NCT03780166撤回2 期
A Phase 2 Dose-Escalation Study of the Safety and Tolerability of INCB050465 in Participants With Pemphigus Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of parsaclisib in participants with mild to moderate pemphigus vulgaris.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically documented and confirmed diagnosis of pemphigus vulgaris: minimum of 6 months of pemphigus vulgaris diagnosis; positive for anti-desmoglein (DSG)1 or DSG3; Pemphigus Disease Area Index score of 8 to 45 points; active skin, scalp, or mucosal lesions.
- •Disease progression after treatment with standard therapies that are known to confer clinical benefit, or intolerant to treatment; there is no limit to the number of prior treatment regimens.
- •Willingness to avoid pregnancy or fathering children.
- •If required, willing to receive Pneumocystis jirovecii pneumonia prophylaxis during the study period.
排除标准
- •Pregnant or breast-feeding female.
- •Participants with pemphigus vulgaris who are treatment-naive.
- •Use of protocol-specified medications within defined periods before baseline.
- •Evidence or history of clinically significant infection or protocol-defined medical conditions
- •Laboratory values outside the protocol-defined range at screening.
- •Known or suspected allergy to parsaclisib or any component of the study drug.
- •Known history of clinically significant drug or alcohol abuse in the last year before baseline.
- •Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
- •Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
研究组 & 干预措施
Parsaclisib
Experimental
干预措施: Parsaclisib (Drug)
结局指标
主要结局
Number of treatment-emergent adverse events
时间窗: Up to 20 weeks
Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
次要结局
- Cmax of Parsaclisib(Up to 6 weeks)
- tmax of Parsaclisib(Up to 6 weeks)
- AUC0-t of Parsaclisib(Up to 6 weeks)
- CL/F of Parsaclisib(Up to 6 weeks)
- Cmin of Parsaclisib(Up to 6 weeks)
研究者
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