NCT07467993招募中2 期
A Phase 2a, Randomized, Participant- and Investigator- Blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With DSM-5 Schizophrenia (STAR-1)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 16
- 主要终点
- Change from baseline in Positive and Negative Symptom Scale (PANSS) total score
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety, and tolerability of GXV813 in the treatment of an acute episode of 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 is aged 18 to 65 years, inclusive, at screening
- •Participant is capable of providing informed consent
- •Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)
- •Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
- •Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
- •The participant requires hospitalization for this acute exacerbation or relapse of symptoms
- •If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening
- •Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:
- •i. Item 1 (P1; delusions)
- •ii. Item 2 (P2; conceptual disorganization)
- •iii. Item 3 (P3; hallucinatory behavior)
- •iv. Item 6 (P6; suspiciousness/persecution)
排除标准
- •Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) at screening)
- •History of treatment resistance to antipsychotic medications defined as inadequate response to two adequate courses of pharmacotherapy or previous clozapine treatment for treatment-resistant schizophrenia
- •Participants who need to be treated with drugs that are known to be moderate and strong CYP3A4 inhibitors and inducers will be excluded
- •Participants taking a long-acting injectable antipsychotic could not have received a dose of medication in the last 12 weeks (24 weeks for INVEGA TRINZA®) before baseline
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
GXV813
Experimental
GXV813 administered orally.
干预措施: GXV813 (Drug)
Placebo
Placebo Comparator
Placebo administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Positive and Negative Symptom Scale (PANSS) total score
时间窗: Baseline, Week 6
PANSS is a 30-item rating scale used to assess the positive, negative, and general psychopathy symptoms of schizophrenia. PANSS total score ranges from 30 to 120 , where a higher score indicates greater severity.
次要结局
- Number of participants with AEs(Baseline to 6 weeks)
- Participant clinically significant response(Baseline, week 6)
- Change from baseline in PANSS positive sub-score(Baseline, week 6)
- Change from baseline in PANSS negative sub-score(Baseline, week 6)
- Change from baseline in Marder negative factor score(Baseline, week 6)
- Change from baseline in Clinical Global Impression- Severity (CGI-S) scale(Baseline up to week 6)
- Assess the pharmacokinetics (PK) of GXV813: concentration-time curve (AUC)(Up to 6 weeks)
- Assess the pharmacokinetics (PK) of GXV813: maximum observed plasma concentration (Cmax)(Up to 6 weeks)
研究者
研究点 (16)
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