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

February 6, 2023 updated by: Jonathan A. Bernstein, MD
The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Bernstein Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • history of adult onset atopic dermatitis

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: open-label
Biological: Dupilumab Prefilled Syringe
open-label
Other Names:
  • dupixent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: after 6 months
Data will be analyzed from skin punch biopsies from active skin lesions and uninvolved skin samples before and after treatment
after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD
Time Frame: after 6 months
Total IgE, TARC and eotaxin will be compared pre and post treatment
after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonathan A. Bernstein, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

November 18, 2022

Study Completion (ACTUAL)

November 18, 2022

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R668-AD-1830

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

to be determined

IPD Sharing Time Frame

at end of trial

IPD Sharing Access Criteria

to be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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