Dupilumab Phase 4 Study (DRS)

October 6, 2021 updated by: Jonathan Silverberg, Northwestern University

Dupilumab Registry Study

The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

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

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University Department of Dermatology

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

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with moderate-to-severe atopic dermatitis on dupilumab

Description

Inclusion Criteria:

  • Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
  • Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.

Exclusion Criteria:

  • Patients not on dupilumab
  • Those who do not comply with the study requirements
  • Those who do not provide informed consent

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dupilumab
Patients with moderated-to-severe atopic dermatitis who are receiving dupilumab as a standard of care
Biological: Dupilumab
Biologic (monoclonal antibody)
Other Names:
  • Dupixent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantified Itch Survey
Time Frame: 1 to 3 months
1 to 3 months
Quantified Sleep Survey
Time Frame: 1 to 3 months
1 to 3 months
Quantified Quality of Life Survey
Time Frame: 1 to 3 months
1 to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of any AEs by 24 months
Time Frame: 24 months
Will be determined based off of patient reported safety events
24 months
Occurrence of any infections by 24 months
Time Frame: 24 months
Will be determined based off of patient reported safety events
24 months
Occurrence of any SAEs by 24 months
Time Frame: 24 months
Will be determined based off of patient reported safety events
24 months

Collaborators and Investigators

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

Sponsor

Northwestern University

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)

October 16, 2017

Primary Completion (ACTUAL)

August 31, 2019

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

January 19, 2018

First Posted (ACTUAL)

January 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00088226

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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