Molecular Signatures in Inflammatory Skin Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Anti-TNF: Subject receives anti-TNF antibodies open-label as per guidelines

Anti-IL12/23: Subject receives anti-IL12/23 antibodies open-label as per guidelines

Anti-IL17: Subject receives anti-IL17 antibodies open-label as per guidelines

Dupilumab: Subject receives Dupilumab open-label as per guidelines

Anti-IL23: Subject receives anti-IL23 antibodies open-label as per guidelines

Baricitinib: Subject receives Baricitinib open-label as per guidelines

Abrocitinib: Subject receives Abrocitinib open-label as per guidelines

Upadacitinib: Subject receives Upadacitinib open-label as per guidelines

Tralokinumab: Subject receives Tralokinumab open-label as per guidelines

Lebrikizumab: Subject receives Lebrikizumab open-label as per guidelines

Nemolizumab: Subject receives Nemolizumab open-label as per guidelines

Study summary

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.

Eligibility

Primary outcome measure(s)

• Changes of molecular profiles over time — 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 — 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 — 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 — Baseline and week 2, week 4, week 12, week 52
  Changes of immune cell composition, transcriptome, proteome and microbiome signatures

Trial sites (1)

On this site

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