NCT05378698终止2 期
Effects of Tralokinumab in the Skin: an Immunologic and Molecular Investigation (TRALIS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Concentration of Tralokinumab in lesional skin after 16 weeks of treatment
研究概览
简要总结
The clinical efficacy of tralokinumab has been demonstrated in the treatment of AD; its MOA however remains insufficiently understood. A better understanding of the mechanisms underlying the clinical effects of tralokinumab would be of great clinical benefit since it may ultimately help us to identify more precisely candidate patients who may benefit from a therapy with tralokinumab.
详细描述
Primary objective:
To detect and quantify Tralokinumab in the skin of treated AD patients and concurrently characterize the cellular and molecular changes of the cutaneous and systemic immune response
Secondary objectives:
- Clinical response analysed by SCORAD, IG, DLQI and worst daily pruritus NRS
- To identify immunologic changes on a cellular and molecular level in the skin and in the blood in correlation with Tralokinumab levels over the treatment course.
- Changes in the skin barrier function over the treatment course
Primary outcome:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria (patients):
- •Moderate to severe AD
- •EASI < 50
- •18-65 years old
- •Subject is capable of giving informed consent
- •Signed informed consent
- •Inclusion criteria (Healthy controls):
- •No diagnosis or history of atopic dermatitis
- •18-65 years old
- •Subject is capable of giving informed consent
- •Signed informed consent
排除标准
- •Use of systemic corticosteroids or systemic immunosuppressive/immunomodulating drugs within four weeks prior to start of the study
- •Use of tanning beds or phototherapy within 6 weeks prior to start of the study
- •History of cancer except for treated basal cell or spinal cell carcinoma of the skin
- •Active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
- •Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Previous enrolment into the current study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
研究组 & 干预措施
Tralokinumab
Active Comparator
Patients with AD
干预措施: Application of Tralokinumab (Drug)
Healthy arm
No Intervention
Healthy controls
结局指标
主要结局
Concentration of Tralokinumab in lesional skin after 16 weeks of treatment
时间窗: 2 years
Concentration of Tralokinumab in lesional skin after 16 weeks of treatment in comparison to the begin of the study assessed by mass spectrometry with Parallel Reaction Monitoring (PRM) using the Orbitrap ECLIPSE mass spectrometer
次要结局
- Clinical outcome analysed by SCORAD(2 years)
- Immunologic changes on a cellular level in the skin(2.5 years)
- Detection and quantification of Tralokinumab levels in skin swabs(2 years)
- Levels of IL-13 in skin biopsies(2.5 years)
- Levels of total serum IgE(2 years)
- Clinical outcome analysed by IGA(2 years)
- Immunologic changes on a molecular level in the skin(2.5 years)
- Immunologic changes on a cellular and molecular level in the blood(2.5 years)
- Immunologic changes on a molecular level in the blood(2.5 years)
- Changes in skin impendance asessed by NeviSense(2.5 years)
- Clinical outcome analysed by DLQI(2 years)
- Clinical outcome analysed by worst daily pruritus NRS(2 years)
- Detection and quantification of Tralokinumab levels in skin biopsies(2 years)
- Levels of IL-13 in blood serum(2.5 years)
- Blood eosinophil counts(2 years)
研究者
研究点 (1)
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