JPRN-jRCT2031210232已完成2 期
Phase 2a Clinical Study to evaluate efficacy and safety of JTE-451 ointment in patients with plaque psoriasis.
Miwa Yasushi0 个研究点目标入组 67 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
研究概览
简要总结
There were no stastistical significant difference in the primary endpoint between the active group and the placebo group. JTE-451 ointment was generally safe and tolerated in patients with plaque psoriasis.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 65age old（—）
- 性别
- All
入选标准
- •1. Japanese subjects who have clinical diagnosis of chronic plaque psoriasis for at least 6 months and whose disease condition is stable, at informed consent
- •2. Subjects with a PASI score >=5.0
- •3. Subjects with a PGA score of 2, 3 or 4
- •4. Subjects with BSA affected >=3% and <=20% (except for the hairy scalp)
排除标准
- •1. Subjects with psoriasis other than plaque psoriasis
- •2. Subjects who have shown no efficacy by treatment with specific biologics
- •3. Subjects with dermatologic or inflammatory condition that would affect the study assessments determined by the investigator
- •4. Subjects with acute active bacterial, fungal or viral skin infection
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