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

Completed

• Conditions: Dermatitis, Atopic; Hidradenitis Suppurativa

• Registration Number: NCT04440410
• Lead Sponsor: Kymera Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2020-05-28
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Primary Completion: 2021-03-24
• Study Completion: 2021-03-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-12
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

York Dermatology Clinic and Research Centre; 🇨🇦 Richmond Hill, Ontario, Canada