NCT03540160终止3 期
An Open-Label Long-Term Safety Study of Serlopitant for the Treatment of Pruritus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 558
- 试验地点
- 85
- 主要终点
- Number of Subjects With Treatment-emergent Adverse Events
研究概览
简要总结
Study of the long term safety of serlopitant for the treatment of pruritus in adults.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age 18 years or older at consent.
- •Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.
- •Female subjects of childbearing potential must be willing to practice highly effective contraception until 5 weeks after last dose of study drug.
- •Willing and able to comply with study visits and study related requirements including providing written informed consent.
排除标准
- •Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous malignancies).
- •Any known major psychiatric diagnosis, such as major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder, which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to enrollment.
- •Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease, or history of thyroid malignancy; or the prescense of any medical condition or disability, that could interfere with the assessment of safety in this study or compromise the safety of the subject.
- •Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever is longer) or expected participation in another clinical study involving an investigational product or device during the subject's participation in this study.
- •Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant, fosaprepitant, rolapitant) within 4 weeks.
- •Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.
- •Currently pregnant or breastfeeding or planning to become pregnant during the study.
研究组 & 干预措施
Experimental: 5 mg Serlopitant Tablets
Experimental
Serlopitant Tablets
干预措施: 5 mg Serlopitant Tablets (Drug)
结局指标
主要结局
Number of Subjects With Treatment-emergent Adverse Events
时间窗: From baseline until the Follow-up (F/U) visit which occurred 35 days (+ 7 days) after the Week 52 visit or the last dose of study drug for subjects who discontinued study drug early.
Treatments emergent adverse events (TEAEs) and serious adverse events (SAEs) were recorded from the first study drug administration through the follow-up visit. Severity of all AEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03. During the period between informed consent and first study drug dose, only SAEs caused by a protocol-mandated intervention were collected.
次要结局
未报告次要终点
研究者
研究点 (85)
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