Molecular Signatures in Inflammatory Skin Disease

NCT03358693 | Recruiting DMC FDA Drug

• 2 other identifiers: A100/12A100/12_A
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Psoriasis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Change in Eczema Area and Severity Index (EASI) score

  Baseline and week 1, week 2, week 12, week 52

• Change in Score of Atopic Dermatitis (SCORAD)

  Baseline and week 1, week 2, week 12, week 52

• Change in Psoriasis Area and Severity Index (PASI)

  Baseline and week 1, week 2, week 12, week 52

• Change in Hidradenitis Suppurativa Severity Score (IHS4)

  Baseline and week 1, week 2, week 12, week 52

Study Arms (13)

Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors

Pso\_Tumor Necrosis Factor (TNF) Inhibitors

Drug: Anti-TNF

Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors

Interleukin (IL)-12/23 Inhibitors

Drug: Anti-IL12/23

Psoriasis patients receiving Interleukin (IL)-17 Inhibitors

Pso\_Interleukin (IL)-17 Inhibitors

Drug: Anti-IL17

Atopic dermatitis patients receiving dupilumab

Dupilumab

Drug: Dupilumab

Atopic dermatitis patients receiving lebrikizumab

Brodalumab

Drug: Lebrikizumab

Atopic dermatitis patients receiving tralokinumab

Tralokinumab

Drug: Tralokinumab

Atopic dermatitis patients receiving baricitinib

Baricitinib

Drug: Baricitinib

Atopic dermatitis patients receiving abrocitinib

Abrocitinib

Drug: Abrocitinib

Atopic dermatitis patients receiving upadacitinib

Upadacitinib

Drug: Upadacitinib

Psoriasis patients receiving Interleukin (IL)-23 Inhibitors

Interleukin (IL)-23 Inhibitors

Drug: Anti-IL23

Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors

Interleukin (IL)-31 Inhibitors

Drug: Nemolizumab

Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors

HS\_Interleukin (IL)-17 Inhibitors

Drug: Anti-IL17

Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors

HS\_Tumor Necrosis Factor (TNF) Inhibitors

Drug: Anti-TNF

Interventions

Anti-TNF DRUG

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

Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors; Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors

Anti-IL12/23 DRUG

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

Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors

Anti-IL17 DRUG

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

Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors; Psoriasis patients receiving Interleukin (IL)-17 Inhibitors

Dupilumab DRUG

Subject receives Dupilumab open-label as per guidelines

Atopic dermatitis patients receiving dupilumab

Anti-IL23 DRUG

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

Psoriasis patients receiving Interleukin (IL)-23 Inhibitors

Baricitinib DRUG

Subject receives Baricitinib open-label as per guidelines

Atopic dermatitis patients receiving baricitinib

Abrocitinib DRUG

Subject receives Abrocitinib open-label as per guidelines

Atopic dermatitis patients receiving abrocitinib

Upadacitinib DRUG

Subject receives Upadacitinib open-label as per guidelines

Atopic dermatitis patients receiving upadacitinib

Tralokinumab DRUG

Subject receives Tralokinumab open-label as per guidelines

Atopic dermatitis patients receiving tralokinumab

Lebrikizumab DRUG

Subject receives Lebrikizumab open-label as per guidelines

Atopic dermatitis patients receiving lebrikizumab

Nemolizumab DRUG

Subject receives Nemolizumab open-label as per guidelines

Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. Stephan Weidinger: lead

Study Sites (1)

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, swabs, tape strips, skin biopsies (only adults)

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis

Interventions

dupilumab; baricitinib; abrocitinib; upadacitinib; tralokinumab; lebrikizumab; nemolizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous

Study Officials

• Stephan Weidinger, MD

  Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Weidinger, MD

CONTACT

004943150021101; sweidinger@dermatology.uni-kiel.de

Sascha Gerdes, MD

CONTACT

004943150021101; sgerdes@dermatology.uni-kiel.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Inflammatory Skin Disease Center

Study Record Dates

• First Submitted: November 4, 2017
• First Posted: November 30, 2017
• Study Start: January 20, 2017
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)