Topical INCB018424 Lichen Planus

赞助:

合作者:

信息的提供 (责任方):

Aaron R. Mangold，Mayo Clinic

追踪信息

首次提交日期 ^ICMJE

October 3, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

August 30, 2018

预计主要完成日期

November 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

modified CAILS[ Time Frame: week 0 to week 4 ]

lesion count[ Time Frame: week 0 to week 4 ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Pruritus NRS[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
Skindex-16[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
Physician Global Assessment[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
Body Surface Area[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
modified CAILS[ Time Frame: week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
lesion count[ Time Frame: week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]

描述性信息

简略标题 ^ICMJE

Topical INCB018424 Lichen Planus

正式标题 ^ICMJE

INCB018424 in the Treatment of Cutaneous Lichen Planus

简要概况

To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 2

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述: Topical INCB018424
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: INCB018424
Topical cream

研究工具

Experimental: INCB018424
INCB018424 Cream

招募信息

招募状态 ^ICMJE

Active, not recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

July 2020

预计主要完成日期

November 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation Both men and women must be at least 18 years of age at the time of screening Subjects must have clinical and histological features of LP LP must involve between 2 and 20% of the BSA Subjects must have a minimum of 10 lesions of LP Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Aaron R. Mangold，Mayo Clinic

研究赞助商 ^ICMJE

Aaron R. Mangold

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Aaron R Mangold Mayo Clinic

PRS 账户

Mayo Clinic

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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