NCT06742190进行中（未招募）3 期
A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Empasiprubart Versus Intravenous Immunoglobulin in Adults With Multifocal Motor Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- argenx
- 入组人数
- 154
- 试验地点
- 194
- 主要终点
- Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24
研究概览
简要总结
The main purpose of this study is to compare empasiprubart and IVIg in adult patients with MMN. The study consists of a double-blinded part A (empasiprubart, IVIg) and an open-label part B (empasiprubart). The maximum study duration for participants is up to 49 months.
More information can be found here: https://clinicaltrials.argenx.com/empassion
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 for clinical studies
- •Has a confirmed diagnosis of definite or probable MMN at screening according to the EFNS/PNS 2010 guidelines
- •Has responded to IVIg in the past 5 years.
- •Is receiving IVIg at a treatment interval of once every 2, 3, 4, or 5 weeks, and a dose of 0.4 to 2.0 g/kg body weight per cycle
- •Is receiving a maintenance regimen (no change in frequency, and no change in dose >10%) of IVIg for at least 8 weeks before screening (or at least 10 weeks for participants receiving IVIg once every 5 weeks)
- •Minimum converted weekly IVIg dose of ≥0.125 g/kg
- •Has documented immunization against encapsulated bacterial pathogens (N meningitidis and S pneumoniae) within 5 years of screening or is willing to receive immunization at least 14 days before first study drug administration
排除标准
- •Besides the indication under study, known autoimmune disease (eg, SLE) or any other medical condition that would confound the study results or put the participant at undue risk
- •Clinical signs or symptoms suggestive of neuropathies other than MMN, such as motor neuron disease (eg, bulbar signs, brisk reflexes) or other inflammatory neuropathies (eg, sensory neuropathy)
研究组 & 干预措施
Part A - empasiprubart + IVIg-placebo
Experimental
During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm
干预措施: Empasiprubart (Biological)
Part B - empasiprubart
Experimental
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg)
干预措施: Empasiprubart (Biological)
Part A - empasiprubart + IVIg-placebo
Experimental
During the double blinded - double dummy part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm
干预措施: IVIg-placebo (Other)
Part A - IVIg + empasiprubart-placebo
Active Comparator
During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm
干预措施: IVIG (Intravenous Immunoglobulin) (Biological)
Part A - IVIg + empasiprubart-placebo
Active Comparator
During the double blinded - double dummy part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm
干预措施: Empasiprubart-placebo (Other)
结局指标
主要结局
Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24
时间窗: Up to 24 weeks
次要结局
- Change from baseline in CAP-PRI total score(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Percentage change from baseline in time to complete the 9-HPT with the dominant hand(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Incidence of AEs, AESIs and SAEs(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Serum concentrations over time of empasiprubart(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Percent changes from baseline in free C2 and total C2 over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Incidence of anti-drug antibodies (ADA) against empasiprubart in serum(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Incidence of NAb against empasiprubart in serum(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in grip strength (3-day moving average) of the least affected hand over time(Up to 24 weeks)
- AUC of change from baseline in grip strength (3-day moving average) for the most and least affected hands(Up to 24 weeks)
- Percentage change from baseline in time to complete the 9-HPT with the nondominant hand over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in sum scores for mMRC-10 and mMRC-14 restricted to the 2 most affected muscle groups over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Proportion of participants and shift from baseline over time by level of severity on PGI-S(Up to 24 weeks)
- Change from baseline in Rasch-Transformed Fatigue Severity Scale (RT-FSS) score over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in physical component and mental component scores of 12-Item Short Form Survey (SF-12) over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Proportion of participants and shift from baseline by each dimension of the EQ-5D-5L scale(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Changes from baseline in MMN-RODS centile score(Up to 120 weeks (part B))
- Changes from baseline in grip strength (3-day moving average; both hands)(Up to 120 weeks (part B))
- Actual values of PGI-S over time(Up to 120 weeks (part B))
- Change from baseline in grip strength (3-day moving average) in the most affected hand at week 24(Up to 24 weeks)
- PGI-C actual value(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in mMRC-14 sum score(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in mMRC-14 sum score(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in MMN-RODS centile score at week 24(Up to 24 weeks)
- PGI-C actual value(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in CAP-PRI total score(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Incidence of AEs, AESIs and SAEs(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Incidence of NAb against empasiprubart in serum(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Percentage change from baseline in time to complete the 9-HPT with the dominant hand(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Percent changes from baseline in free C2 and total C2 over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Incidence of anti-drug antibodies (ADA) against empasiprubart in serum(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- AUC of change from baseline in grip strength (3-day moving average) for the most and least affected hands(Up to 24 weeks)
- Proportion of participants and shift from baseline over time by level of severity on PGI-S(Up to 24 weeks)
- Serum concentrations over time of empasiprubart(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in grip strength (3-day moving average) of the least affected hand over time(Up to 24 weeks)
- Change from baseline in sum scores for mMRC-10 and mMRC-14 restricted to the 2 most affected muscle groups over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Actual values of PGI-S over time(Up to 120 weeks (part B))
- Percentage change from baseline in time to complete the 9-HPT with the nondominant hand over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Change from baseline in Rasch-Transformed Fatigue Severity Scale (RT-FSS) score over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Changes from baseline in MMN-RODS centile score(Up to 120 weeks (part B))
- Changes from baseline in grip strength (3-day moving average; both hands)(Up to 120 weeks (part B))
- Change from baseline in physical component and mental component scores of 12-Item Short Form Survey (SF-12) over time(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
- Proportion of participants and shift from baseline by each dimension of the EQ-5D-5L scale(Up to 24 weeks (Part A), Up to 120 weeks (Part B))
研究者
研究点 (194)
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