NCT05405361进行中（未招募）2 期
A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- argenx
- 入组人数
- 51
- 试验地点
- 27
- 主要终点
- Safety outcomes based on adverse event (AE) monitoring.
研究概览
简要总结
This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
During the double-blinded rollover treatment period (DTP),the investigator, trial nurse/coordinator, participant, and the sponsor's designated contract research organization (CRO), and sponsor trial team (except the sponsor's clinical trial supplies team) are blinded to IMP. The interactive response technology (IRT) system is used for blinding.
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
- •Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
- •Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117.
排除标准
- •Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
- •Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
- •Currently participating in another interventional clinical study.
- •Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.
研究组 & 干预措施
ARGX-117
Experimental
Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP)
干预措施: ARGX-117 (Biological)
Placebo
Experimental
Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP)
干预措施: ARGX-117 (Biological)
Placebo
Experimental
Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP)
干预措施: Placebo (Other)
结局指标
主要结局
Safety outcomes based on adverse event (AE) monitoring.
时间窗: Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first
次要结局
- Change from baseline in the mMRC-10 sum score(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Proportion of participants showing a deterioration of at least 2 points in mMRC-10 sum score(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in the mMRC-14 sum score(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Proportion of participants showing a deterioration of at least 2 points in the mMRC-14 sum score(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in the average score of the 2 most important muscle groups as assessed by the mMRC-14 sum score(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in GS(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Proportion of participants with a decline of >30% in GS(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in the MMN-RODS(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in the average time for the upper extremity (arm and hand) function (9-HPT, or timed pegboard test)(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Proportion of participants by level of severity on each dimension of the EQ-5D-5L(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in EQ-5D-5L visual analog scale (VAS)(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in the CAP-PRI(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in the 9-item FSS(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Values of the PGIC scale(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Proportion of participants by level of severity of MMN as assessed by PGIS(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Values for work-related and household chore activities of the HRPQ(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Serum concentrations for ARGX-117(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Change from baseline in free C2, total C2, functional complement activity (CH50).(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
- Incidence of antidrug antibodies (ADA) against ARGX-117(Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first)
研究者
研究点 (27)
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