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

NCT ID: NCT03428646

Last Updated: 2025-12-29

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

ACTIVE_NOT_RECRUITING

Total Enrollment

858 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-06

Study Completion Date

2027-03-30

Brief Summary

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

Detailed Description

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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

Conditions

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Dermatitis, Atopic

Keywords

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Eczema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Dupilumab

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.

Intervention Type DRUG

Other Intervention Names

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DUPIXENT® REGN668

Eligibility Criteria

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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.

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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Affairs

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Birmingham, Alabama, United States

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Gilbert, Arizona, United States

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Fountain Valley, California, United States

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Laguna Hills, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Manhattan Beach, California, United States

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Newport Beach, California, United States

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Oceanside, California, United States

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Redondo Beach, California, United States

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Riverside, California, United States

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Roseville, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Thousand Oaks, California, United States

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New Haven, Connecticut, United States

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Coral Gables, Florida, United States

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Margate, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Marietta, Georgia, United States

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Sandy Springs, Georgia, United States

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Champaign, Illinois, United States

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Chicago, Illinois, United States

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La Grange Park, Illinois, United States

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Skokie, Illinois, United States

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Springfield, Illinois, United States

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Fort Wayne, Indiana, United States

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Plainfield, Indiana, United States

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Overland Park, Kansas, United States

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Corbin, Kentucky, United States

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Louisville, Kentucky, United States

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Rockville, Maryland, United States

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Towson, Maryland, United States

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Upper Marlboro, Maryland, United States

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White Marsh, Maryland, United States

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Quincy, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Bay City, Michigan, United States

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Troy, Michigan, United States

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Warren, Michigan, United States

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Columbia, Missouri, United States

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Kirksville, Missouri, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Brick, New Jersey, United States

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East Windsor, New Jersey, United States

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Edison, New Jersey, United States

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Piscataway, New Jersey, United States

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Elmhurst, New York, United States

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Forest Hills, New York, United States

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Garden City, New York, United States

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Kew Gardens, New York, United States

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Lake Success, New York, United States

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Manhasset, New York, United States

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Mineola, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Troy, New York, United States

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Concord, North Carolina, United States

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Akron, Ohio, United States

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Athens, Ohio, United States

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Bexley, Ohio, United States

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Marion, Ohio, United States

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Mason, Ohio, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Blue Bell, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Charleston, South Carolina, United States

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North Charleston, South Carolina, United States

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Bellaire, Texas, United States

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Dallas, Texas, United States

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Grapevine, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Sugar Land, Texas, United States

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Arlington, Virginia, United States

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Norfolk, Virginia, United States

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Bellevue, Washington, United States

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Milwaukee, Wisconsin, United States

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Hamilton, Ontario, Canada

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Markham, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, , Canada

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Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 40234297 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38175364 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35590038 (View on PubMed)

Other Identifiers

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R668-AD-1762

Identifier Type: -

Identifier Source: org_study_id