NL-OMON48187已完成2 期
Multi-center, double-blind, randomised, placebo-controlled, phase IIb dose-finding study to evaluate efficacy and safety of different subcutaneous doses of BI 655130 in patients with moderate to severe Palmoplantar Pustulosis (PPP) - 1368-0016
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Male or female patients, 18 to 75 years of legal age (according to local
- •legislation) at screening (visit 1)
- •* Diagnosed with Palmoplantar Pustulosis with a minimum PPP ASI score of 12 and
- •PPP PGA of at least moderate severity (*3), both at screening (visit 1) and
- •baseline (visit 2)
- •* Presence of white or yellow pustules on palms and/or soles at screening
- •(visit 1) and baseline (visit 2)
- •* Pustular severity score *2 in at least one region and *10 well-demarcated
- •pustules (white or yellow pustules) across all regions at screening (visit 1)
- •and baseline (visit 2)
排除标准
- •* Patients with a reduction in PPP ASI total score * 5 from screening (Visit 1)
- •to baseline (Visit 2) are excluded
- •* Patients with plaque psoriasis with worsening of plaque psoriasis within the
- •last 3 months prior to screening.
研究者
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