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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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A long-term observational registry in patients with atopic dermatitis (AD) initiating treatment with DUPIXENT® (dupilumab)
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Registry Assessment: Baseline Characteristics | Medical history | At baseline (day when DUPIXENT treatment is initiated) |
| Registry Assessment: Baseline Characteristic | Socio-demographics | At baseline (day when DUPIXENT treatment is initiated) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to month 60 |
| Registry (Physician) Assessment: Eczema Area and Severity Index (EASI) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| Regeneron Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40234297 | Derived | 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. | |
| 38175364 |
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Optional sub-study: Blood samples will be collected and stored up to 10 years for future use in bio-marker research. Participants who agree to provide blood samples for future research will be required to sign a separate informed consent form (ICF) before collection of the samples.
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 | 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 | 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) | 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 | 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 | 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 | Individual NRS used to rate skin sensitivity using a 0 to 10 NRS | Baseline to month 60 |
| Registry (Participant) Assessment: Sleep Disturbance NRS | 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 | Rate of overall well-being on a 5-point scale. | Baseline to month 60 |
| 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 | Baseline to month 60 |
| 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. | Baseline to month 60 |
| Registry (Participant) Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) | Questionnaire to assess the impact of AD on productivity. | Baseline to month 60 |
| Registry (Participant) Assessment: Health Care Resource Utilization Questionnaire | Questionnaire regarding hospitalization, or emergency room/ urgent care center visits due to AD. | Baseline to month 60 |
| 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. | Baseline to month 60 |
| 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. | Baseline to month 60 |
| Registry (Participant) Assessment: Juniper Asthma Control Questionnaire (ACQ-5) | 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) | 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 | 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 | Rate of overall state of health on a 5-point scale (Poor, Fair, Good, Very Good or Excellent). | Baseline to month 60 |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Regeneron Investigational Site | Fountain Valley | California | 92708 | United States |
| Regeneron Investigational Site | Laguna Hills | California | 92653 | United States |
| Regeneron Investigational Site | Loma Linda | California | 92354 | United States |
| Regeneron Investigational Site | Los Angeles | California | 90025 | United States |
| Regeneron Investigational Site | Los Angeles | California | 90067 | United States |
| Regeneron Investigational Site | Manhattan Beach | California | 90266-2911 | United States |
| Regeneron Investigational Site | Newport Beach | California | 92663 | United States |
| Regeneron Investigational Site | Oceanside | California | 92056 | United States |
| Regeneron Investigational Site | Redondo Beach | California | 90277 | United States |
| Regeneron Investigational Site | Riverside | California | 92506-0174 | United States |
| Regeneron Investigational Site | Roseville | California | 95661 | United States |
| Regeneron Investigational Site | San Diego | California | 92123 | United States |
| Regeneron Investigational Site | Santa Monica | California | 90404 | United States |
| Regeneron Investigational Site | Thousand Oaks | California | 91320 | United States |
| Regeneron Investigational Site | New Haven | Connecticut | 06519 | United States |
| Regeneron Investigational Site | Coral Gables | Florida | 33146 | United States |
| Regeneron Investigational Site | Margate | Florida | 33063 | United States |
| Regeneron Investigational Site | West Palm Beach | Florida | 33406 | United States |
| Regeneron Investigational Site | Atlanta | Georgia | 30342-1703 | United States |
| Regeneron Investigational Site | Macon | Georgia | 31217 | United States |
| Regeneron Investigational Site | Marietta | Georgia | 30060-1047 | United States |
| Regeneron Investigational Site | Marietta | Georgia | 30152 | United States |
| Regeneron Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Regeneron Investigational Site | Champaign | Illinois | 61820 | United States |
| Regeneron Investigational Site | Chicago | Illinois | 60654 | United States |
| Regeneron Investigational Site | La Grange Park | Illinois | 60526 | United States |
| Regeneron Investigational Site | Skokie | Illinois | 60077 | United States |
| Regeneron Investigational Site | Springfield | Illinois | 62604 | United States |
| Regeneron Investigational Site | Fort Wayne | Indiana | 46804 | United States |
| Regeneron Investigational Site | Plainfield | Indiana | 46168 | United States |
| Regeneron Investigational Site | Overland Park | Kansas | 66215 | United States |
| Regeneron Investigational Site | Corbin | Kentucky | 40701 | United States |
| Regeneron Investigational Site | Louisville | Kentucky | 40202 | United States |
| Regeneron Investigational Site | Rockville | Maryland | 20850 | United States |
| Regeneron Investigational Site | Towson | Maryland | 21204 | United States |
| Regeneron Investigational Site | Upper Marlboro | Maryland | 20772 | United States |
| Regeneron Investigational Site | White Marsh | Maryland | 21162 | United States |
| Regeneron Investigational Site | Quincy | Massachusetts | 02169 | United States |
| Regeneron Investigational Site | Ann Arbor | Michigan | 48103 | United States |
| Regeneron Investigational Site | Bay City | Michigan | 48706 | United States |
| Regeneron Investigational Site | Troy | Michigan | 48084 | United States |
| Regeneron Investigational Site | Warren | Michigan | 48088 | United States |
| Regeneron Investigational Site | Columbia | Missouri | 65212-0001 | United States |
| Regeneron Investigational Site | Kirksville | Missouri | 63501 | United States |
| Regeneron Investigational Site | St Louis | Missouri | 63110 | United States |
| Regeneron Investigational Site | Lincoln | Nebraska | 68505 | United States |
| Regeneron Investigational Site | Henderson | Nevada | 89052 | United States |
| Regeneron Investigational Site | Las Vegas | Nevada | 89144 | United States |
| Regeneron Investigational Site | Brick | New Jersey | 08724 | United States |
| Regeneron Investigational Site | East Windsor | New Jersey | 08520 | United States |
| Regeneron Investigational Site | Edison | New Jersey | 08820 | United States |
| Regeneron Investigational Site | Piscataway | New Jersey | 08854 | United States |
| Regeneron Investigational Site | Elmhurst | New York | 11373-4831 | United States |
| Regeneron Investigational Site | Forest Hills | New York | 11374 | United States |
| Regeneron Investigational Site | Garden City | New York | 11530 | United States |
| Regeneron Investigational Site | Kew Gardens | New York | 11374 | United States |
| Regeneron Investigational Site | Lake Success | New York | 11042 | United States |
| Regeneron Investigational Site | Manhasset | New York | 11030 | United States |
| Regeneron Investigational Site | Mineola | New York | 11501 | United States |
| Regeneron Investigational Site | Mount Vernon | New York | 10552 | United States |
| Regeneron Investigational Site | New York | New York | 10012-1354 | United States |
| Regeneron Investigational Site | New York | New York | 10016 | United States |
| Regeneron Investigational Site | New York | New York | 10029 | United States |
| Regeneron Investigational Site | New York | New York | 10075 | United States |
| Regeneron Investigational Site | The Bronx | New York | 10467-2401 | United States |
| Regeneron Investigational Site | Troy | New York | 12180 | United States |
| Regeneron Investigational Site | Concord | North Carolina | 28025 | United States |
| Regeneron Investigational Site | Akron | Ohio | 44333 | United States |
| Regeneron Investigational Site | Athens | Ohio | 45701 | United States |
| Regeneron Investigational Site | Bexley | Ohio | 43209 | United States |
| Regeneron Investigational Site | Marion | Ohio | 43302 | United States |
| Regeneron Investigational Site | Mason | Ohio | 45040 | United States |
| Regeneron Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Regeneron Investigational Site | Portland | Oregon | 97239 | United States |
| Regeneron Investigational Site | Blue Bell | Pennsylvania | 19422 | United States |
| Regeneron Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Regeneron Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Regeneron Investigational Site | Sellersville | Pennsylvania | 18960 | United States |
| Regeneron Investigational Site | Yardley | Pennsylvania | 19067 | United States |
| Regeneron Investigational Site | Charleston | South Carolina | 29425 | United States |
| Regeneron Investigational Site | North Charleston | South Carolina | 29420-4211 | United States |
| Regeneron Investigational Site | Bellaire | Texas | 77401 | United States |
| Regeneron Investigational Site | Dallas | Texas | 75231 | United States |
| Regeneron Investigational Site | Grapevine | Texas | 76051 | United States |
| Regeneron Investigational Site | San Antonio | Texas | 78205 | United States |
| Regeneron Investigational Site | Sugar Land | Texas | 77478 | United States |
| Regeneron Investigational Site | Sugar Land | Texas | 77479 | United States |
| Regeneron Investigational Site | Arlington | Virginia | 22204 | United States |
| Regeneron Investigational Site | Norfolk | Virginia | 23502 | United States |
| Regeneron Investigational Site | Bellevue | Washington | 98004 | United States |
| Regeneron Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| Regeneron Investigational Site | Hamilton | Ontario | L8L 8E7 | Canada |
| Regeneron Investigational Site | Markham | Ontario | L3P 1X2 | Canada |
| Regeneron Investigational Site | Ottawa | Ontario | K1G 6G6 | Canada |
| Regeneron Investigational Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Regeneron Investigational Site | Toronto | Ontario | M5G 1E2 | Canada |
| Regeneron Investigational Site | Québec | G1V 4X7 | Canada |
| 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. |
| 35590038 | Derived | 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. |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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