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Dermatitis, AtopicPROSENCT03428646

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

An observational study of Dermatitis, Atopic, run by Regeneron Pharmaceuticals at 99 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab) Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Dermatitis, Atopic
What is being tested?
Dupilumab
How many people
858 participants
Where
99 sitesin 2 countries
Study dates
6 Apr 2018to 28 Jul 2027
How long will I take part?
60 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

99 sites in 2 countries.

99 sites in 2 countries

United States93 sites

  • Regeneron Investigational Site

    Akron, Ohio, 44333

  • Regeneron Investigational Site

    Ann Arbor, Michigan, 48103

  • Regeneron Investigational Site

    Arlington, Virginia, 22204

  • Regeneron Investigational Site

    Athens, Ohio, 45701

  • Regeneron Investigational Site

    Atlanta, Georgia, 30342-1703

  • Regeneron Investigational Site

    Bay City, Michigan, 48706

  • Regeneron Investigational Site

    Bellaire, Texas, 77401

  • Regeneron Investigational Site

    Bellevue, Washington, 98004

  • Regeneron Investigational Site

    Bexley, Ohio, 43209

  • Regeneron Investigational Site

    Birmingham, Alabama, 35205

  • Regeneron Investigational Site

    Blue Bell, Pennsylvania, 19422

  • Regeneron Investigational Site

    Brick, New Jersey, 08724

  • Regeneron Investigational Site

    Champaign, Illinois, 61820

  • Regeneron Investigational Site

    Charleston, South Carolina, 29425

  • Regeneron Investigational Site

    Chicago, Illinois, 60654

  • Regeneron Investigational Site

    Columbia, Missouri, 65212-0001

  • Regeneron Investigational Site

    Concord, North Carolina, 28025

  • Regeneron Investigational Site

    Coral Gables, Florida, 33146

  • Regeneron Investigational Site

    Corbin, Kentucky, 40701

  • Regeneron Investigational Site

    Dallas, Texas, 75231

  • Regeneron Investigational Site

    East Windsor, New Jersey, 08520

  • Regeneron Investigational Site

    Edison, New Jersey, 08820

  • Regeneron Investigational Site

    Elmhurst, New York, 11373-4831

  • Regeneron Investigational Site

    Forest Hills, New York, 11374

  • Regeneron Investigational Site

    Fort Wayne, Indiana, 46804

  • Regeneron Investigational Site

    Fountain Valley, California, 92708

  • Regeneron Investigational Site

    Garden City, New York, 11530

  • Regeneron Investigational Site

    Gilbert, Arizona, 85234

  • Regeneron Investigational Site

    Grapevine, Texas, 76051

  • Regeneron Investigational Site

    Henderson, Nevada, 89052

  • Regeneron Investigational Site

    Kew Gardens, New York, 11374

  • Regeneron Investigational Site

    Kirksville, Missouri, 63501

  • Regeneron Investigational Site

    La Grange Park, Illinois, 60526

  • Regeneron Investigational Site

    Laguna Hills, California, 92653

  • Regeneron Investigational Site

    Lake Success, New York, 11042

  • Regeneron Investigational Site

    Las Vegas, Nevada, 89144

  • Regeneron Investigational Site

    Lincoln, Nebraska, 68505

  • Regeneron Investigational Site

    Loma Linda, California, 92354

  • Regeneron Investigational Site

    Los Angeles, California, 90025

  • Regeneron Investigational Site

    Los Angeles, California, 90067

  • Regeneron Investigational Site

    Louisville, Kentucky, 40202

  • Regeneron Investigational Site

    Macon, Georgia, 31217

  • Regeneron Investigational Site

    Manhasset, New York, 11030

  • Regeneron Investigational Site

    Manhattan Beach, California, 90266-2911

  • Regeneron Investigational Site

    Margate, Florida, 33063

  • Regeneron Investigational Site

    Marietta, Georgia, 30060-1047

  • Regeneron Investigational Site

    Marietta, Georgia, 30152

  • Regeneron Investigational Site

    Marion, Ohio, 43302

  • Regeneron Investigational Site

    Mason, Ohio, 45040

  • Regeneron Investigational Site

    Milwaukee, Wisconsin, 53226

  • Regeneron Investigational Site

    Mineola, New York, 11501

  • Regeneron Investigational Site

    Mount Vernon, New York, 10552

  • Regeneron Investigational Site

    New Haven, Connecticut, 06519

  • Regeneron Investigational Site

    New York, New York, 10012-1354

  • Regeneron Investigational Site

    New York, New York, 10016

  • Regeneron Investigational Site

    New York, New York, 10029

  • Regeneron Investigational Site

    New York, New York, 10075

  • Regeneron Investigational Site

    Newport Beach, California, 92663

  • Regeneron Investigational Site

    Norfolk, Virginia, 23502

  • Regeneron Investigational Site

    North Charleston, South Carolina, 29420-4211

  • Regeneron Investigational Site

    Oceanside, California, 92056

  • Regeneron Investigational Site

    Overland Park, Kansas, 66215

  • Regeneron Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Regeneron Investigational Site

    Philadelphia, Pennsylvania, 19140

  • Regeneron Investigational Site

    Piscataway, New Jersey, 08854

  • Regeneron Investigational Site

    Plainfield, Indiana, 46168

  • Regeneron Investigational Site

    Portland, Oregon, 97239

  • Regeneron Investigational Site

    Quincy, Massachusetts, 02169

  • Regeneron Investigational Site

    Redondo Beach, California, 90277

  • Regeneron Investigational Site

    Riverside, California, 92506-0174

  • Regeneron Investigational Site

    Rockville, Maryland, 20850

  • Regeneron Investigational Site

    Roseville, California, 95661

  • Regeneron Investigational Site

    San Antonio, Texas, 78205

  • Regeneron Investigational Site

    San Diego, California, 92123

  • Regeneron Investigational Site

    Sandy Springs, Georgia, 30328

  • Regeneron Investigational Site

    Santa Monica, California, 90404

  • Regeneron Investigational Site

    Sellersville, Pennsylvania, 18960

  • Regeneron Investigational Site

    Skokie, Illinois, 60077

  • Regeneron Investigational Site

    Springfield, Illinois, 62604

  • Regeneron Investigational Site

    St Louis, Missouri, 63110

  • Regeneron Investigational Site

    Sugar Land, Texas, 77478

  • Regeneron Investigational Site

    Sugar Land, Texas, 77479

  • Regeneron Investigational Site

    The Bronx, New York, 10467-2401

  • Regeneron Investigational Site

    Thousand Oaks, California, 91320

  • Regeneron Investigational Site

    Towson, Maryland, 21204

  • Regeneron Investigational Site

    Troy, Michigan, 48084

  • Regeneron Investigational Site

    Troy, New York, 12180

  • Regeneron Investigational Site

    Tulsa, Oklahoma, 74136

  • Regeneron Investigational Site

    Upper Marlboro, Maryland, 20772

  • Regeneron Investigational Site

    Warren, Michigan, 48088

  • Regeneron Investigational Site

    West Palm Beach, Florida, 33406

  • Regeneron Investigational Site

    White Marsh, Maryland, 21162

  • Regeneron Investigational Site

    Yardley, Pennsylvania, 19067

Other trials in United States

Canada6 sites

  • Regeneron Investigational Site

    Hamilton, Ontario, L8L 8E7

  • Regeneron Investigational Site

    Markham, Ontario, L3P 1X2

  • Regeneron Investigational Site

    Ottawa, Ontario, K1G 6G6

  • Regeneron Investigational Site

    Peterborough, Ontario, K9J 5K2

  • Regeneron Investigational Site

    Québec, G1V 4X7

  • Regeneron Investigational Site

    Toronto, Ontario, M5G 1E2

Other trials in Canada

About this study

Official title: 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)

Read the 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

Being tested
Dupilumab
Keywords
Eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DupilumabDrug

    Also called DUPIXENT®, REGN668

    Dupixent 1 dose at Baseline required for eligibility; otherwise, no therapeutic intervention required during the course of the study. In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Registry Assessment: Baseline Characteristics

    Medical history

    Measured: At baseline (day when DUPIXENT treatment is initiated)

  2. Registry Assessment: Baseline Characteristic

    Socio-demographics

    Measured: At baseline (day when DUPIXENT treatment is initiated)

Secondary outcomes (20)

  1. Registry (Physician) Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis

    Percentage of BSA affected by AD assessed for each major section of the body

    Measured: Baseline to month 60

  2. Registry (Physician) Assessment: Eczema Area and Severity Index (EASI)

    Measure used in clinical practice and clinical trials to assess the severity and extent of AD

    Measured: Baseline to month 60

  3. Registry (Physician) Assessment: Overall Disease Severity scale

    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)

    Measured: Baseline to month 60

  4. Registry (Participant) Assessment: Patient Oriented Eczema Measure

    Questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults

    Measured: Baseline to month 60

  5. Registry (Participant) Assessment: Pruritus Numerical Rating Scales (NRS)

    Individual NRS used to rate the intensity of pruritus using a 0 to 10 numeric rating scale.

    Measured: Baseline to month 60

  6. Registry (Participant) Assessment: Skin Pain or Soreness NRS

    Individual NRS used to rate skin pain and soreness using a 0 to 10 NRS

    Measured: Baseline to month 60

  7. Registry (Participant) Assessment: Skin Feeling Hot NRS

    Individual NRS used to rate the sensation of skin feeling hot (burning sensation) using a 0 to 10 NRS

    Measured: Baseline to month 60

  8. Registry (Participant) Assessment: Skin Sensitivity NRS

    Individual NRS used to rate skin sensitivity using a 0 to 10 NRS

    Measured: Baseline to month 60

  9. Registry (Participant) Assessment: Sleep Disturbance NRS

    Individual NRS used to report the severity of their sleep disturbance using a 0 to 10 NRS

    Measured: Baseline to month 60

  10. Registry (Participant) Assessment: Global Assessment of Atopic Dermatitis scale

    Rate of overall well-being on a 5-point scale.

    Measured: Baseline to month 60

  11. Registry (Participant) Assessment: Dermatology Life Quality Index (DLQI)

    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

    Measured: Baseline to month 60

  12. Registry (Participant) Assessment: Children's Dermatology Life Quality Index (CDLQI)

    Questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on QOL in pediatrics.

    Measured: Baseline to month 60

  13. Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD)

    Questionnaire to assess the impact of AD on productivity.

    Measured: Baseline to month 60

  14. Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire

    Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD.

    Measured: Baseline to month 60

  15. Registry (Participant) Assessment: Dermatitis Family Impact Questionnaire

    Questionnaire to assess the impact of atopic eczema on the QOL of the parents and family members of affected children.

    Measured: Baseline to month 60

  16. Registry (Participant) Assessment: Missed School Days

    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.

    Measured: Baseline to month 60

  17. Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5)

    5-question version of questionnaire to evaluate asthma control in registry patients with comorbid asthma.

    Measured: Baseline to month 60

  18. Registry (Participant) Assessment: Allergic Rhinitis Visual Analog Scale (AR-VAS)

    Questionnaire used as a validated measuring instrument for the documentation of symptoms and therapy monitoring in AR.

    Measured: Baseline to month 60

  19. Registry (Participant) Assessment: Changes in Concurrent Conditions

    Rate of change in any other condition(s) (other than eczema, asthma, and allergic symptoms) on a 2-point scale (Better or Worse).

    Measured: Baseline to month 60

  20. Registry (Participant) Assessment: Overall Health State

    Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent).

    Measured: Baseline to month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2018
  2. Study start6 Apr 2018
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion28 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
858 participants (actual)
Target duration
60 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03428646
Sponsor's protocol ID
R668-AD-1762
Acronym
PROSE
Status last verified
Oct 2026
First submitted
13 Dec 2017
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bhatia N, Lynde CW, Fonacier L, Shao L, Bosman K, Korotzer A. Complete/Near-Complete Itch Response Observed in Patients with Moderate-to-Severe Atopic Dermatitis Initiating Dupilumab: 3-Year, Real-World, Interim Data from the PROSE Registry. Dermatol Ther (Heidelb). 2025 Jun;15(6):1523-1531. doi: 10.1007/s13555-025-01395-1. Epub 2025 Apr 15.

    PubMed 40234297

  • Simpson EL, Lockshin B, Lee LW, Chen Z, Daoud M, Korotzer A. Real-World Effectiveness of Dupilumab in Adult and Adolescent Patients with Atopic Dermatitis: 2-Year Interim Data from the PROSE Registry. Dermatol Ther (Heidelb). 2024 Jan;14(1):261-270. doi: 10.1007/s13555-023-01061-4. Epub 2024 Jan 4.

    PubMed 38175364

  • Bagel J, Nguyen TQ, Lima H, Jain N, Pariser DM, Hsu S, Yosipovitch G, Zhang H, Chao J, Bansal S, Chen Z, Richman D, Korotzer A, Ardeleanu M. Baseline Demographics and Severity and Burden of Atopic Dermatitis in Adult Patients Initiating Dupilumab Treatment in a Real-World Registry (PROSE). Dermatol Ther (Heidelb). 2022 Jun;12(6):1417-1430. doi: 10.1007/s13555-022-00742-w. Epub 2022 May 20.

    PubMed 35590038

Questions about this trial

What is this clinical trial studying?

An observational study of Dermatitis, Atopic, run by Regeneron Pharmaceuticals at 99 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Registry Assessment: Baseline Characteristics (time frame: At baseline (day when DUPIXENT treatment is initiated)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03428646, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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