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

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ClinicalTrials.gov Identifier: NCT04440410
Recruitment Status : Completed
First Posted : June 19, 2020
Last Update Posted : April 13, 2021
Sponsor:
Collaborator:
York Dermatology Clinic and Research Centre
Information provided by (Responsible Party):
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.

Condition or disease
Hidradenitis Suppurativa Dermatitis, Atopic

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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
Actual Study Start Date : May 28, 2020
Actual Primary Completion Date : March 24, 2021
Actual Study Completion Date : March 24, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Blood samples, skin biopsies


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440410


Locations
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Canada, Ontario
York Dermatology Clinic and Research Centre
Richmond Hill, Ontario, Canada, L4C 9M7
Sponsors and Collaborators
Kymera Therapeutics, Inc.
York Dermatology Clinic and Research Centre
Investigators
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Principal Investigator: Afsaneh Alavi, MD York Dermatology Clinic and Research Centre
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Responsible Party: Kymera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04440410    
Other Study ID Numbers: YDC-2
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kymera Therapeutics, Inc.:
IRAK4
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Dermatitis, Atopic
Dermatitis
Hidradenitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sweat Gland Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration