A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com
详细描述
This is a 12-Week, randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of three IkT 148009 doses in patients with untreated PD designed to assess safety, tolerability, and pharmacokinetics of IkT-148009, an oral, once daily c-Abl tyrosine kinase inhibitor. Secondary and exploratory assessments will evaluate the effect of IkT-148009 on motor and non-motor features of the disease. 120 participants are anticipated to be enrolled at up to 34 sites across the US.
Participants will undergo screening to evaluate their eligibility to participate in the study to include evaluation of Parkinson's diagnosis, vital signs, blood chemistry, hematology and urinalysis and complete listing of concomitant medications. An Enrollment Authorization Committee (EAC) will be responsible for reviewing screening data and confirming the eligibility and suitability of participants. Those selected will be enrolled and randomized to one of three active IkT-148009 arms (50/100/200 mg) or a placebo arm (1:1:1:1). All clinical staff, study investigators, and participants will be blinded to study assignments throughout the trial.
A Data Safety Monitoring Committee (DSMB) will evaluate all available safety, tolerability, and PK and Parkinson's disease-related data for each cohort on a monthly to quarterly basis. Adverse event reporting will be evaluated in real-time.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 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
50mg IkT-148009 (risvodetinib)
This arm consisted of participants treated with the 50mg dose of risvodetinib.
干预措施: IkT-148009 (risvodetinib) (Drug)
100mg IkT-148009 (risvodetinib)
This arm consisted of participants treated with the 100mg dose of risvodetinib.
干预措施: IkT-148009 (risvodetinib) (Drug)
200mg IkT-148009 (risvodetinib)
This arm consisted of participants treated with the 200mg dose of risvodetinib.
干预措施: IkT-148009 (risvodetinib) (Drug)
Placebo
This arm consisted of participants treated with placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (TEAEs)
时间窗: Baseline to 12 weeks
Proportion of Those Randomized in Each Dosing Cohort Who Discontinued the Assigned Regimen Due to an Adverse Event
时间窗: Baseline to 12 weeks
次要结局
- LS Mean of Change From Baseline in PGI-S From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in CSBM Score From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in PAGI-SYM From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in PAC-QoL From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in PAGI-QoL From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in MDS-UPDRS Part II+III From a Mixed Model for Repeated Measures(Baseline to Week 12)
- LS Mean of Change From Baseline in PDQ-39 From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in CGI-S From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in NMSS From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in MDS-UPDRS Part II From a Mixed Model for Repeated Measures(Baseline to 12 weeks)
- LS Mean of Change From Baseline in MDS-UPDRS Part III From a Mixed Model for Repeated Measures(Baseline to 12 weeks)
- LS Mean of Change From Baseline in MDS-UPDRS Part I From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in ESS From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)
- LS Mean of Change From Baseline in SE-ADL From a Mixed Model for Repeated Measures(Change from Baseline to Week 12)