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

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.

Study Overview

• Status: Completed
• Conditions: Dermatitis, Atopic; Hidradenitis Suppurativa

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Hidradenitis suppurativa; Subjects with active mild, moderate, or severe HS disease using the HS-PGA assessment
Atopic Dermatitis; Subjects with active moderate or severe AD disease using the PGA assessment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kymera Therapeutics, Inc.
• Collaborators: York Dermatology Clinic and Research Centre
• Investigators: Principal Investigator: Afsaneh Alavi, MD, York Dermatology Clinic and Research Centre

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 28, 2020
• Primary Completion (ACTUAL): March 24, 2021
• Study Completion (ACTUAL): March 24, 2021

Study Registration Dates

• First Submitted: June 1, 2020
• First Submitted That Met QC Criteria: June 17, 2020
• First Posted (ACTUAL): June 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: IRAK4
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Genetic; Skin Diseases, Infectious; Hypersensitivity; Suppuration; Skin Diseases, Bacterial; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: YDC-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No