An observational study in Atopic Dermatitis and Psoriasis, sponsored by Prof. Dr. Stephan Weidinger. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Prof. Dr. Stephan Weidinger · Observational
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.
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.
Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care
Exclusion Criteria:
Pso\_Tumor Necrosis Factor (TNF) Inhibitors
Drug: Anti-TNF
Interleukin (IL)-12/23 Inhibitors
Drug: Anti-IL12/23
Pso\_Interleukin (IL)-17 Inhibitors
Drug: Anti-IL17
Dupilumab
Drug: Dupilumab
Brodalumab
Drug: Lebrikizumab
Tralokinumab
Drug: Tralokinumab
Baricitinib
Drug: Baricitinib
Abrocitinib
Drug: Abrocitinib
Upadacitinib
Drug: Upadacitinib
Interleukin (IL)-23 Inhibitors
Drug: Anti-IL23
Interleukin (IL)-31 Inhibitors
Drug: Nemolizumab
HS\_Interleukin (IL)-17 Inhibitors
Drug: Anti-IL17
HS\_Tumor Necrosis Factor (TNF) Inhibitors
Drug: Anti-TNF
Subject receives anti-TNF antibodies open-label as per guidelines
Subject receives anti-IL12/23 antibodies open-label as per guidelines
Subject receives anti-IL17 antibodies open-label as per guidelines
Subject receives Dupilumab open-label as per guidelines
Subject receives anti-IL23 antibodies open-label as per guidelines
Subject receives Baricitinib open-label as per guidelines
Subject receives Abrocitinib open-label as per guidelines
Subject receives Upadacitinib open-label as per guidelines
Subject receives Tralokinumab open-label as per guidelines
Subject receives Lebrikizumab open-label as per guidelines
Subject receives Nemolizumab open-label as per guidelines
Changes of molecular profiles over time
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with disease severity/remission
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with treatment
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with treatment response
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Change in Eczema Area and Severity Index (EASI) score
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Change in Score of Atopic Dermatitis (SCORAD)
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Change in Psoriasis Area and Severity Index (PASI)
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Change in Hidradenitis Suppurativa Severity Score (IHS4)
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Plan to share: No
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Prof. Dr. Stephan Weidinger