenx
- 入组人数
- 6
研究概览
简要总结
The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP.
The study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately.
The overall study duration for each participant is up to 43 months.
More information can be found here: clinicaltrials.argenx.com/emlight
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is aged 12 to <18 years.
- •Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- •Has a diagnosis of either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP.
排除标准
- •Possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- •Sensory CIDP (including sensory-predominant CIDP).
- •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 that puts the participant at undue risk.
- •Prior use of other long-acting immunomodulatory treatment.
研究者
相似试验
招募中
1 期
A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult ParticipantsNCT07612020argenx130
进行中（未招募）
1 期
A Study of Eltrekibart (LY3041658) in Healthy ParticipantsHealthyNCT07545590Eli Lilly and Company60
尚未招募
3 期
An Open-label Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of 12-month Treatment with Migalastat in Pediatric Subjects (aged 2 to < 12 years) with Fabry Disease and Amenable GLA VariantsFabry disease2025-521244-38-00Amicus Therapeutics Inc.1
招募中
1 期
Pharmacokinetics of Olverembatinib in Participants With Hepatic ImpairmentNCT07282093Ascentage Pharma Group Inc.48
招募中
2 期
Phase 2a Study of Luspatercept in Pediatric Participants With Beta (β)-Thalassemia2022-502499-22-00Celgene Corp.57