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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date June 1, 2020
First Posted Date June 19, 2020
Last Update Posted Date April 13, 2021
Actual Study Start Date May 28, 2020
Actual Primary Completion Date March 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 17, 2020)
  • Biomarker Identification [ Time Frame: Day 1 ]
    Assessment of cutaneous and circulating inflammatory biomarkers and IRAK4 target levels in primary samples
  • Determination of Biomarker Correlations [ Time Frame: Day 1 ]
    Determine correlations between cutaneous and circulating inflammatory biomarkers and disease severity
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Cutaneous and Circulating Inflammatory Biomarkers in Hidradenitis Suppurativa and Atopic Dermatitis
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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood samples, skin biopsies
Sampling Method Non-Probability Sample
Study Population Patients with active mild, moderate, or severe HS or active moderate or severe AD disease.
Condition
  • Hidradenitis Suppurativa
  • Dermatitis, Atopic
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 17, 2020)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date March 24, 2021
Actual Primary Completion Date March 24, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04440410
Other Study ID Numbers YDC-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kymera Therapeutics, Inc.
Study Sponsor Kymera Therapeutics, Inc.
Collaborators York Dermatology Clinic and Research Centre
Investigators
Principal Investigator: Afsaneh Alavi, MD York Dermatology Clinic and Research Centre
PRS Account Kymera Therapeutics, Inc.
Verification Date April 2021