NCT03013517Unknown3 期
Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 31
- 主要终点
- % of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE
研究概览
简要总结
This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2 additional years if previously on active treatment in the PEPITES study, or for 3 years if previously on placebo in the PEPITES study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed the PEPITES study.
排除标准
- •Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
- •Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.
研究组 & 干预措施
Viaskin Peanut 250µg
Experimental
干预措施: Viaskin Peanut 250µg (Drug)
结局指标
主要结局
% of subjects originating from the active arm of PEPITES reaching an Eliciting Dose (ED) ≥ 1,000 mg after 24 months of additional treatment in PEOPLE
时间窗: Month 24
次要结局
未报告次要终点
研究者
研究点 (31)
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