NCT00808223已完成2 期
A Phase 2, Single-Arm Study to Evaluate the Safety and Pharmacokinetics of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis [ISN 0485-CL-0004]
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
研究概览
简要总结
To establish the safety of alefacept when administered to adolescent subjects with moderate to severe psoriasis.
详细描述
A planned interim analysis will be conducted to evaluate safety and pharmacokinetics following the Week 4 evaluation of approximately the first 12 subjects. A dose adjustment may be implemented based on these results. A preliminary review of the Week 4 pharmacokinetics of the first 6 subjects will occur to monitor exposure. If a dose adjustment is required, pharmacokinetics will be repeated for the first 12 subjects enrolled at the new dose (subjects 13-24).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has moderate to severe chronic plaque psoriasis involving at least 10% or greater body surface area
- •Subject is a candidate for systemic treatment or phototherapy
- •Subject is in good health and alefacept is not contraindicated
- •Subject must have absolute total CD4+ lymphocyte counts within the normal range at screening
- •Female subjects of child bearing potential have a negative pregnancy test prior to first dose of alefacept and agree to practice effective contraception during the study
- •Subject must have predosing laboratory findings without clinically significant abnormal values for hematocrit, hemoglobin, platelets, white blood count and differential, serum creatinine, bilirubin, ALT, AST and prothrombin.
- •Subject must have completed all standard childhood immunizations at least 12 weeks prior to the first dose
- •Subject meets medication washout requirements and agrees to follow medication restrictions during the study
- •Subject agrees to comply with the study requirements and agrees to come to the clinic for required study visits
排除标准
- •Subject has a primary dermatological diagnosis of psoriasis other than plaque psoriasis
- •Subject has a known hypersensitivity to alefacept or any excipient of the study medication
- •Subject has had a serious local infection or systemic infection within 12 weeks prior to the first dose of study drug
- •Subject has a fever (body temperature ≥ 38°C [or > 37°C for sites in Latvia]) or symptomatic viral or bacterial infection (including upper respiratory tract infection) within 1 week prior to the first dose of study drug
- •Subject is known to be positive for HIV antibodies
- •Subject has a history of chronic serious infection including hepatic disease or has positive result to serology test for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) antibody or, in Europe, tubercle bacillus (TB) at Screening
- •Subject has a history or evidence of tuberculosis based on serology or a positive PPD skin test at Screening
- •Subject has had treatment with any immunosuppressant agent within 12 weeks, any antibody or immuno-globulin within 24 weeks, or any investigational drug or approved therapy for investigational use within 8 weeks prior to the first dose of study drug
- •Subject has had more than six herpes simplex virus (HSV) breakouts per year or is currently having an outbreak or has had an outbreak within the last 24 weeks
- •Subject has a history of malignancy (other than non-melanoma skin cancers)
- •Subject has a chronic condition which is not well controlled
- •Subject is pregnant or nursing
- •Subject has a history of severe allergic or anaphylactic reactions
结局指标
主要结局
Assessment of Physical exams, vital signs, select blood chemistry and hematology, lymphocyte subset analysis, anti-alefacept antibody monitoring, adverse event monitoring including infections.
时间窗: 6 months
次要结局
- Assessment of Pharmacodynamics: Total lymphocytes and lymphocyte subsets(4 Weeks)
- Assessment of Pharmacokinetics through analysis of blood samples (only approximately first 24 subjects enrolled)(4 weeks)
研究者
研究点 (10)
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