2023-507052-69-00招募中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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Argenx
- 入组人数
- 34
- 试验地点
- 17
- 主要终点
- Safety outcomes based on AE monitoring and other safety assessments (clinical laboratory tests)
研究概览
简要总结
To evaluate the long-term safety and tolerability of ARGX-117 in adult participants with Multifocal Motor Neuropathy (MMN)
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open-label treatment period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants are eligible to be included in the trial only if all of the following criteria apply:
- •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
- •Agrees to use contraceptive measures consistent with local regulations and the following: a. Male participants: must use an acceptable contraceptive method that should be maintained at minimum until 15 months after last dose of Investigational Medicinal Product (IMP). b. Female participants (women) of childbearing potential must have a negative urine pregnancy test at baseline before IMP can be administered.
排除标准
- •Participants will be excluded from the trial if any of the following criteria apply:
- •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 IMP.
结局指标
主要结局
Safety outcomes based on AE monitoring and other safety assessments (clinical laboratory tests)
Safety outcomes based on AE monitoring and other safety assessments (clinical laboratory tests)
次要结局
- 1. Modified Medical Research Council (mMRC) − Value and change from baseline in the mMRC-10 sum score − Proportion of participants showing a deterioration of at least 2 points in mMRC-10 sum score − Value and change from baseline in the mMRC-14 sum score − Proportion of participants showing a deterioration of at least 2 points in the mMRC-14 sum score
- − Value and change from baseline in the average score of the 2 most important muscle groups as assessed by the mMRC-14 sum score
- 2. Grip strength (GS) − Values, change, and percent change from baseline in GS − Proportion of participants with a decline of >30% in GS
- 3. Values and change from baseline in the Rasch-built overall disability scale for MMN (MMN‐RODS)
- 4. Values, change, and percentage change from baseline in the average time for the upper extremity (arm and hand) function (9-Hole Peg Test [9-HPT], or timed pegboard test)
- 5. Proportion of participants by level of severity on each dimension of EQ-5D-5L
- 6. Value and change from baseline in EQ-5D-5L visual analog scale (VAS)
- 7. Values and change from baseline in the Chronic Acquired Polyneuropathy Patient-Reported Index (CAP-PRI)
- 8. Values and change from baseline in the 9-item Fatigue Severity Scale (FSS)
- 9. Values of the Patient Global Impression of Change (PGIC) scale
- 10. Proportion of participants by level of severity of MMN as assessed by the Patient Global Impression of Severity (PGIS)
- 11. Values for work-related and household chore activities of the Health-Related Productivity Questionnaire (HRPQ) at each visit: − Hours lost because of absenteeism − Hours lost because of presenteeism
- − Total hours lost − Percent of scheduled hours lost because of absenteeism − Percent of scheduled hours lost because of presenteeism − Percent of scheduled hours lost in total
- 12. Serum concentrations and PK parameters for ARGX-117
- 13.Values and change from baseline in free C2, total C2, and functional complement activity (CH50) over time
- 14. Incidence and prevalence of antidrug antibodies (ADA) against ARGX-117
研究者
Chief Scientific Officer
Scientific
Argenx
研究点 (17)
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