Study of Patients Receiving DUPIXENT® for Atopic Dermatitis (AD) (PROSE)

September 27, 2023 updated by: Regeneron Pharmaceuticals

A Prospective Observational Study of Patients Receiving DUPIXENT® for Atopic Dermatitis

A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study conducted to (1) characterize the patients who receive DUPIXENT® for AD in a real world setting with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD; (2) characterize real world use patterns of DUPIXENT® for AD (eg, most commonly used regimens by line of therapy, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching); (3) assess the long-term effectiveness of DUPIXENT® in AD patients in a real world setting; (4) assess comorbid atopic conditions, patterns of use and effects of treatment in comorbid atopic conditions in patients who receive DUPIXENT® for AD; and (5) collect safety data on study participants

Study Type

Observational

Enrollment (Actual)

858

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

  • Canada
      • Quebec, Canada, G1V 4X7
        • Regeneron Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8L 8E7
        • Regeneron Investigational Site
      • Markham, Ontario, Canada, L3P 1X2
        • Regeneron Investigational Site
      • Ottawa, Ontario, Canada, K1G 6G6
        • Regeneron Investigational Site
      • Peterborough, Ontario, Canada, K9J 5K2
        • Regeneron Investigational Site
      • Toronto, Ontario, Canada, M5G 1E2
        • Regeneron Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Regeneron Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Regeneron Investigational Site
    • California
      • Fountain Valley, California, United States, 92708
        • Regeneron Investigational Site
      • Laguna Hills, California, United States, 92653
        • Regeneron Investigational Site
      • Loma Linda, California, United States, 92354
        • Regeneron Investigational Site
      • Los Angeles, California, United States, 90025
        • Regeneron Investigational Site
      • Los Angeles, California, United States, 90067
        • Regeneron Investigational Site
      • Manhattan Beach, California, United States, 90266-2911
        • Regeneron Investigational Site
      • Newport Beach, California, United States, 92663
        • Regeneron Investigational Site
      • Oceanside, California, United States, 92056
        • Regeneron Investigational Site
      • Redondo Beach, California, United States, 90277
        • Regeneron Investigational Site
      • Riverside, California, United States, 92506-0174
        • Regeneron Investigational Site
      • Roseville, California, United States, 95661
        • Regeneron Investigational Site
      • San Diego, California, United States, 92123
        • Regeneron Investigational Site
      • Santa Monica, California, United States, 90404
        • Regeneron Investigational Site
      • Thousand Oaks, California, United States, 91320
        • Regeneron Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Regeneron Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Regeneron Investigational Site
      • Margate, Florida, United States, 33063
        • Regeneron Investigational Site
      • West Palm Beach, Florida, United States, 33406
        • Regeneron Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342-1703
        • Regeneron Investigational Site
      • Macon, Georgia, United States, 31217
        • Regeneron Investigational Site
      • Marietta, Georgia, United States, 30060-1047
        • Regeneron Investigational Site
      • Marietta, Georgia, United States, 30152
        • Regeneron Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • Regeneron Investigational Site
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Regeneron Investigational Site
      • Chicago, Illinois, United States, 60654
        • Regeneron Investigational Site
      • La Grange Park, Illinois, United States, 60526
        • Regeneron Investigational Site
      • Skokie, Illinois, United States, 60077
        • Regeneron Investigational Site
      • Springfield, Illinois, United States, 62604
        • Regeneron Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Regeneron Investigational Site
      • Plainfield, Indiana, United States, 46168
        • Regeneron Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Regeneron Investigational Site
    • Kentucky
      • Corbin, Kentucky, United States, 40701
        • Regeneron Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Regeneron Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Regeneron Investigational Site
      • Towson, Maryland, United States, 21204
        • Regeneron Investigational Site
      • Upper Marlboro, Maryland, United States, 20772
        • Regeneron Investigational Site
      • White Marsh, Maryland, United States, 21162
        • Regeneron Investigational Site
    • Massachusetts
      • Quincy, Massachusetts, United States, 02169
        • Regeneron Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • Regeneron Investigational Site
      • Bay City, Michigan, United States, 48706
        • Regeneron Investigational Site
      • Troy, Michigan, United States, 48084
        • Regeneron Investigational Site
      • Warren, Michigan, United States, 48088
        • Regeneron Investigational Site
    • Missouri
      • Columbia, Missouri, United States, 65212-0001
        • Regeneron Investigational Site
      • Kirksville, Missouri, United States, 63501
        • Regeneron Investigational Site
      • Saint Louis, Missouri, United States, 63110
        • Regeneron Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • Regeneron Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Regeneron Investigational Site
      • Las Vegas, Nevada, United States, 89144
        • Regeneron Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Regeneron Investigational Site
      • East Windsor, New Jersey, United States, 08520
        • Regeneron Investigational Site
      • Edison, New Jersey, United States, 08820
        • Regeneron Investigational Site
      • Piscataway, New Jersey, United States, 08854
        • Regeneron Investigational Site
    • New York
      • Bronx, New York, United States, 10467-2401
        • Regeneron Investigational Site
      • Elmhurst, New York, United States, 11373-4831
        • Regeneron Investigational Site
      • Forest Hills, New York, United States, 11374
        • Regeneron Investigational Site
      • Garden City, New York, United States, 11530
        • Regeneron Investigational Site
      • Kew Gardens, New York, United States, 11374
        • Regeneron Investigational Site
      • Lake Success, New York, United States, 11042
        • Regeneron Investigational Site
      • Manhasset, New York, United States, 11030
        • Regeneron Investigational Site
      • Mineola, New York, United States, 11501
        • Regeneron Investigational Site
      • Mount Vernon, New York, United States, 10552
        • Regeneron Investigational Site
      • New York, New York, United States, 10029
        • Regeneron Investigational Site
      • New York, New York, United States, 10012-1354
        • Regeneron Investigational Site
      • New York, New York, United States, 10016
        • Regeneron Investigational Site
      • New York, New York, United States, 10075
        • Regeneron Investigational Site
      • Troy, New York, United States, 12180
        • Regeneron Investigational Site
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Regeneron Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44333
        • Regeneron Investigational Site
      • Athens, Ohio, United States, 45701
        • Regeneron Investigational Site
      • Bexley, Ohio, United States, 43209
        • Regeneron Investigational Site
      • Marion, Ohio, United States, 43302
        • Regeneron Investigational Site
      • Mason, Ohio, United States, 45040
        • Regeneron Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Regeneron Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Regeneron Investigational Site
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
        • Regeneron Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Regeneron Investigational Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Regeneron Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • Regeneron Investigational Site
      • Yardley, Pennsylvania, United States, 19067
        • Regeneron Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Regeneron Investigational Site
      • North Charleston, South Carolina, United States, 29420-4211
        • Regeneron Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • Regeneron Investigational Site
      • Dallas, Texas, United States, 75231
        • Regeneron Investigational Site
      • Grapevine, Texas, United States, 76051
        • Regeneron Investigational Site
      • San Antonio, Texas, United States, 78205
        • Regeneron Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Regeneron Investigational Site
      • Sugar Land, Texas, United States, 77479
        • Regeneron Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22204
        • Regeneron Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Regeneron Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Regeneron Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Regeneron Investigational Site

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population comprises adult and adolescent patients (male or female, ≥12 years old), who are initiating treatment with DUPIXENT® for AD according to the country-specific prescribing information.

Description

Key Inclusion Criteria:

  • Male or female, 12 years of age or older at the baseline visit. NOTE: Adolescent patients (at least 12 years old, but less than 18 years) are eligible in the US or Canada only after DUPIXENT receives the respective country's regulatory approval for use in this age group.
  • Initiating treatment with DUPIXENT® as standard-of-care for AD according to the country-specific prescribing information (Note: Participants will be screened when they received their initial prescription for DUPIXENT®).
  • Willing and able to comply with study-related activities.
  • Able to understand and complete study-related questionnaires.
  • Provide signed informed consent or parental/legal guardian consent plus patient assent, where applicable.

Key Exclusion Criteria:

  • Patients who have a contraindication to the drug according to the country-specific prescribing information label.
  • Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the patient from adequately completing the schedule of visits and assessments.
  • Prior use of dupilumab within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registry Assessment: Baseline Characteristics
Time Frame: At baseline (day when DUPIXENT treatment is initiated)
Medical history
At baseline (day when DUPIXENT treatment is initiated)
Registry Assessment: Baseline Characteristic
Time Frame: At baseline (day when DUPIXENT treatment is initiated)
Socio-demographics
At baseline (day when DUPIXENT treatment is initiated)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis
Time Frame: Baseline to month 60
Percentage of BSA affected by AD assessed for each major section of the body
Baseline to month 60
Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)
Time Frame: Baseline to month 60
Measure used in clinical practice and clinical trials to assess the severity and extent of AD
Baseline to month 60
Registry (Physician) Assessment: Overall Disease Severity scale
Time Frame: Baseline to month 60
Questionnaire used to characterizing the severity of AD on a 4-point scale (0=No disease, 1=Minimal disease, 2=Mild disease, 3=Moderate disease, 4=Severe disease)
Baseline to month 60
Registry (Participant) Assessment: Patient Oriented Eczema Measure
Time Frame: Baseline to month 60
Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults
Baseline to month 60
Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)
Time Frame: Baseline to month 60
Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.
Baseline to month 60
Registry (Participant) Assessment: Skin Pain or Soreness NRS
Time Frame: Baseline to month 60
Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS
Baseline to month 60
Registry (Participant) Assessment: Skin Feeling Hot NRS
Time Frame: Baseline to month 60
Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS
Baseline to month 60
Registry (Participant) Assessment: Skin Sensitivity NRS
Time Frame: Baseline to month 60
Individual NRS used to rate skin sensitivity using a 0 to 10 NRS
Baseline to month 60
Registry (Participant) Assessment: Sleep Disturbance NRS
Time Frame: Baseline to month 60
Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS
Baseline to month 60
Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale
Time Frame: Baseline to month 60
Rate of overall well-being on a 5-point scale.
Baseline to month 60
Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)
Time Frame: Baseline to month 60
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) in adults
Baseline to month 60
Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)
Time Frame: Baseline to month 60
Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics.
Baseline to month 60
Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)
Time Frame: Baseline to month 60
Questionnaire to assess the impact of AD on productivity.
Baseline to month 60
Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire
Time Frame: Baseline to month 60
Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD.
Baseline to month 60
Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire
Time Frame: Baseline to month 60
Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.
Baseline to month 60
Registry (Participant) Assessment: Missed School Days
Time Frame: Baseline to month 60
Questionnaire to assess the number of missed school days since the last study assessment of adolescent patients (aged ≥ 12 to < 18 years) who are enrolled in school.
Baseline to month 60
Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)
Time Frame: Baseline to month 60
5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.
Baseline to month 60
Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)
Time Frame: Baseline to month 60
Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.
Baseline to month 60
Registry (Participant) Assessment: Changes in Concurrent Conditions
Time Frame: Baseline to month 60
Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).
Baseline to month 60
Registry (Participant) Assessment: Overall Health State
Time Frame: Baseline to month 60
Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).
Baseline to month 60

Collaborators and Investigators

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

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Investigators

  • Study Director: Medical Affairs, Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 6, 2018

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

February 4, 2018

First Posted (Actual)

February 9, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R668-AD-1762

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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