Molecular Signatures in Inflammatory Skin Disease (MSID)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2028
  • participants needed
    300
  • sponsor
    Prof. Dr. Stephan Weidinger
Updated on 4 October 2022
skin disorder
psoriasis
systemic therapy
secukinumab
ustekinumab
infliximab
atopy
dermatitis
inflammatory dermatosis
dupilumab
upadacitinib
tralokinumab
baricitinib
brodalumab
ixekizumab

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.

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.

Details
Condition Atopic Dermatitis, Psoriasis
Treatment Infliximab, Secukinumab, Ixekizumab, ustekinumab, Dupilumab, Baricitinib, Tralokinumab, Upadacitinib, Brodalumab, Abrocitinib
Clinical Study IdentifierNCT03358693
SponsorProf. Dr. Stephan Weidinger
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Ability to provide written informed consent and comply with the protocol
Diagnosis of chronic psoriasis or atopic dermatitis
PASI score ≥ 10 or EASI score ≥ 16
Investigator Global Assessment (IGA) ≥ 3
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
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