Molecular Signatures in Inflammatory Skin Disease (MSID)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Drug: Dupilumab; Drug: Tralokinumab; Drug: Baricitinib; Drug: Abrocitinib; Drug: Upadacitinib; Drug: Anti-TNF; Drug: Anti-IL12/23; Drug: Anti-IL17; Drug: Lebrikizumab; Drug: Anti-IL23; Drug: Nemolizumab

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Stephan Weidinger, MD; Phone Number: 004943150021101; Email: sweidinger@dermatology.uni-kiel.de
• Study Contact Backup: Name: Sascha Gerdes, MD; Phone Number: 004943150021101; Email: sgerdes@dermatology.uni-kiel.de

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Recruiting
    • Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
    • Contact: Stephan Weidinger, MD
    • Contact: Sascha Gerdes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atopic dermatitis patients receiving dupilumab; Dupilumab	Drug: Dupilumab; Subject receives Dupilumab open-label as per guidelines
Atopic dermatitis patients receiving tralokinumab; Tralokinumab	Drug: Tralokinumab; Subject receives Tralokinumab open-label as per guidelines
Atopic dermatitis patients receiving baricitinib; Baricitinib	Drug: Baricitinib; Subject receives Baricitinib open-label as per guidelines
Atopic dermatitis patients receiving abrocitinib; Abrocitinib	Drug: Abrocitinib; Subject receives Abrocitinib open-label as per guidelines
Atopic dermatitis patients receiving upadacitinib; Upadacitinib	Drug: Upadacitinib; Subject receives Upadacitinib open-label as per guidelines
Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors; Pso_Tumor Necrosis Factor (TNF) Inhibitors	Drug: Anti-TNF; Subject receives anti-TNF antibodies open-label as per guidelines
Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors; Interleukin (IL)-12/23 Inhibitors	Drug: Anti-IL12/23; Subject receives anti-IL12/23 antibodies open-label as per guidelines
Psoriasis patients receiving Interleukin (IL)-17 Inhibitors; Pso_Interleukin (IL)-17 Inhibitors	Drug: Anti-IL17; Subject receives anti-IL17 antibodies open-label as per guidelines
Atopic dermatitis patients receiving lebrikizumab; Brodalumab	Drug: Lebrikizumab; Subject receives Lebrikizumab open-label as per guidelines
Psoriasis patients receiving Interleukin (IL)-23 Inhibitors; Interleukin (IL)-23 Inhibitors	Drug: Anti-IL23; Subject receives anti-IL23 antibodies open-label as per guidelines
Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors; Interleukin (IL)-31 Inhibitors	Drug: Nemolizumab; Subject receives Nemolizumab open-label as per guidelines
Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors; HS_Interleukin (IL)-17 Inhibitors	Drug: Anti-IL17; Subject receives anti-IL17 antibodies open-label as per guidelines
Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors; HS_Tumor Necrosis Factor (TNF) Inhibitors	Drug: Anti-TNF; Subject receives anti-TNF antibodies open-label as per guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of molecular profiles over time	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with disease severity/remission	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with treatment	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 2, week 4, week 12, week 52
Changes of molecular profiles associated with treatment response	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 2, week 4, week 12, week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Eczema Area and Severity Index (EASI) score	Clinical severity score	Baseline and week 1, week 2, week 12, week 52
Change in Score of Atopic Dermatitis (SCORAD)	Clinical severity score	Baseline and week 1, week 2, week 12, week 52
Change in Psoriasis Area and Severity Index (PASI)	Clinical severity score	Baseline and week 1, week 2, week 12, week 52
Change in Hidradenitis Suppurativa Severity Score (IHS4)	Clinical severity score	Baseline and week 1, week 2, week 12, week 52

Collaborators and Investigators

• Sponsor: Prof. Dr. Stephan Weidinger
• Investigators: Principal Investigator: Stephan Weidinger, MD, Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 4, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): November 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Dermatitis; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Protein Kinase Inhibitors; Abrocitinib; Upadacitinib
• Other Study ID Numbers: A100/12; A100/12_A (Other Identifier: Ethics Committee Medical Faculty Kiel, Amendment 11MAR2017)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No