DRKS00023872已完成4 期
An exploratory study to investigate the bioavailability andpharmacodynamics of Dupilumab in dermal interstitial fluid od atopic dermatitis
Medizinische Universität Graz, Abteilung für Endokrinologie und Diabetologie0 个研究点目标入组 10 人开始时间: 2020年12月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Key inclusion criteria:
- •- Male and female atopic dermatitis patients 18 – 65 years of age
- •- Patients diagnosed for at least 6 months before enrollment, with moderate-to-severe atopic dermatitis (AD) (EASI >16; IGA =3, as specified below and not adequately controlled by topical medication(s)
- •- At least one suitable lesion, which is well accessible for OFM investigation.
排除标准
- •Key exclusion criteria
- •- Pregnant and breast feeding women and women of child-bearing potential unwilling to use effective contraception during the study
- •- History of or ongoing, chronic or recurrent infectious disease, or known tuberculosis infection as orally stated by the subject; History of Hepatitis B or C or HIV, tested via serum
- •- Planned administration of live vaccines during the study period or 6 weeks prior to enrolment
- •- Any other active dermatoses in need of systemic treatment
- •- Ongoing use of concomitant AD treatments (e.g., topical or systemic corticosteroids, UV therapy). Washout periods detailed in the protocol have to be adhered to Investigational and reference therapy
- •- Further: Excessive sun exposure, uncontrolled systemic disease and ongoing infections
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