Evaluation of Cutaneous and Circulating Inflammatory Biomarkers in Hidradenitis Suppurativa and Atopic Dermatitis

Study Overview
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Brief Summary
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This non-intervention study will identify the biomarker profiles in hidradenitis suppurativa (HS) and atopic dermatitis (AD) (as a comparator) that would have the most utility in interventional studies evaluating efficacy during therapeutic intervention. Study data will also be used to correlate cellular/molecular changes in blood (cells and serum), and tissue, with clinical/histopathological phenotypes.

Detailed Description
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This study is an exploratory correlative study in subjects with HS or AD. Blood samples and skin biopsies will be collected from all subjects and used to assess the following: cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples, correlations between cutaneous and circulating inflammatory biomarkers and disease severity, effects of IRAK4 degradation on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients. De-identified routine clinical data that is collected will be correlated with the research findings.

Official Title
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Non-interventional Study to Evaluate Cutaneous and Circulating Inflammatory Biomarkers for a Novel IRAK4-targeted Therapeutic in Hidradenitis Suppurativa and Atopic Dermatitis Patient Samples

Conditions
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Hidradenitis Suppurativa, Dermatitis, Atopic

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Active HS or AD disease, diagnosed by PI Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA assessment. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to participate in the study. Exclusion Criteria: Patient is currently on a biologic or other immunosuppressive treatment for HS or AD. Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is longer Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hidradenitis suppurativa<br>Subjects with active mild, moderate, or severe HS disease using the HS-PGA assessment | |
| Atopic Dermatitis<br>Subjects with active moderate or severe AD disease using the PGA assessment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker Identification | Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples | Day 1 | 
| Determination of Biomarker Correlations | Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity | Day 1 | 
| Examination of IRAK4 Degradation Effects Ex Vivo | Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IRAK4