NCT07680946招募中2 期
Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
研究概览
简要总结
The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of schizophrenia.
- •Treatment-resistant.
- •Requires antipsychotic treatment and is currently receiving "standard of care".
- •PANSS total score between 80 and 120, inclusive at screening and baseline.
排除标准
- •Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia.
- •Ongoing clozapine treatment.
- •Risk for suicidal behavior.
- •Any severe or uncontrolled medical condition that could affect the participant's ability to participate.
- •Note: Other protocol-specified Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Ublituximab
Experimental
Participants will receive ublituximab intravenous (IV) infusion.
干预措施: Ublituximab (Drug)
结局指标
主要结局
Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score
时间窗: At Week 12
次要结局
- Change From Baseline in PANSS Total Score(Baseline, Week 12, 24, and 48)
- Change From Baseline in Clinical Global Impressions - Improvement (CGI-I)(Baseline, Week 12, 24, 48)
- Change From Baseline in 4-Item Negative Symptom Assessment (NSA-4)(Baseline, Week 12, 24, and 48)
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to Week 48)
研究者
研究点 (2)
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