NCT00306878已完成1 期
Phase I Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 45 人开始时间: 1995年8月最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer
研究概览
简要总结
The purpose of this clinical research study is to determine the safety, pharmacokinetics, immunogenicity in humans, the recovery time required from the biologic effects and the optimal biologic dose range of BMS188667 (CTLA4Ig)
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women who received adequate counseling and were judged reliabel in their use of contraceptive measures.
- •Diagnosis and documentation of stable psoriasis vulgaris of at least 6 months duration.
- •Psoriasis vulgaris total body surface area involvement between 10% and 49% (Overall Disease Severity Score [ODSS]of 4-7 inclusive).
- •Failure of toxicity or inefficacy of at least one standard antipsoriatic therapy including topical treatment, etretinate, phototherapy, or methotrexate.
排除标准
- •Treatment with: a) Retinoids within 2 years, b) cyclosporin A, systemic corticosteroids, methotrexate, or an investigational agent within 16 weeks, c) any phototherapy or photochemotherapy within 4 weeks d) any topical psoriasis treatment other than emollients within 2 weeks prior to enrollment.
- •No clinical response to a prior adequate therapeutic trial of cyclosporin A
- •Prolonged exposure to the sun within 4 weeks prior to the first dose.
- •Guttate, erythrodermic, or pustular psoriasis.
- •Spontaneously improving or rapidly deteriorating psoriasis vulgaris.
结局指标
主要结局
Change relative to pretreatment of the Overall Disease Severity Score (ODSS) for psoriasis vulgaris as assess by a blinded observer. Phage-Neutralizing anitbody titer
时间窗: at Day 43
次要结局
- Physician's globas Assessment(at Day 36)
- Mean percentage of anti-bacteriophage FX174 antibody of IgG isotype in sera collected(at Day 43)
- Phage-neutralizing antibody titer(at Day 16 and Day 29)
研究者
研究点 (5)
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