Molecular Signatures in Inflammatory Skin Disease
- Conditions
- Atopic DermatitisPsoriasis
- Interventions
- Drug: Anti-IL12/23Drug: Anti-IL17Drug: Anti-IL23Drug: Anti-TNF
- Registration Number
- NCT03358693
- Lead Sponsor
- Prof. Dr. Stephan Weidinger
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors Anti-IL12/23 Interleukin (IL)-12/23 Inhibitors Psoriasis patients receiving Interleukin (IL)-17 Inhibitors Anti-IL17 Pso_Interleukin (IL)-17 Inhibitors Atopic dermatitis patients receiving abrocitinib Abrocitinib Abrocitinib Atopic dermatitis patients receiving upadacitinib Upadacitinib Upadacitinib Atopic dermatitis patients receiving dupilumab Dupilumab Dupilumab Atopic dermatitis patients receiving lebrikizumab Lebrikizumab Brodalumab Atopic dermatitis patients receiving baricitinib Baricitinib Baricitinib Atopic dermatitis patients receiving tralokinumab Tralokinumab Tralokinumab Psoriasis patients receiving Interleukin (IL)-23 Inhibitors Anti-IL23 Interleukin (IL)-23 Inhibitors Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors Nemolizumab Interleukin (IL)-31 Inhibitors Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors Anti-IL17 HS_Interleukin (IL)-17 Inhibitors Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors Anti-TNF HS_Tumor Necrosis Factor (TNF) Inhibitors Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors Anti-TNF Pso_Tumor Necrosis Factor (TNF) Inhibitors
- Primary Outcome Measures
Name Time Method Changes of molecular profiles over time Baseline and week 2, week 4, week 12, week 52 Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with disease severity/remission Baseline and week 2, week 4, week 12, week 52 Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatment Baseline and week 2, week 4, week 12, week 52 Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Changes of molecular profiles associated with treatment response Baseline and week 2, week 4, week 12, week 52 Changes of immune cell composition, transcriptome, proteome and microbiome signatures
- Secondary Outcome Measures
Name Time Method Change in Eczema Area and Severity Index (EASI) score Baseline and week 1, week 2, week 12, week 52 Clinical severity score
Change in Score of Atopic Dermatitis (SCORAD) Baseline and week 1, week 2, week 12, week 52 Clinical severity score
Change in Psoriasis Area and Severity Index (PASI) Baseline and week 1, week 2, week 12, week 52 Clinical severity score
Change in Hidradenitis Suppurativa Severity Score (IHS4) Baseline and week 1, week 2, week 12, week 52 Clinical severity score
Trial Locations
- Locations (1)
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
🇩🇪Kiel, Germany
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel🇩🇪Kiel, GermanyStephan Weidinger, MDContactSascha Gerdes, MDContact