An Adaptive, Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AC Immune SA
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson's disease.
详细描述
This is a prospective, multicenter, placebo-controlled, double-blind, randomized study with adaptive features, comprising a screening period of up to 8 weeks, a 74-week double-blind treatment period, and a 26-week post-treatment follow-up period.
Up to 3 cohorts will include 16 subjects each (12 under the study treatment and 4 under placebo; 3:1 active treatment/placebo ratio). One of the initial potential 3 cohorts (Cohorts 2 and 3 are optional) may be expanded in order to reach an overall total of up to 150 subjects in the study. In case a cohort is expanded, the randomization ratio will be adjusted to achieve an active treatment/placebo ratio of 2:1 in this cohort.
The route of administration of the study treatment and placebo will be by intramuscular injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Early PD subjects receive placebo at pre-defined time points over 74 weeks.
干预措施: Placebo (Biological)
ACI-7104.056 at Dose A
Early PD subjects receive dose A of ACI-7104.056 at pre-defined time points over 74 weeks.
干预措施: ACI-7104.056 at Dose A (Biological)
ACI-7104.056 at Dose B (optional)
Early PD subjects receive dose B of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
干预措施: ACI-7104.056 at Dose B (optional) (Biological)
ACI-7104.056 at Dose C (optional)
Early PD subjects receive dose C of ACI-7104.056 at pre-defined time points over 74 weeks. This arm is optional.
干预措施: ACI-7104.056 at Dose C (optional) (Biological)
结局指标
主要结局
Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)
时间窗: From Screening (ICF signature) to Week 100
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056
时间窗: From Baseline to Week 100
Number of participants with abnormal MRI results
时间窗: From Baseline to Week 100
Number of participants with clinically significant changes in physical and neurological examination results
时间窗: From Baseline to Week 74
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: From Baseline to Week 100
次要结局
- Measures of alpha-synuclein (a-syn) related biofluid biomarkers(From Baseline to Week 100)
- Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III(From Baseline to Week 100)
- Measurement of levels of dopamine transporter proteins in specific brain regions, notably substantia nigra, by Dopamine Transporter-Single Photon Emission Computerized Tomography (DaT-SPECT) imaging(From Baseline to Week 100)