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The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

Primary Purpose

Atopic Dermatitis, Eczema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dupilumab Prefilled Syringe
Sponsored by
Jonathan A. Bernstein, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • history of adult onset atopic dermatitis

Exclusion Criteria:

-

Sites / Locations

  • Bernstein Clinical Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open-label

Arm Description

open-label

Outcomes

Primary Outcome Measures

The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD.
Data will be analyzed from skin punch biopsies from active skin lesions and uninvolved skin samples before and after treatment

Secondary Outcome Measures

To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD
Total IgE, TARC and eotaxin will be compared pre and post treatment

Full Information

First Posted
April 14, 2020
Last Updated
February 6, 2023
Sponsor
Jonathan A. Bernstein, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04358224
Brief Title
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
Official Title
The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 18, 2022 (Actual)
Study Completion Date
November 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jonathan A. Bernstein, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis
Detailed Description
The study consists of 9 visits. Duplimab will used in the treatment of adult onset atopic dermatitis. Qualified subjects will receive 5 dupilumab open-label injections. Skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. TARC and IgE levels will be obtained at the beginning and end of treatment. Subjects will complete daily diaries assessing atopic dermatitis symptoms. Patient reported out comes will be completed at each visit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
open-label
Arm Type
Other
Arm Description
open-label
Intervention Type
Biological
Intervention Name(s)
Dupilumab Prefilled Syringe
Other Intervention Name(s)
dupixent
Intervention Description
open-label
Primary Outcome Measure Information:
Title
The primary objective of this study is to correlate cutaneous transcriptomes with before and after Dupilumab treatment outcomes in patients who meet the clinical diagnostic criteria for adult onset AD.
Description
Data will be analyzed from skin punch biopsies from active skin lesions and uninvolved skin samples before and after treatment
Time Frame
after 6 months
Secondary Outcome Measure Information:
Title
To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD
Description
Total IgE, TARC and eotaxin will be compared pre and post treatment
Time Frame
after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of adult onset atopic dermatitis Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Bernstein
Organizational Affiliation
Bernstein Clinial Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
to be determined
IPD Sharing Time Frame
at end of trial
IPD Sharing Access Criteria
to be determined

Learn more about this trial

The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

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