NCT00673556已完成3 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study Examining the Efficacy and Safety of Weekly Intramuscular Administration of 15mg Alefacept Over 12 Weeks in a Population of Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 195
- 主要终点
- Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
研究概览
简要总结
To assess the efficacy and safety of Alefacept compared to placebo for the treatment of Chronic Plaque Psoriasis in patients for whom conventional therapies are ineffective and inappropriate
详细描述
Patients who completed the initial 24-week treatment course (12 weeks of weekly dosing following b y 12 weeks of follow-up) and met the eligibility criteria continued in the 24-week open label extension
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Chronic Plaque Psoriasis involving ≥ 10% body surface area
- •Treatment history for Psoriasis in which 3 or more conventional anti-psoriatic therapies are inappropriate or ineffective
- •CD4+ T lymphocyte counts at or above the lower limit of normal
排除标准
- •Clinically significant abnormal hematology values or blood chemistry values
- •AST or ALT ≥ 3x the upper limit of normal
- •Other types of Psoriasis
- •Serious infection within the 3 months prior to the first dose of study drug
- •History of drug or alcohol abuse within the past 2 years
- •Antibody positive for HIV
- •History of malignancy
- •History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease
- •Exposure to psoriasis-modifying phototherapy or high-potency topical corticosteroid therapy within 2 weeks prior to the first dose of study drug
- •Exposure to systemic anti-psoriatic therapy , topical immunomodulators or topical CNIs within 4 weeks prior to the first dose of study drug
- •Current treatment with any therapy for tuberculosis
- •Previous exposure to Alefacept
- •Nursing mothers, pregnant women, and women planning to become pregnant during the study
研究组 & 干预措施
Course A2
Placebo Comparator
干预措施: placebo (Drug)
Course A1
Experimental
干预措施: alefacept (Drug)
Course B
Experimental
Open label extension
干预措施: alefacept (Drug)
结局指标
主要结局
Proportion of patients achieving a Psoriasis Area and Severity Index (PASI) score of ≥ 50
时间窗: 14 Weeks
次要结局
- Proportion of patients achieving a PASI score of ≥ 50 any time during study(Throughout study)
- Proportion of patients achieving a PASI score of ≥ 75(14 Weeks)
研究者
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