jRCT2080223229已完成3 期
A randomized, double-blind, placebo- and active controlled multicenter trial to demonstrate efficacy of subcutaneous secukinumab compared to placebo and etanercept (in a single-blinded arm) after twelve weeks of treatment, and to assess the safety, tolerability, and long-term efficacy in subjects from 6 to less than 18 years of age with severe chronic plaque psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized, Parallel Assignment, Double Blind Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 6age old over 至 17age old under（—）
- 性别
- All
入选标准
- •PASI score of 20 or greater at the time of randomization (Wash-out: Other systemic immunomodulating treatments: 4weeks, Phototherapy: 2weeks, Biological immunomodulating agents: 12weeks)
排除标准
- •Current forms of psoriasis other than chronic plaque-type psoriasis (for example, pustular, erythrodermic, guttate) at randomization
- •Previous use of secukinumab or any drug that targets IL-17 or IL-17 receptor
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
-
efficacy PASI 75 and IGA 0/1
次要结局
未报告次要终点
研究者
研究点 (1)
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