NCT00869089已完成2 期
An Open Label, Single Center Study to Assess the Safety and Efficacy of a 24 Week Treatment Course of CC-10004 in Adults With Recalcitrant Nodularis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Improvement in Prurigo Nodularis
研究概览
简要总结
This trial will include:
- Study period up to 7 months.
- Office visits monthly lasting approximately 1 hour.
- Blood Draws.
- Oral medication that is taken 2 times daily.
- Photographs and biopsies if agreed.
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
- •Must understand and voluntarily sign an informed consent form
- •Must be male or female and aged ≥ 18 years at time of consent
- •Must be able to adhere to the study visit schedule and other protocol requirements
- •Must have a diagnosis of prurigo nodularis based on clinical and histological findings and have failed four weeks of treatment with topical therapies, including corticosteroids and/or vitamin D derivatives.
- •Must meet the following laboratory criteria:
- •Hemoglobin WNL
- •Hematocrit WNL
- •White blood cell (WBC) count WNL
- •Neutrophils ≥ 1500 /dL
- •Platelets ≥ 100,000 /dL
- •Serum creatinine ≤ 1.5 mg/dL
- •Total bilirubin 2.0 mg/dL
- •Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) 1.5x upper limit of normal (ULN)
- •Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening (Visit Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.
- •Must have a negative purified protein derivative (PPD) within 28 days of the baseline visit.
排除标准
- •History of cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant by the investigator
- •Any systemic treatment (including ultraviolet light, corticosteroids, thalidomide, azathioprine, cyclosporine) within 28 days of study drug administration.
- •Any topical treatments (including corticosteroids, vitamin D derivatives) within 14 days of study drug initiation.
- •Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •Pregnant or lactating female.
研究组 & 干预措施
CC-10004
Experimental
CC-10004 treament:
30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
干预措施: CC-10004 (Drug)
结局指标
主要结局
Improvement in Prurigo Nodularis
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
Neil Korman
Principle Investigator
University Hospitals Cleveland Medical Center
研究点 (1)
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