Molecular Signatures in Inflammatory Skin Disease

Psoriasis Clinical Trial

— MSID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03358693
• Other study ID #: A100/12
• Secondary ID: A100/12_A
• Status: Recruiting
• Start date: January 20, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: July 2023
• Source: University Hospital Schleswig-Holstein
• Contact: Stephan Weidinger, MD
• Phone: 004943150021101
• Email: sweidinger[@]dermatology.uni-kiel.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent and comply with the protocol

• Diagnosis of chronic psoriasis or atopic dermatitis

• PASI score = 10 or EASI score = 16

• Investigator Global Assessment (IGA) = 3

• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Psoriasis

Intervention

Drug:
• Ustekinumab
Subject receives Ustekinumab open-label as per guidelines
• Infliximab
Subject receives Infliximab open-label as per guidelines
• Secukinumab
Subject receives Secukinumab open-label as per guidelines
• Dupilumab
Subject receives Dupilumab open-label as per guidelines
• Brodalumab
Subject receives Brodalumab open-label as per guidelines
• Ixekizumab
Subject receives Ixekizumab open-label as per guidelines
• Baricitinib
Subject receives Baricitinib open-label as per guidelines
• Abrocitinib
Subject receives Abrocitinib open-label as per guidelines
• Upadacitinib
Subject receives Upadacitinib open-label as per guidelines
• Tralokinumab
Subject receives Tralokinumab open-label as per guidelines

Locations

Country	Name	City	State
Germany	Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Stephan Weidinger

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of molecular profiles over time	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 1, week 2, week 12, week 52
Primary	Changes of molecular profiles associated with disease severity/remission	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 1, week 2, week 12, week 52
Primary	Changes of molecular profiles associated with treatment	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and day 1, day 7, day 14, day 84, day 364
Primary	Changes of molecular profiles associated with treatment response	Changes of immune cell composition, transcriptome, proteome and microbiome signatures	Baseline and week 1, week 2, week 12, week 52
Secondary	Change in Eczema Area and Severity Index (EASI) score	Clinical severity score	Baseline and week 1, week 2, week 12, week 52
Secondary	Change in Score of Atopic Dermatitis (SCORAD)	Clinical severity score	Baseline and week 1, week 2, week 12, week 52
Secondary	Change in Psoriasis Area Severity Index (PASI) score	Clinical severity score	Baseline and week 1, week 2, week 12, week 52