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Completed

NCT Number: NCT04440410

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

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.

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hidradenitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, L4C 9M7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. Biomarker Identification

    Time frame: Day 1

    Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples

  2. Determination of Biomarker Correlations

    Time frame: Day 1

    Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity

  3. Examination of IRAK4 Degradation Effects Ex Vivo

    Time frame: Day 1

    Examine effect of IRAK4 degrader on IRAK4 levels and downstream inflammatory biomarkers in ex vivo-treated whole blood from patients

Sponsors and collaborators

Lead sponsor

Kymera Therapeutics, Inc.

Industry

Collaborators

  • York Dermatology Clinic and Research Centre

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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