NCT01006096撤回2 期
Phase II Randomized, Double-blind, Placebo-controlled, Two-arm Study to Evaluate the Safety and Efficacy of Erlotinib in the Treatment of Moderate to Severe Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA).
研究概览
简要总结
The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.
详细描述
Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinical diagnosis of moderate to severe psoriasis
- •Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI)
- •Must be able to swallow tablets
- •Must be able to provide written informed consent
- •Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization.
排除标准
- •Use of concurrent agents/therapies for psoriasis
- •Bilirubin > 3 X ≥ ULN or moderate to severe hepatic impairment
- •Pregnant or breast-feeding females
- •Subjects currently receiving other anticancer treatments
- •Subjects currently receiving other biologic treatments
- •Subjects currently receiving blood thinners (warfarin or heparin)
- •Subjects who currently smoke
- •Subjects with other skin disease which in the opinion of the investigator, would inhibit the ability to use the PGA and PASI evaluation methods
研究组 & 干预措施
Erlotinib
Experimental
干预措施: erlotinib (Drug)
Placebo tablets
Placebo Comparator
干预措施: placebo tablet (Other)
结局指标
主要结局
To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA).
时间窗: week 4, 8, 12, 16, and 24
次要结局
- To determine the rate of dose reduction or interruption as a result of adverse events.(week 4, 8, 12, 16, and 24)
- To determine quality of life using the Dermatology Life Quality Index (DLQI).(week 4, 8, 12, 16, and 24)
研究者
研究点 (1)
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