NCT07703956尚未招募2 期
A Phase 2,Multicenter, Randomized, Double-blind, Placebo and Active Comparator Parallel-controlled Study to Evaluate the Safety and Efficacy of VV119 in Adults With Acute Schizophrenia
Vigonvita Life Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2026年7月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
研究概览
简要总结
This will be a multicenter, randomized, double-blind, placebo and active comparator parallel-controlled study designed to assess the safety and efficacy of VV119 (2.0 to 6.0 mg) for the treatment of adult participants diagnosed with DSM-5 schizophrenia who are in an acute exacerbation phase.
详细描述
Aripiprazole (20 mg) is included as a positive control to confirm the assay sensitivity of the study. The primary objective of the study is to assess the efficacy of VV119 in adult inpatients with a Diagnostic and Statistical Manual-Fifth Edition (DSM-5) diagnosis of schizophrenia. The secondary objective of the study is to assess overall safety of VV119 in adult inpatients diagnosed with DSM-5 schizophrenia.The exploratory objective is to characterize the population PK and quantify PK/PD relationship of VV119 in schizophrenia patients.
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
- •Male or female participants, 18-65 years,inclusive, at screening.
- •Body Mass Index of 18.5 to 35.0kg/m2 , and body weight no less than 50.0kg (males), body weight no less than 45.0kg (females).
- •Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI).
- •Participant is experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months before screening:a.Participans who have been recently hospitalized or who would benefit from hospitalization for an acute exacerbation or relapse of schizophrenia;b.If hospitalized at screening, the participant's current admission for acute exacerbation shall be ≤2 weeks.
- •Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening,Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items at screening:
- •Item 1 (P1; delusions) Item 2 (P2; conceptual disorganization) Item 3 (P3; hallucinatory behavior) Item 6 (P6; suspiciousness/persecution).
- •WOCBP and male participants and their partners shall use medically approved effective contraception throughout treatment and for 3 months after the final study drug dose, such as intrauterine devices, contraceptive pills, or condoms.
- •Participants who are able to understand and follow study plans and instructions; Participants who have voluntarily decided to participate in this study and signed the informed consent form.
排除标准
- •Any primary DSM-5 disorder other than schizophrenia.
- •Investigator-assessed treatment-resistant schizophrenia: participants who failed adequate sequential monotherapy with ≥2 structurally distinct, potent antipsychotics for positive symptoms,Each drug was given at ≥600 mg/day chlorpromazine equivalents for ≥6 consecutive weeks with poor efficacy.
- •Subjects with a >20% reduction in total PANSS score from screening to baseline. Reduction rate = (Screening total PANSS score - Baseline total PANSS score) / (Screening total PANSS score - 30).
- •Per investigator assessment via the Columbia-Suicide Severity Rating Scale (C-SSRS), participants with suicidal risk/intent in the 6 months before screening (answered "Yes" to C-SSRS Ideation Item 4 or 5) or any actual suicidal behavior within 12 months prior are excluded. Non-suicidal self-injury in the past year is not exclusionary, though participants with substantial current self-harm risk per clinical judgment will still be excluded.
- •Electroconvulsive therapy (ECT) within 3 months before screening.
- •Chronic clozapine use prior to screening.
- •Discontinuation of short/intermediate-acting antipsychotics or other psychoactive agents (antidepressants, mood stabilizers, antiepileptics, etc.) for less than 5 half-lives or less than 1 week at randomization.
- •Long-acting injectable antipsychotics (risperidone paliperidone palmitate, aripiprazole long-acting injectable, etc.) discontinued for less than 5 half-lives at randomization.
- •Discontinuation of QT-prolonging and torsades de pointes (TdP)-inducing medications (levofloxacin, fluconazole, ondansetron, amiodarone, metronidazole, erythromycin, haloperidol, etc.) for less than 5 half-lives at randomization.
- •Discontinuation of moderate/potent CYP3A or CYP2D6 inhibitors/inducers for less than 5 half-lives at randomization, or planned use of such agents throughout the study.
- •Prior inadequate response to aripiprazole (≥20 mg/day for minimum 6 weeks).
- •History or active epilepsy (febrile convulsions excluded).
- •History or current presence of neuroleptic malignant syndrome (NMS).
- •History or active malignancy of any type.
- •History or active ocular disease: open/closed-angle glaucoma, or acute bacterial/viral eye infection within 1 week pre-screening.
- •History or active tardive dyskinesia.
- •History of conditions/surgeries altering drug ADME or conferring safety risks (gastrectomy, gastrointestinal anastomosis, bowel resection, urinary obstruction, dysuria, etc.).
- •History of drug/food allergies, or hypersensitivity to study drug, its components, or aripiprazole analogs.
- •Pregnant or lactating female at screening/baseline.
- •History of alcohol/psychoactive substance abuse/dependence (excluding caffeine, nicotine) within 1 year pre-screening, or positive urine drug/alcohol screen at screening.
- •Clinically significant abnormal vital signs/physical exam findings at screening/baseline per investigator judgment that may interfere with study participation.
- •Orthostatic drop ≥20 mmHg systolic or ≥10 mmHg diastolic within 3 minutes of standing at screening.
- •QTcF >450 ms (male) / >470 ms (female) at screening/baseline (Fridericia formula); or other clinically significant 12-lead ECG abnormalities interfering with study participation per investigator.
- •Severe unstable medical illness (cardiac, hepatic, renal, hematologic, endocrine, neurologic, etc.) deemed ineligible by investigator.
- •Elevated ALT/AST >1.5×ULN, Cr >1.2×ULN, TBIL >1.5×ULN, or other clinically significant lab abnormalities at screening/baseline per investigator assessment.
- •Positive HBsAg, HCV-Ab, HIV-Ab or TP-Ab at screening.
- •Participation in another interventional trial with investigational product/device within 3 months pre-screening, or ongoing trial enrollment.
- •Other exclusion criteria per investigator discretion .
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
时间窗: Baseline and Week 6
The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants were rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
次要结局
- Change From Baseline in PANSS Positive Score at Week 6(Baseline and Week 6)
- Change From Baseline in PANSS Negative Score at Week 6(Baseline and Week 6)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 6(Baseline and Week 6)
- Clinical Global Impression - Improvement (CGI-I) Score at Week 6(Week 6)
- Response Rate at Week 6(Week 6)
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Score at Week 6(Baseline and Week 6)
研究者
研究点 (1)
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