A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 218
- 试验地点
- 88
- 主要终点
- Reduction of ≥1 point compared with baseline in aINCAT score at week 24
研究概览
简要总结
The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).
More information can be found here: https://clinicaltrials.argenx.com/emvigorate
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
- •Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- •Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
- •Has responded to IVIg in the past 5 years
- •Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg
- •Has residual disability and active disease
排除标准
- •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 puts the participant at undue risk, including polyneuropathy of other causes
- •Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
- •Use of other long-acting immunomodulatory treatment
研究组 & 干预措施
Part A - IVIg + empasiprubart-placebo
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
干预措施: empasiprubart-placebo (Other)
Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.
干预措施: empasiprubart (Biological)
Part A - IVIg + empasiprubart-placebo
During Part A, participants receive IVIg and a placebo resembling the empasiprubart treatment in this arm.
干预措施: IVIg (Biological)
Part A - empasiprubart + IVIg-placebo
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
干预措施: IVIg-placebo (Other)
Part A - empasiprubart + IVIg-placebo
During Part A, participants receive empasiprubart and a placebo resembling the IVIg treatment in this arm.
干预措施: empasiprubart (Biological)
Part B - empasiprubart
After completion of part A, participants can proceed to part B where they receive empasiprubart (no IVIg). Participants from the empasiprubart + IVIg- placebo arm in Part A will receive empasiprubart placebo once to maintain the blind of Part A.
干预措施: empasiprubart-placebo (Other)
结局指标
主要结局
Reduction of ≥1 point compared with baseline in aINCAT score at week 24
时间窗: up to 24 weeks
The Adjusted Inflammatory Neuropathy Cause and Treatment Disability Score (aINCAT) score is a 10-point scale that covers the functionality of legs and arms. The score varies between 0 and 10 (higher score, worse outcome).
次要结局
- Change from baseline in grip strength (3-day moving average) in the dominant hand at week 24(up to 24 weeks)
- Change from baseline in TUG at week 24(up to 24 weeks)
- Change from baseline in I-RODS centile points score at week 24(up to 24 weeks)
- Time to increase of ≥1 point compared with baseline in aINCAT score(Up to 24 weeks)
- Change from baseline in aINCAT over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- Change from baseline in RT-FSS over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- Change from baseline in SF-12 over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- Change from baseline in MRC-SS at week 24(up to 24 weeks)
- Change from baseline in grip strength (3-day moving average) of both hands over time(up to 24 weeks + 96 weeks (Part B))
- Change from baseline in BPI-SF over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- PGI-C values over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- Values for work-related and household chore activities of the HRPQ(up to 24 weeks)
- Percentage of scheduled hours lost in total (absenteeism+ presenteeism)(up to 24 weeks)
- Time to reduction of ≥1 point from baseline in aINCAT score(up to 24 weeks)
- Change from baseline in EQ-5D-5L over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- PGI-S values over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- Change from baseline in grip strength (daily average) for both hands(up to 24 weeks + 96 weeks (Part B))
- Change from baseline in MRC-SS over time(up to 96 weeks (Part B))
- Change from baseline in I-RODS centile points score over time(Up to 96 weeks (Part B))
- Change from baseline in TUG over time(Up to 96 weeks (Part B))
- Incidence of antidrug antibodies against empasiprubart in serum(up to 24 weeks (Part A) + 96 weeks (Part B))
- Incidence of neutralizing antibodies against empasiprubart in serum(up to 24 weeks (Part A) + 96 weeks (Part B))
- Incidence of (serious) adverse events(up to 24 weeks (Part A) + 96 weeks (Part B))
- Percentage change from baseline in free C2 and total C2 over time(up to 24 weeks (Part A) + 96 weeks (Part B))
- Serum concentrations of empasiprubart over time(up to 24 weeks (Part A) + 96 weeks (Part B))