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临床试验/NCT05919823
NCT05919823已完成3 期

A Phase 3, Multicenter, Two-part Study With a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) Followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects With DSM-5 Schizophrenia

Karuna Therapeutics28 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2023年5月29日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
202
试验地点
28
主要终点
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 5 of the Double-Blind Period
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A Phase 3, Multicenter, Two-part Study with a 5-week Double-blind Part (Randomized, Parallel-group, Placebo-controlled) followed by a 12-week Open-label Extension Part, to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Hospitalized Chinese Adult Subjects with DSM-5 Schizophrenia

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, 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

  • •Subject is Chinese national, aged 18 to 65 years, inclusive, at screening.
  • •Subject is capable of providing written informed consent.
  • •Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 and MINI.
  • •Subject is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening.
  • •The subject requires hospitalization for this acute exacerbation or relapse of psychotic symptoms at screen.
  • •If already an inpatient at screening, hospitalization has to be ≤2 weeks for the current exacerbation at the time of screening.
  • •PANSS total score between 80 and 120,inclusive, with a scores of ≥4 (moderate or greater) for ≥2 of the following Positive Scale (P) items:
  • •Item 1 (P1; delusions)
  • •Item 2 (P2; conceptual disorganization)
  • •Item 3 (P3; hallucinatory behavior)
  • •Item 6 (P6; suspiciousness/persecution)
  • •Subjects with no change (improvement) in PANSS total score between screening and baseline (Day -1) of more than 20%.
  • •Subject has a CGI-S score of ≥4 at screening and baseline (Day -1) visits.
  • •Subject will have been off lithium therapy for at least 2 weeks before baseline and free of all oral antipsychotic medications for at least 5 half-lives or 1 week, whichever is longer, before baseline (Day -1).
  • •Subjects taking a long-acting injectable antipsychotic could not have received a dose of medication for at least 12 weeks (24 weeks for INVEGA TRINZA®) before baseline visit (Day -1).
  • •Subject is able to be confined to an inpatient setting for the duration of the 5-week double-blind part of the study, follow instructions, and comply with the protocol requirements.
  • •Body mass index of 18 to 40 kg/m2, inclusive.
  • •Subject resides in a stable living situation and is anticipated to return to that same stable living situation after discharge, in the opinion of the investigator.
  • •Subject has an identified reliable informant. An informant is needed at the screening and baseline visits as well as at the end of the study for relevant assessments (site staff may act as informant while the subject is an inpatient). An informant may not be necessary if the subject has been a patient of the investigator for ≥1 year.
  • •Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be willing and able to adhere to the contraception guidelines.

排除标准

  • •Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
  • •Subjects who are newly diagnosed or are experiencing their first treated episode of schizophrenia.
  • •History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
  • •Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or liver function test results.
  • •History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
  • •History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  • •Risk for suicidal behavior during the study as determined by the investigator's clinical assessment and C-SSRS.
  • •Clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results at screening that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
  • •Subjects are receiving or have recently received (within 5 half-lives or 1 week, whichever is longer, before baseline [Day -1]) oral antipsychotic medications; monoamine oxidase inhibitors; anticonvulsants (e.g., lamotrigine, valproate); tricyclic antidepressants (e.g., imipramine, desipramine); selective serotonin reuptake inhibitors; or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate).
  • •Subjects are receiving or have recently received (within 1 week before baseline [Day -1]) metformin.
  • •Pregnant, lactating, or less than 3 months postpartum.
  • •In the opinion of the investigator and/or Sponsor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the investigator and/or Sponsor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements.
  • •Subject has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.
  • •Subject has a history of treatment resistance to schizophrenia medications defined as failure to respond to 2 adequate courses of pharmacotherapy (a minimum of 4 weeks at an adequate dose per the label) or has required clozapine within the last 12 months.
  • •Subjects with prior exposure to KarXT.
  • •Subjects who experienced any significant adverse effects due to trospium chloride.
  • •Participation in another clinical study within 3 months before screening in which the subject received an experimental or investigational drug agent.
  • •Significant risk of violent or destructive behavior.

研究组 & 干预措施

KarXT

Experimental

干预措施: Xanomeline and Trospium Chloride Capsules (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 5 of the Double-Blind Period

时间窗: At Baseline and at Week 5 of the Double-Blind Period

PANSS Total Score is a clinical tool used to measure the severity of symptoms in individuals with schizophrenia. It includes 30 items divided into three subscales: Positive Symptoms (e.g., hallucinations, delusions) Negative Symptoms (e.g., social withdrawal, lack of motivation) General Psychopathology (e.g., anxiety, depression) Each item is rated from 1 (absent) to 7 (extreme), resulting in a total score range from 30 to 210. Higher PANSS Total Scores indicate more severe symptoms and worse clinical outcomes. Baseline is defined as last non-missing assessment prior to the first dose of study drug.

次要结局

  • Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period(At Baseline and at Week 5 of the Double-Blind Period)
  • Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period(At Baseline and at Week 5 of the Double-Blind Period)
  • Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 5 of the Double-Blind Period(At Baseline and at Week 5 of the Double-Blind Period)
  • Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 5 of the Double-Blind Period(At Baseline and at Week 5 of the Double-Blind Period)
  • Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 5 of the Double-Blind Period(At Baseline and at Week 5 of the Double-Blind Period)
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Week 12 of the Open-Label Period(At Baseline and at Week 12 of the Open-Label Period)
  • Change From Baseline in Positive Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period(At Baseline and at Week 12 of the Open-Label Period)
  • Change From Baseline in Negative Symptom Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period(At Baseline and at Week 12 of the Open-Label Period)
  • Change From Baseline in Negative Marder Factor Score of the Positive and Negative Syndrome Scale (PANSS) at Week 12 of the Open-Label Period(At Baseline and at Week 12 of the Open-Label Period)
  • Change From Baseline in Clinical Global Impressions - Severity (CGI-S) Score at Week 12 of the Open-Label Period(At Baseline and at Week 12 of the Open-Label Period)
  • Percentage of PANSS Responders (≥30% Change in PANSS Total Score From Baseline) at Week 12 of the Open-Label Period(At Baseline and at Week 12 of the Open-Label Period)
  • Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Drug Withdrawal(From first dose until study completion (up to approximately 18 weeks))
  • Number of Participants With Orthostatic Vital Sign Events(From first dose until study completion (up to approximately 18 weeks))
  • Number of Participants With Elevated Liver Function Test Results(At study baseline, Day 21 DB, Day 35 DB, open-label baseline, Day 14 OL, Day 84 OL, and end of study visit (up to approximately 18 weeks))
  • Number of Participants With Elevated Metabolic Syndrome Parameters(At study baseline, Day 21 DB, Day 35 DB, open-label baseline, Day 14 OL, Day 84 OL, and end of study visit (up to approximately 18 weeks))
  • Number of Participants With Abnormal Electrocardiogram (ECG) Results(At study baseline and up to study completion (up to approximately 18 weeks))
  • Number of Participants With Suicidal Ideation as Defined by a Columbia-Suicide Severity Rating Scale (C-SSRS) Ideation Score of 1 or Greater(From first dose to study completion (up to approximately 18 weeks))
  • Number of Participants With Clinically Meaningful Changes in Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BARS), and Abnormal Involuntary Movement Scale (AIMS) Results(At study baseline, open-label baseline, and up to study completion (up to approximately 18 weeks))
  • Change From Baseline in Body Weight(At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 weeks))
  • Change From Baseline in Body Mass Index (BMI)(At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 weeks))
  • Change From Baseline in Waist Circumference(At study baseline, Day 35 DB, open-label baseline, Day 84 OL, and end of study visit (up to approximately 18 months))
  • Area Under the Concentration-Time Curve (AUC0-12) of Xanomeline and Trospium - Double-Blind Period(On Day 28 of the Double-Blind Period)
  • Maximum Observed Plasma Concentration (Cmax) of Xanomeline and Trospium - Double-Blind Period(On Day 28 of the Double-Blind Period)
  • Time to Cmax (Tmax) of Xanomeline and Trospium - Double-Blind Period(On Day 28 of the Double-Blind Period)

研究者

发起方
Karuna Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (28)

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