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

Dermatitis, Atopic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04440410
• Other study ID #: YDC-2
• Status: Completed
• Start date: May 28, 2020
• Est. completion date: March 24, 2021

Study information

• Verified date: April 2021
• Source: Kymera Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 24, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Hidradenitis
• Hidradenitis Suppurativa

Locations

Country	Name	City	State
Canada	York Dermatology Clinic and Research Centre	Richmond Hill	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Kymera Therapeutics, Inc.	York Dermatology Clinic and Research Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarker Identification	Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples	Day 1
Primary	Determination of Biomarker Correlations	Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity	Day 1
Primary	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