Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Changes of molecular profiles over time
研究概览
简要总结
This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time following specific blockade of single pathophysiological factors through use of licensed biologics during routine care as systems biology challenge. To this end, ultra-deep phenotyping and prospective molecular characterization in short time-intervals and different disease equilibrium states will be carried out in targeted small sets of patients. The different layers and types of clinical and molecular information will then be integrated (integrative personal omics profiling iPOP) for generating insights into disease pathways and for extraction of molecular signatures that correspond to clinical severity scores. It will provide a good starting point for planning future trials aimed at identifying biological patterns useful for guiding targeted treatment.
详细描述
This is an exploratory study with the aim to identify molecular profiles and signatures in skin and blood that correlate with inflammatory skin disease, disease activity and disease progression, and that are associated with possible disease subtypes/endotypes. Primary target variables are differentially expressed genes (alone or in combination), secondary target variables are genetic, immunological and microbiological signatures. Influencing variables of interest include age of manifestation, disease duration, disease activity/severity, disease progression, comorbidities and therapy/treatment. Obtained biomaterial will be used for molecular profiling including DNA/RNA sequencing, ELISA, mass spectrometry, flow cytometry to identify markers and/or signatures that can correlate with individual disease courses.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent and comply with the protocol
- •Dermatologist-diagnosed chronic inflammatory skin disease
- •Subject receives systemic therapy within routine care (in-label use of biologics)
排除标准
- •Subject is unable to provide written informed consent or comply with the protocol.
- •Having used immunosuppressive/immunomodulating therapy or phototherapy within 4 weeks before the baseline visit.
- •Treatment of selected skin areas to be examined with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.
研究组 & 干预措施
Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors
Pso_Tumor Necrosis Factor (TNF) Inhibitors
干预措施: Anti-TNF (Drug)
Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors
Interleukin (IL)-12/23 Inhibitors
干预措施: Anti-IL12/23 (Drug)
Psoriasis patients receiving Interleukin (IL)-17 Inhibitors
Pso_Interleukin (IL)-17 Inhibitors
干预措施: Anti-IL17 (Drug)
Atopic dermatitis patients receiving dupilumab
Dupilumab
干预措施: Dupilumab (Drug)
Atopic dermatitis patients receiving lebrikizumab
Brodalumab
干预措施: Lebrikizumab (Drug)
Atopic dermatitis patients receiving tralokinumab
Tralokinumab
干预措施: Tralokinumab (Drug)
Atopic dermatitis patients receiving baricitinib
Baricitinib
干预措施: Baricitinib (Drug)
Atopic dermatitis patients receiving abrocitinib
Abrocitinib
干预措施: Abrocitinib (Drug)
Atopic dermatitis patients receiving upadacitinib
Upadacitinib
干预措施: Upadacitinib (Drug)
Psoriasis patients receiving Interleukin (IL)-23 Inhibitors
Interleukin (IL)-23 Inhibitors
干预措施: Anti-IL23 (Drug)
Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors
Interleukin (IL)-31 Inhibitors
干预措施: Nemolizumab (Drug)
Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors
HS_Interleukin (IL)-17 Inhibitors
干预措施: Anti-IL17 (Drug)
Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors
HS_Tumor Necrosis Factor (TNF) Inhibitors
干预措施: Anti-TNF (Drug)
结局指标
主要结局
Changes of molecular profiles over time
时间窗: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with disease severity/remission
时间窗: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatment
时间窗: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatment response
时间窗: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
次要结局
- Change in Eczema Area and Severity Index (EASI) score(Baseline and week 1, week 2, week 12, week 52)
- Change in Score of Atopic Dermatitis (SCORAD)(Baseline and week 1, week 2, week 12, week 52)
- Change in Psoriasis Area and Severity Index (PASI)(Baseline and week 1, week 2, week 12, week 52)
- Change in Hidradenitis Suppurativa Severity Score (IHS4)(Baseline and week 1, week 2, week 12, week 52)
研究者
Prof. Dr. Stephan Weidinger
Head, Inflammatory Skin Disease Center
University Hospital Schleswig-Holstein
