NCT07174310招募中3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 900
- 试验地点
- 192
- 主要终点
- Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight within 40-110 kilograms (kg) (88-242 pounds [lbs]) and a body mass index within the range 18-34 kg/m2
- •Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
- •Has received monotherapy treatment
- •An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
- •Hoehn and Yahr (H&Y) Stage 1 or 2 off medication at screening and prior to randomization
- •Agreement to adhere to the contraception requirements
排除标准
- •Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
- •Medical history indicating a parkinsonian syndrome other than idiopathic PD
- •Diagnosis of a significant neurologic disease other than PD
- •Chronic uncontrolled hypertension
研究组 & 干预措施
Placebo
Experimental
Participants will receive placebo as an IV Infusion.
干预措施: Placebo (Drug)
Prasinezumab
Experimental
Participants will receive Prasinezumab as an IV infusion in the double blind treatment period. Upon completion, eligible participants will enter into the Open Label Extension (OLE) phase.
干预措施: Prasinezumab (Drug)
结局指标
主要结局
Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
时间窗: Up to at least Week 104
次要结局
- Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale(Up to at least Week 104)
- Time to increase in Levodopa Equivalent Daily Dose (LEDD)(Up to at least Week 104)
- Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score(Baseline, Week 104)
- Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event(Up to at least Week 104)
- Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
- Percentage of Participants With Adverse Events of Special Interest (AESI)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
- Percentage of Participants With Infusion Related Reactions (IRRs)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
- Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)(From Baseline up to 70 days after the final study dose (up to at least Week 104))
- Serum Concentration of Prasinezumab(Predose and postdose at Baseline, Week 1, 4, 12, 24, 36, 52, 76, and after week 76 every 12 weeks thereafter until end of study (up to at least Week 104))
- Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline(At Baseline)
- Percentage of Participants With ADAs Against Prasinezumab During the Study(From Baseline up to 70 days after the final study dose (up to at least Week 104))
研究者
研究点 (192)
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