Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
Kiel, 24105, Germany
Location status: Recruiting
Location contact
Sascha Gerdes, MD
CONTACT
Stephan Weidinger, MD
CONTACT
NCT Number: NCT03358693
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.
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Observational
Kiel, 24105, Germany
Location status: Recruiting
Sascha Gerdes, MD
CONTACT
Stephan Weidinger, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subject receives anti-TNF antibodies open-label as per guidelines
Subject receives anti-IL12/23 antibodies open-label as per guidelines
Subject receives anti-IL17 antibodies open-label as per guidelines
Subject receives Dupilumab open-label as per guidelines
Subject receives anti-IL23 antibodies open-label as per guidelines
Subject receives Baricitinib open-label as per guidelines
Subject receives Abrocitinib open-label as per guidelines
Subject receives Upadacitinib open-label as per guidelines
Subject receives Tralokinumab open-label as per guidelines
Subject receives Lebrikizumab open-label as per guidelines
Subject receives Nemolizumab open-label as per guidelines
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 2, week 4, week 12, week 52
Changes of immune cell composition, transcriptome, proteome and microbiome signatures
Time frame: Baseline and week 1, week 2, week 12, week 52
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Clinical severity score
Time frame: Baseline and week 1, week 2, week 12, week 52
Clinical severity score
Contact information is provided by the study sponsor or research team.
Sascha Gerdes, MD
CONTACT
Stephan Weidinger, MD
CONTACT
Prof. Dr. Stephan Weidinger
Other
Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders
Acronym: MSID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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