NCT07032662招募中2 期
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 264
- 主要终点
- Proportion of participants remaining Relapse-free by Week 24
研究概览
简要总结
This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Imeroprubart in adult participants with active CIDP.
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
- Double (Participant, Investigator)
盲法说明
Sponsor, care provider and outcome assessor will also be blinded.
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
- •Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP.
- •Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- •Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.
- •Additional inclusion criteria are defined in the protocol.
排除标准
- •Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
- •Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- •Have polyneuropathy of causes other than CIDP including but not limited to:
- •Multifocal motor neuropathy
- •Hereditary demyelinating neuropathy
- •Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)
- •Lumbosacral radiculoplexus neuropathy
- •Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies
- •Drug- or toxin-induced
- •Have diabetes mellitus (DM) and meets any of the following criteria:
- •Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.
- •In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.
- •In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
- •Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.
研究组 & 干预措施
Imeroprubart
Experimental
干预措施: Imeroprubart (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants remaining Relapse-free by Week 24
时间窗: Baseline, Week 24
Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline.
次要结局
- Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS)(Baseline and Up to Week 24)
- Change from baseline to Week 24 in Mean Grip Strength in the dominant hand(Baseline and Up to Week 24)
- Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS)(Baseline and Up to Week 24)
- Change from baseline to Week 24 in aINCAT score(Baseline and Up to Week 24)
研究者
研究点 (264)
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