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| ID | Type | Description | Link |
|---|---|---|---|
| A100/12_A | Other Identifier | Ethics Committee Medical Faculty Kiel, Amendment 11MAR2017 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors | Pso_Tumor Necrosis Factor (TNF) Inhibitors |
| |
| Psoriasis patients receiving Interleukin (IL)-12/23 Inhibitors | Interleukin (IL)-12/23 Inhibitors |
| |
| Psoriasis patients receiving Interleukin (IL)-17 Inhibitors | Pso_Interleukin (IL)-17 Inhibitors |
| |
| Atopic dermatitis patients receiving dupilumab | Dupilumab |
| |
| Atopic dermatitis patients receiving lebrikizumab | Brodalumab |
| |
| Atopic dermatitis patients receiving tralokinumab | Tralokinumab |
| |
| Atopic dermatitis patients receiving baricitinib |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-TNF | Drug | Subject receives anti-TNF antibodies open-label as per guidelines |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic inflammatory skin disease who receive systemic therapy from their treating dermatologist during routine care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephan Weidinger, MD | Contact | 004943150021101 | sweidinger@dermatology.uni-kiel.de | |
| Sascha Gerdes, MD | Contact | 004943150021101 | sgerdes@dermatology.uni-kiel.de |
| Name | Affiliation | Role |
|---|---|---|
| Stephan Weidinger, MD | Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel | Recruiting | Kiel | 24105 | Germany |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
| C000596027 | baricitinib |
| C000634427 | abrocitinib |
| C000613732 | upadacitinib |
| C574065 | tralokinumab |
| C561806 | lebrikizumab |
| C000612881 | nemolizumab |
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Blood, swabs, tape strips, skin biopsies (only adults)
Baricitinib |
|
| Atopic dermatitis patients receiving abrocitinib | Abrocitinib |
|
| Atopic dermatitis patients receiving upadacitinib | Upadacitinib |
|
| Psoriasis patients receiving Interleukin (IL)-23 Inhibitors | Interleukin (IL)-23 Inhibitors |
|
| Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors | Interleukin (IL)-31 Inhibitors |
|
| Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors | HS_Interleukin (IL)-17 Inhibitors |
|
| Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors | HS_Tumor Necrosis Factor (TNF) Inhibitors |
|
| 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 |
|
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |