RecruitingNCT03358693

Molecular Signatures in Inflammatory Skin Disease

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


Sponsor

Prof. Dr. Stephan Weidinger

Enrollment

300 participants

Start Date

Jan 20, 2017

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • 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 Criteria3

  • 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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Interventions

DRUGAnti-TNF

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

DRUGAnti-IL12/23

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

DRUGAnti-IL17

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

DRUGDupilumab

Subject receives Dupilumab open-label as per guidelines

DRUGAnti-IL23

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

DRUGBaricitinib

Subject receives Baricitinib open-label as per guidelines

DRUGAbrocitinib

Subject receives Abrocitinib open-label as per guidelines

DRUGUpadacitinib

Subject receives Upadacitinib open-label as per guidelines

DRUGTralokinumab

Subject receives Tralokinumab open-label as per guidelines

DRUGLebrikizumab

Subject receives Lebrikizumab open-label as per guidelines

DRUGNemolizumab

Subject receives Nemolizumab open-label as per guidelines


Locations(1)

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, Germany

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NCT03358693


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