EUCTR2015-000595-10-HU进行中（未招募）1 期
A Phase 2a, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of MEDI9929 in Adult Subjects with Moderate-to-Severe Atopic Dermatitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age 18-75 years
- •- clinical diagnosis of atopic dermatitis
- •- Current disease state meeting the Hanifin and Rajka, 1980 criteria for AD
- •- Atopic dermatitis involvement of = 10% body surface area at Visit 1 assessed by EASI
- •- IGA score of = 3 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- •- EASI score of = 12 at Visit 1 (Screening) and Visit 3 (Week 0, Day 1)
- •- SCORAD of = 20 at Visit 1 (Screening)
- •- Effective birth control in line with protocol details
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- History of anaphylaxis following any biologic therapy
- •- Hepatitis B, C or HIV
- •- Pregnant or breastfeeding women
- •- History of cancer
- •- Previous receipt of biologic agents within 4 month prior to visit 3 (week 0, day 1)
研究者
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