Molecular Signatures in Inflammatory Skin Disease (MSID)

Prof. Dr. Stephan Weidinger

Status: Enrolling

Conditions: Atopic Dermatitis; Psoriasis

Treatments: Drug: Upadacitinib; Drug: Abrocitinib; Drug: Anti-IL12/23; Drug: Anti-IL23; Drug: Tralokinumab; Drug: Anti-TNF; Drug: Lebrikizumab; Drug: Anti-IL17; Drug: Baricitinib; Drug: Nemolizumab; Drug: Dupilumab

Study type: Observational

Funder types: Other

Identifiers

NCT03358693

A100/12_A (Other Identifier)

A100/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

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.

Trial design

300 participants in 13 patient groups

Psoriasis patients receiving Tumor Necrosis Factor (TNF) Inhibitors

Description:

Pso_Tumor Necrosis Factor (TNF) Inhibitors

Treatment:

Drug: Anti-TNF

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

Description:

Interleukin (IL)-12/23 Inhibitors

Treatment:

Drug: Anti-IL12/23

Psoriasis patients receiving Interleukin (IL)-17 Inhibitors

Description:

Pso_Interleukin (IL)-17 Inhibitors

Treatment:

Drug: Anti-IL17

Atopic dermatitis patients receiving dupilumab

Description:

Dupilumab

Treatment:

Drug: Dupilumab

Atopic dermatitis patients receiving lebrikizumab

Description:

Brodalumab

Treatment:

Drug: Lebrikizumab

Atopic dermatitis patients receiving tralokinumab

Description:

Tralokinumab

Treatment:

Drug: Tralokinumab

Atopic dermatitis patients receiving baricitinib

Description:

Baricitinib

Treatment:

Drug: Baricitinib

Atopic dermatitis patients receiving abrocitinib

Description:

Abrocitinib

Treatment:

Drug: Abrocitinib

Atopic dermatitis patients receiving upadacitinib

Description:

Upadacitinib

Treatment:

Drug: Upadacitinib

Psoriasis patients receiving Interleukin (IL)-23 Inhibitors

Description:

Interleukin (IL)-23 Inhibitors

Treatment:

Drug: Anti-IL23

Atopic dermatitis patients receiving Interleukin (IL)-31 Inhibitors

Description:

Interleukin (IL)-31 Inhibitors

Treatment:

Drug: Nemolizumab

Hidradenitis patients receiving Interleukin (IL)-17 Inhibitors

Description:

HS_Interleukin (IL)-17 Inhibitors

Treatment:

Drug: Anti-IL17

Hidradenitis patients receiving Tumor Necrosis Factor (TNF) Inhibitors

Description:

HS_Tumor Necrosis Factor (TNF) Inhibitors

Treatment:

Drug: Anti-TNF