NCT00162253终止2 期
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of BMS-587101 in Patients With Moderate to Severe Psoriasis
Bristol-Myers Squibb16 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年4月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- To estimate the clinical response in terms of the percent of subjects achieving PASI_50 in each treatment arm, and to determine whether there was a difference in PASI_50 between each BMS-587101 treatment arm and placebo
研究概览
简要总结
The purpose of this clinical research study is to learn if BMS-587101 is effective on the treatment of Moderate to Severe Psoriasis. The safety of this treatment will also be studied.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Otherwise healthy individuals with a diagnosis of plaque-type psoriasis at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may be enrolled).
- •Men and Women Not of Child Bearing Potential (i.e. women who are postmenopausal or surgically sterile), women ages 18 to
排除标准
- •Women of Child Bearing Potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study.
- •Known or suspected infection, including infection with human immunodeficiency virus (HIV), hepatitis B or C viruses. Any recent infections requiring antibiotic treatment that completed within 4 weeks of enrollment.
- •Any known malignancy or history of malignancy within 5 years prior to enrollment, with the exception of basal cell or squamous cell carcinoma of the skin that has been excised with no evidence of recurrence (squamous cell carcinoma of other locations is exclusionary).
- •Any history of Guillane-Barre syndrome. History of keloid formation.
结局指标
主要结局
To estimate the clinical response in terms of the percent of subjects achieving PASI_50 in each treatment arm, and to determine whether there was a difference in PASI_50 between each BMS-587101 treatment arm and placebo
次要结局
- To estimate the proportion of patients achieving a PASI 75 response in each treatment arm.
- To estimate the percent change (or reduction) in PASI score at 12 weeks of treatment in each treatment arm.
- To estimate the proportion of patients achieving a PGA score of clear to minimal in each treatment arm.
- To estimate the percent change from baseline in epidermal thickness of psoriatic lesion.
- To evaluate the safety and tolerability of BMS-587101 in patients with psoriasis.
- To evaluate the single- and multiple-dose pharmacokinetics of BMS-587101
研究者
研究点 (16)
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