NCT04358224

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

April 14, 2020

Last Update Submit

February 6, 2023

Conditions

Atopic DermatitisEczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To investigate possible influence of Dupilumab on serologic protein biomarkers in patients with adult onset AD

    after 6 months

Study Arms (1)

open-label

OTHER

open-label

Biological: Dupilumab Prefilled Syringe

Interventions

Dupilumab Prefilled SyringeBIOLOGICAL

open-label

Also known as: dupixent
open-label

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of adult onset atopic dermatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bernstein Clinical Research Center

Cincinnati, Ohio, 45231, United States

Location

MeSH Terms

Conditions

Dermatitis, AtopicEczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Jonathan Bernstein

    Bernstein Clinial Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 24, 2020

Study Start

September 1, 2020

Primary Completion

November 18, 2022

Study Completion

November 18, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

to be determined

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
at end of trial
Access Criteria
to be determined

Locations

US(1)