NCT05571943已完成3 期
A Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of Children, Adolescents and Adults With Mild to Moderate Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 59
- 主要终点
- The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
研究概览
简要总结
This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.
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
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are male or female ≥2 years of age at Screening (Visit 1).
- •Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
- •Subjects who have had a diagnosis of AD for at least 3 months prior to Screening .
- •Subjects who have an IGA of mild or moderate AD Severity and treatable body surface area (BSA) ≥3%at Baseline if not previously enrolled in study MEDI-MM36-301 OR b. IGA ≤ 3, with no minimum BSA and completed through Week 4/EOT Visit 6 of the study MEDI-MM36-
- •Subject is willing and able to comply with all study-related procedures, including, but not limited to, application of the study drug, and visit requirements.
排除标准
- •Subjects who have an AD flare (defined as rapid intensification of AD) within 28 days prior to Screening or Baseline (except for those previously enrolled in Study MEDI-MM36-301) or history of consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms.
- •Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD
- •Subjects with significant systemic or localized infection
- •Subjects with minimal/mild depression and suicidal ideation
- •Subjects using restricted medications, biologics and alternative therapies, or using investigational drug
研究组 & 干预措施
Difamilast Ointment 1%
Experimental
A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)
干预措施: Difamilast (Drug)
结局指标
主要结局
The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
时间窗: 52 week study period
Proportion of subjects who discontinue due to an AE over the study period
时间窗: 52-week study period
次要结局
未报告次要终点
研究者
研究点 (59)
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