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NCT04358224 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04358224
Other study ID # R668-AD-1830
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date November 18, 2022

Study information
Verified date February 2023
Source Bernstein Clinical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date November 18, 2022
Est. primary completion date November 18, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria: - history of adult onset atopic dermatitis Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Dupilumab Prefilled Syringe
open-label

Locations
Country Name City State
United States Bernstein Clinical Research Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Jonathan A. Bernstein, MD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 after 6 months
Secondary 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 after 6 months
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