Atopic Dermatitis, Psoriasis
Conditions
Brief 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.
Detailed description
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.
Interventions
Subject receives Nemolizumab open-label as per guidelines
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
Sponsors
Study design
Eligibility
Inclusion criteria
* 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)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 over time | Baseline and week 2, week 4, week 12, week 52 | Changes of immune cell composition, transcriptome, proteome and microbiome signatures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Eczema Area and Severity Index (EASI) score | Baseline and week 1, week 2, week 12, week 52 | Clinical severity score |
| Change in Score of Atopic Dermatitis (SCORAD) | Baseline and week 1, week 2, week 12, week 52 | Clinical severity score |
| Change in Psoriasis Area and Severity Index (PASI) | Baseline and week 1, week 2, week 12, week 52 | Clinical severity score |
| Change in Hidradenitis Suppurativa Severity Score (IHS4) | Baseline and week 1, week 2, week 12, week 52 | Clinical severity score |
Countries
Germany