NCT06602193进行中（未招募）2 期
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 36
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
研究概览
简要总结
This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
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)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
- •For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
- •Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
- •Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.
排除标准
- •Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
- •Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
- •Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
- •Have previously participated or are currently participating in a gene therapy study for PD.
- •Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
- •Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).
- •Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
- •Have abnormal PFT results at screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
BIIB122 225 mg
Experimental
Oral 225 mg dose, once daily (QD)
干预措施: BIIB122 225 mg (Drug)
BIIB122 Matching Placebo
Placebo Comparator
Oral BIIB122 matching placebo, once daily (QD)
干预措施: BIIB122-Matching Placebo (Other)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) with BIIB122 compared with placebo over the 12-week double-blind period
时间窗: 12 weeks
次要结局
- Change from baseline in whole-blood pS935 LRRK2 with BIIB122 compared with placebo at Week 12(12 weeks)
- Change from baseline in urine BMP with BIIB122 compared with placebo at Week 12(12 weeks)
研究者
研究点 (36)
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