临床试验/NCT05227703

NCT05227703已完成2 期

A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis

AbbVie25 个研究点分布在 3 个国家目标入组 391 人开始时间: 2022年7月5日最近更新: 2025年10月28日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 391
试验地点: 25
主要终点: Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

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相关资讯

研究概览

简要总结

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female adult participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.

详细描述

The trial included up to a 15-day Screening Period (up to a maximum of 21 days allowed with approval of the medical monitor), a 45-day Inpatient Treatment Period, and a 28-day Follow-up Period. Each participant participated in the trial for up to approximately 13 weeks.

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: Double (Participant, Investigator)

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

•Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.
•CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.
•PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline.
•Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
•Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
•Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).
•Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

排除标准

•Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.
•Any of the following:
•Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks)
•History of response to clozapine treatment only or failure to respond to clozapine treatment
•Any of the following regarding history of schizophrenia:
•Time from initial onset of schizophrenia <2 years based on prior records or participant self-report
•Presenting with an initial diagnosis of schizophrenia
•Presenting for the first time with an acute psychotic episode requiring treatment
•Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.
•Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
•Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results
•Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.
•Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment.
•Any condition that could possibly affect drug absorption.
•Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.
•Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
•Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.

研究组 & 干预措施

CVL-231 15 mg, once daily (QD)

Experimental

Oral Dose

干预措施: Emraclidine 15 mg (Drug)

CVL-231 30 mg, once daily (QD)

Experimental

Oral Dose

干预措施: Emraclidine 30 mg (Drug)

Placebo, once daily (QD)

Placebo Comparator

Oral Dose

干预措施: Placebo (Drug)

结局指标

主要结局

Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

时间窗: Baseline through Week 6

The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. Baseline was defined as the last value obtained prior to initiation of investigational medicinal product (IMP). Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

次要结局

Change From Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S Score)(Baseline through Week 6)
Change From Baseline at All Time Points in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline; Weeks 1, 2, 3, 4, 5, and 6)
Change From Baseline at All Time Points in the Clinical Global Impression - Severity (CGI-S) Score(Baseline; Weeks 1, 2, 3, 4, 5, and 6)
Percentage of Responders at Week 6 (Responders Defined as ≥30% Reduction From Baseline in PANSS Total Score)(Baseline through Week 6)
Number of Participants With Treatment Emergent Adverse Event (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From first dose of study drug until 28 days following last dose of study drug (up to Week 10))
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECGs)(Baseline; from first dose of study drug up to Week 6)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments(Baseline; from first dose of study drug up to Week 6)
Number of Participants With Clinically Significant Changes in Vital Sign Measurements(Baseline; from first dose of study drug up to Week 6)
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results(Baseline; from first dose of study drug up to Week 6)
Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS)(Baseline; from first dose of study drug up to Week 6)
Change From Baseline in Simpson Angus Scale (SAS) Total Score(Baseline; Weeks 3 and 6)
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score(Baseline; Weeks 3 and 6)
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score(Baseline; Weeks 3 and 6)

研究者

发起方

AbbVie

申办方类型

Industry

责任方

Sponsor

研究点 (25)

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