EUCTR2010-019689-10-GR进行中（未招募）不适用
A multi-center, double-blind, placebo-controlled, proof-of-concept study to evaluate the efficacy and tolerability of KRP203 in patients with active subacute cutaneous lupus erythematosus - A2202
ovartis Services AG0 个研究点目标入组 24 人开始时间: 2011年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male and female (non-pregnant, non-lactating female)patients between 18-65 years of age. Having SCLE as described by Sontheimer et al (see Section 6.2) for at least 3 months before screening.
- •- Moderate to severe active skin disease at baseline by having an activity score of CLASI ³ 6, has to be demontrated, with at least 2 points in at least 3 different anatomical locations for erythema or scale/hypertrophy.
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren`s syndrome are allowed to enter the study
- •- Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.
- •Other protocol-defined exclusion criteria may apply.
研究者
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