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Molecular Signatures in Inflammatory Skin Disease

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03358693
Acronym
MSID
Enrollment
300
Registered
2017-11-30
Start date
2017-01-20
Completion date
2029-12-31
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Psoriasis

Brief 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.

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

DRUGNemolizumab

Subject receives Nemolizumab open-label as per guidelines

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

Sponsors

Prof. Dr. Stephan Weidinger
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes of molecular profiles associated with treatment responseBaseline and week 2, week 4, week 12, week 52Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with disease severity/remissionBaseline and week 2, week 4, week 12, week 52Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatmentBaseline and week 2, week 4, week 12, week 52Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles over timeBaseline and week 2, week 4, week 12, week 52Changes of immune cell composition, transcriptome, proteome and microbiome signatures

Secondary

MeasureTime frameDescription
Change in Eczema Area and Severity Index (EASI) scoreBaseline and week 1, week 2, week 12, week 52Clinical severity score
Change in Score of Atopic Dermatitis (SCORAD)Baseline and week 1, week 2, week 12, week 52Clinical severity score
Change in Psoriasis Area and Severity Index (PASI)Baseline and week 1, week 2, week 12, week 52Clinical severity score
Change in Hidradenitis Suppurativa Severity Score (IHS4)Baseline and week 1, week 2, week 12, week 52Clinical severity score

Countries

Germany

Contacts

Primary ContactStephan Weidinger, MD
sweidinger@dermatology.uni-kiel.de004943150021101
Backup ContactSascha Gerdes, MD
sgerdes@dermatology.uni-kiel.de004943150021101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026