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

NCT ID: NCT04358224

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-11-18

Brief Summary

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

Detailed Description

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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

Conditions

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Atopic Dermatitis Eczema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open-label

open-label

Group Type OTHER

Dupilumab Prefilled Syringe

Intervention Type BIOLOGICAL

open-label

Interventions

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Dupilumab Prefilled Syringe

open-label

Intervention Type BIOLOGICAL

Other Intervention Names

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dupixent

Eligibility Criteria

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Inclusion Criteria

* history of adult onset atopic dermatitis

Exclusion Criteria

\-
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonathan A. Bernstein, MD

OTHER

Sponsor Role lead

Responsible Party

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Jonathan A. Bernstein, MD

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jonathan Bernstein

Role: PRINCIPAL_INVESTIGATOR

Bernstein Clinial Research Center

Locations

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Bernstein Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R668-AD-1830

Identifier Type: -

Identifier Source: org_study_id

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