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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04440410

Enrollment

Registered

2020-06-19

Start date

2020-05-28

Completion date

2021-03-24

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic, Hidradenitis Suppurativa

Keywords

IRAK4

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age 18 or older 2. Active HS or AD disease, diagnosed by PI 3. Patients with mild (HS only), moderate, or severe disease using the HS-PGA or PGA assessment. 4. 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

1. Patient is currently on a biologic or other immunosuppressive treatment for HS or AD. 2. Use of biologic treatment for HS or AD within 3 months or 5 half-lives, whichever is longer 3. Use of non-biologic immunosuppressive treatment (eg. Cyclosporin) in the last 4 weeks.

Design outcomes

Primary

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

Countries

Canada

Outcome results