跳至主要内容
临床试验/NCT03358693
NCT03358693招募中不适用

Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders

Prof. Dr. Stephan Weidinger1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年1月20日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Prof. Dr. Stephan Weidinger
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. Stephan Weidinger

Head, Inflammatory Skin Disease Center

University Hospital Schleswig-Holstein

研究点 (1)

Loading locations...

相似试验