NCT07686263招募中3 期
A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
Karuna Therapeutics, Inc., a Bristol Myers Squibb company120 个研究点 分布在 7 个国家目标入组 472 人开始时间: 2026年8月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 472
- 试验地点
- 120
- 主要终点
- Time From Randomization to the First Relapse Event
研究概览
简要总结
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
- •Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
- •Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -
- •Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
- •Item 1 (P1; delusions)
- •Item 2 (P2; conceptual disorganization)
- •Item 3 (P3; hallucinatory behavior)
- •Item 6 (P6; suspiciousness/persecution)
- •Participant must have a CGI-S score of ≥ 4 at screening and Day -1
- •Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.
排除标准
- •Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
- •Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
- •Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
- •Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
- •Participant must not have a history of treatment resistance to schizophrenia medications
- •Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
KarXT
Experimental
干预措施: Xanomeline/Trospium Chloride (Drug)
结局指标
主要结局
Time From Randomization to the First Relapse Event
时间窗: Up to approximately Week 43
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to approximately Week 45)
- Number of Participants With Adverse Events of Special Interest (AESIs)(Up to approximately Week 45)
- Number of Participants With Procholinergic Symptoms(Up to approximately Week 45)
- Number of Participants With Anticholinergic Symptoms(Up to approximately Week 45)
- Number of Participants With Serious Adverse Events (SAEs)(Up to approximately Week 45)
- Time to Discontinuation During Double-blind Treatment Period(Approximately From Week 18 to 43)
研究者
研究点 (120)
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