Pattern Recognition of Immune Cells in Atopic Dermatitis Patients Receiving Dupilumab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Comparison of T-cell inflammatory markers
研究概览
简要总结
Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy.
The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.
详细描述
A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.
The PRI is a new bioinformatic analysis strategy that allows in-depth data analysis from flow cytometry with multiple variables. This facilitates the identification of meaningful T cell subpopulations, which are differentially abundant between two groups to predict responders and non-responders prior to dupilumab treatment.
Peripheral blood will be collected before, 4 weeks, 8 weeks, and 16 weeks after initiating the systemic treatment with dupilumab to identify recognition patterns/markers on the T cells. Therefore, a predefined multicolor flow cytometry panel was developed to analyse lineage, differentiation and activation markers.
Patients will receive a systemic therapy (dupilumab 600 mg loading dose, followed by 300 mg in two weeks intervals). Follow up visits will be performed every 3 months starting from the second visit (2nd visit will take place 4 weeks after initiating Dupilumab treatment).
The blood samples that are taken as part of this scientific study are pseudonymized in the research laboratories and stored for a period of 5 years after the end of this study or the publication of the results and destroyed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and above
- •Diagnosis of atopic dermatitis for ≥1 year
- •Inadequate response to treatment with topical medications
- •Confirmed dupilumab treatment
排除标准
- •Age below 18
- •Known or suspected allergy or reaction to any component of the dupilumab formulation
- •Known active allergic or irritant contact dermatitis that is likely to interfere with the assessment of the severity of AD
- •Severe conjunctivitis or blepharitis
结局指标
主要结局
Comparison of T-cell inflammatory markers
时间窗: 1 year
Identification of at least one pattern recognition profile showing a strong association with responder status to dupilumab therapy
次要结局
- Different T-cell pattern with dupilumab therapy(1.5 years)
- Assign recognition patterns to clinical symptoms(3 months)
- Connection of molecular profile and phenotype(3 months)
研究者
Margitta Worm
Prof. Dr. med. Margitta Worm
Charite University, Berlin, Germany