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Recruiting NCT03358693

Molecular Signatures in Inflammatory Skin Disease

— Observational Atopic Dermatitis Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anti-TNF, Anti-IL12/23, Anti-IL17, Dupilumab.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Psoriasis. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Anti-TNF
    Subject receives anti-TNF antibodies open-label as per guidelines
  • Drug Anti-IL12/23
    Subject receives anti-IL12/23 antibodies open-label as per guidelines
  • Drug Anti-IL17
    Subject receives anti-IL17 antibodies open-label as per guidelines
  • Drug Dupilumab
    Subject receives Dupilumab open-label as per guidelines
  • Drug Anti-IL23
    Subject receives anti-IL23 antibodies open-label as per guidelines
  • Drug Baricitinib
    Subject receives Baricitinib open-label as per guidelines
  • Drug Abrocitinib
    Subject receives Abrocitinib open-label as per guidelines
  • Drug Upadacitinib
    Subject receives Upadacitinib open-label as per guidelines
  • Drug Tralokinumab
    Subject receives Tralokinumab open-label as per guidelines
  • Drug Lebrikizumab
    Subject receives Lebrikizumab open-label as per guidelines

Primary outcome measures

  • Changes of molecular profiles over time [Time frame: Baseline and week 2, week 4, week 12, week 52]
  • Changes of molecular profiles associated with disease severity/remission [Time frame: Baseline and week 2, week 4, week 12, week 52]
  • Changes of molecular profiles associated with treatment [Time frame: Baseline and week 2, week 4, week 12, week 52]
  • Changes of molecular profiles associated with treatment response [Time frame: Baseline and week 2, week 4, week 12, week 52]
Secondary outcome measures (4)
  • Change in Eczema Area and Severity Index (EASI) score [Time frame: Baseline and week 1, week 2, week 12, week 52]
  • Change in Score of Atopic Dermatitis (SCORAD) [Time frame: Baseline and week 1, week 2, week 12, week 52]
  • Change in Psoriasis Area and Severity Index (PASI) [Time frame: Baseline and week 1, week 2, week 12, week 52]
  • Change in Hidradenitis Suppurativa Severity Score (IHS4) [Time frame: Baseline and week 1, week 2, week 12, week 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Germany · 1 center
  • Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel — Kiel

Identifiers

NCT: NCT03358693 · A100/12 · A100/12_A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗