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NCT Number: NCT03358693

Molecular Signatures in Inflammatory Skin Disease

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, 24105, Germany

Location status: Recruiting

Location contact

Sascha Gerdes, MD

CONTACT

Stephan Weidinger, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-TNF

Drug

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

Anti-IL12/23

Drug

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

Anti-IL17

Drug

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

Dupilumab

Drug

Subject receives Dupilumab open-label as per guidelines

Anti-IL23

Drug

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

Baricitinib

Drug

Subject receives Baricitinib open-label as per guidelines

Abrocitinib

Drug

Subject receives Abrocitinib open-label as per guidelines

Upadacitinib

Drug

Subject receives Upadacitinib open-label as per guidelines

Tralokinumab

Drug

Subject receives Tralokinumab open-label as per guidelines

Lebrikizumab

Drug

Subject receives Lebrikizumab open-label as per guidelines

Nemolizumab

Drug

Subject receives Nemolizumab open-label as per guidelines

Primary outcomes

  1. Changes of molecular profiles over time

    Time frame: Baseline and week 2, week 4, week 12, week 52

    Changes of immune cell composition, transcriptome, proteome and microbiome signatures

  2. Changes of molecular profiles associated with disease severity/remission

    Time frame: Baseline and week 2, week 4, week 12, week 52

    Changes of immune cell composition, transcriptome, proteome and microbiome signatures

  3. Changes of molecular profiles associated with treatment

    Time frame: Baseline and week 2, week 4, week 12, week 52

    Changes of immune cell composition, transcriptome, proteome and microbiome signatures

  4. Changes of molecular profiles associated with treatment response

    Time frame: Baseline and week 2, week 4, week 12, week 52

    Changes of immune cell composition, transcriptome, proteome and microbiome signatures

Secondary outcomes

  1. Change in Eczema Area and Severity Index (EASI) score

    Time frame: Baseline and week 1, week 2, week 12, week 52

    Clinical severity score

  2. Change in Score of Atopic Dermatitis (SCORAD)

    Time frame: Baseline and week 1, week 2, week 12, week 52

    Clinical severity score

  3. Change in Psoriasis Area and Severity Index (PASI)

    Time frame: Baseline and week 1, week 2, week 12, week 52

    Clinical severity score

  4. Change in Hidradenitis Suppurativa Severity Score (IHS4)

    Time frame: Baseline and week 1, week 2, week 12, week 52

    Clinical severity score

Study contacts

Contact information is provided by the study sponsor or research team.

Sascha Gerdes, MD

CONTACT

[email protected]

004943150021101

Stephan Weidinger, MD

CONTACT

[email protected]

004943150021101

Sponsors and collaborators

Lead sponsor

Prof. Dr. Stephan Weidinger

Other

Registry information

Official study title

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

Acronym: MSID

Important dates

Study start
2017
Primary completion
2028
Study completion
2029
First posted
Nov 30, 2017
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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