SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)

Summary

The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are:

* Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO?
* How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers?
* Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice?
* How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO)
* How do biomarker levels change over time in response to treatment in these patient populations?
* Which skin tissue biomarkers are associated with disease progression or treatment response?
* How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes?
* Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time?

Researchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions.

Participants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4/13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\*; CLE: TSC, HCQ, MTX)

\*once approved and reimbursed in the Netherlands

Participants will:

* Take the prescribed medication for their skin disease (in line with standard care in the Netherlands).
* Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional).
* Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional).
* Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.

Conditions

• Chronic Spontaneous Urticaria (CSU)
• Hidradenitis Suppurativa (HS)
• Psoriasis (PsO)
• Atopic Dermatitis (AD)
• CTCL/ Mycosis Fungoides

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Amsterdam University Medical Center

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• University Medical Center Groningen

  collaborator OTHER

• Centre for Human Drug Research, Netherlands

  collaborator OTHER

• Leiden University Medical Center

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-07-29

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• Netherlands

Study Locations