NCT04440410

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
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Kymera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa
• Dermatitis, Atopic

Timeline

• Start date: 2020-05-28
• Primary completion: 2021-03-24
• Completion: 2021-03-24
• First posted: 2020-06-19
• Last updated: 2021-04-13

Locations

1 site across 1 country: Canada