Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001449-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The primary objective is to assess the long-term safety of dupilumab administered in adult participants with atopic dermatitis (AD).
The secondary objective of the study is to assess the immunogenicity of dupilumab in adult participants with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.
Optional Sub-Study:
The primary objective of the sub-study is to assess the safety of the new dupilumab drug product in adult patients with AD after switching from the current dupilumab drug product.
The secondary objectives of the sub-study are to evaluate systemic exposure and immunogenicity of the new dupilumab drug product in adult patients with AD.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dupilumab | Experimental | Participants will receive repeat doses of dupilumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) | Up to 272 weeks | |
| OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | Up to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Serious Adverse Events (SAEs) of Special Interest | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | Up to 272 weeks |
Not provided
Key Inclusion Criteria:
Participation in a prior clinical trial of dupilumab for AD and met one of the following:
Willing and able to comply with all clinic visits and study-related procedures
Able to understand and complete study-related questionnaires
Provide signed informed consent
Optional Sub-Study:
Key Exclusion Criteria:
Patients who, during their participation in a previous dupilumab clinical trial, developed a serious adverse event (SAE) deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Patients who, during their participation in a previous dupilumab clinical trial, developed an AE that was deemed related to dupilumab* and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
Conditions in the previous dupilumab study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to dupilumab* or led to investigator - or sponsor-initiated withdrawal of patient from the study (eg, non-compliance, inability to complete study assessments, etc.).
*Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to dupilumab.
Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
Pregnant or breastfeeding women, or planning to become pregnant or breastfeed during the patient's participation in this study
Optional Sub-Study:
1. Patients who have already completed the end of treatment visit (ie, visit 44) for the main study R668-AD-1225
Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Study Site | Anniston | Alabama | 36207 | United States | ||
| Regeneron Study Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41999446 | Derived | Beck LA, Simpson EL, Thaci D, de Bruin-Weller M, Deleuran M, Kataoka Y, Blauvelt A, Wollenberg A, Eichenfield LF, Khokhar FA, Coleman A, Van Spall M, Ma Y, Avetisova E, Zhang A, Nguyen TV. Long-Term Dupilumab Treatment Is Not Associated with an Increased Overall Risk of Infections in Adults with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label 5-Year Extension Study. Adv Ther. 2026 Apr 18. doi: 10.1007/s12325-026-03582-8. Online ahead of print. | |
| 41563707 |
Not provided
Not provided
A total of 1297 participants completed the study and 1380 participants had withdrawn. Withdrawal from study included study terminated by the Sponsor (708), and withdrawal by the participant (375), Adverse Event (107), Lost to Follow-Up (73), Lack of Efficacy (50), Protocol Deviation (34), Pregnancy (20), Physician Decision (9), and reasons not specified (4)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dupilumab | Participants received repeated doses of dupilumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2021 | Jun 23, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Rate of AESIs | Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | Up to 272 weeks |
| Number of AESIs | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | Up to 272 weeks |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) |
| Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
| Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit | Low disease activity state is defined as an IGA score of ≤2 [mild = 2, almost clear = 1, or clear = 0] | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
| Change From Baseline in EASI Score at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
| Percent Change From Baseline in EASI Score at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
| Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | EASI-50 was defined as >=50% reduction in EASI scores from baseline of the parent study | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
| Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | EASI-90 was defined as >=90% reduction in EASI scores from baseline of the parent study | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
| Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
| Percent Change From Baseline in Pruritus NRS | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
| Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
| Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
| Percentage of Participants Requiring Rescue Treatment: Overall | Up to 272 weeks |
| Percentage of Participants Requiring Rescue Treatment: Systemic Treatment | Up to 272 weeks |
| Percentage of Participants Requiring Rescue Treatment: Phototherapy | Up to 272 weeks |
| Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI) | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL | Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)" |
| Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM) | The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL. | Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)" |
| Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D) | The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized measure of health status developed by the EuroQOL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The minimum value for the single index utility score is -0.594 (Best imaginable health state) and the maximum value for the single index utility score is 1 (Worst imaginable health state). | Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)" |
| OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product | Up to week 12 |
| OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product | For participants receiving dupilumab from a new manufacturing process, ADA baseline was defined as the baseline visit in the sub-study, or at the end of the main study, dependent on available data. | Up to 24 Weeks |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Regeneron Study Site 1 | Birmingham | Alabama | 35209 | United States |
| Regeneron Study Site 2 | Birmingham | Alabama | 35233 | United States |
| Regeneron Study Site 2 | Phoenix | Arizona | 85018 | United States |
| Regeneron Study Site 3 | Phoenix | Arizona | 85023 | United States |
| Regeneron Study Site 1 | Phoenix | Arizona | 85032 | United States |
| Regeneron Study Site | Fort Smith | Arkansas | 72916 | United States |
| Regeneron Study Site | Rogers | Arkansas | 72758 | United States |
| Regeneron Study Site | Bakersfield | California | 93309 | United States |
| Regeneron Study Site | Clovis | California | 93612 | United States |
| Regeneron Study Site | Costa Mesa | California | 92626 | United States |
| Regeneron Study Site | Encinitas | California | 92024 | United States |
| Regeneron Study Site | Fremont | California | 94538 | United States |
| Regeneron Study Site | Lomita | California | 90717 | United States |
| Regeneron Study Site | Long Beach | California | 90808 | United States |
| Regeneron Study Site 1 | Los Angeles | California | 90025 | United States |
| Regeneron Study Site 2 | Los Angeles | California | 90025 | United States |
| Regeneron Study Site | Los Angeles | California | 90045 | United States |
| Regeneron Study Site | Oceanside | California | 92056 | United States |
| Regeneron Study Site | Orange | California | 92868 | United States |
| Regeneron Study Site | Rolling Hills Estates | California | 90274 | United States |
| Regeneron Study Site | San Diego | California | 92122 | United States |
| Regeneron Study Site 1 | San Diego | California | 92123 | United States |
| Regeneron Study Site 2 | San Diego | California | 92123 | United States |
| Regeneron Study Site | Santa Monica | California | 90404 | United States |
| Regeneron Study Site | Centennial | Colorado | 80112 | United States |
| Regeneron Study Site | Denver | Colorado | 80206 | United States |
| Regeneron Study Site | Denver | Colorado | 80220 | United States |
| Regeneron Study Site | Trumbull | Connecticut | 06611 | United States |
| Regeneron Study Site | Washington D.C. | District of Columbia | 20037 | United States |
| Regeneron Study Site | Boca Raton | Florida | 33486 | United States |
| Regeneron Study Site | Clearwater | Florida | 33756 | United States |
| Regeneron Study Site | Fort Lauderdale | Florida | 33306 | United States |
| Regeneron Study Site 1 | Jacksonville | Florida | 32216 | United States |
| Regeneron Study Site 2 | Jacksonville | Florida | 32216 | United States |
| Regeneron Study Site | Lake Worth | Florida | 33461 | United States |
| Regeneron Study Site | Miami | Florida | 33135 | United States |
| Regeneron Study Site | Miami | Florida | 33144 | United States |
| Regeneron Study Site | Miami Lakes | Florida | 33016 | United States |
| Regeneron Study Site | Orlando | Florida | 32806 | United States |
| Regeneron Study Site | Tampa | Florida | 33607 | United States |
| Regeneron Study Site | Tampa | Florida | 33614 | United States |
| Regeneron Study Site | Tampa | Florida | 33624 | United States |
| Regeneron Study Site | West Palm Beach | Florida | 33406 | United States |
| Regeneron Study Site | Alpharetta | Georgia | 30022 | United States |
| Regeneron Study Site | Atlanta | Georgia | 30322 | United States |
| Regeneron Study Site | Columbus | Georgia | 31904 | United States |
| Regeneron Study Site | Macon | Georgia | 31217 | United States |
| Regeneron Study Site | Newnan | Georgia | 30263 | United States |
| Regeneron Study Site | Sandy Springs | Georgia | 30328 | United States |
| Regeneron Study Site | Savannah | Georgia | 31405 | United States |
| Regeneron Study Site | Chicago | Illinois | 60611 | United States |
| Regeneron Study Site | Normal | Illinois | 61761 | United States |
| Regeneron Study Site | West Dundee | Illinois | 60118 | United States |
| Regeneron Study Site | Indianapolis | Indiana | 46250 | United States |
| Regeneron Study Site | Newburgh | Indiana | 47630 | United States |
| Regeneron Study Site | Plainfield | Indiana | 46168 | United States |
| Regeneron Study Site | Overland Park | Kansas | 66215 | United States |
| Regeneron Study Site | New Orleans | Louisiana | 70112 | United States |
| Regeneron Study Site | Rockville | Maryland | 20850 | United States |
| Regeneron Study Site | Boston | Massachusetts | 02111 | United States |
| Regeneron Study Site | Boston | Massachusetts | 02114 | United States |
| Regeneron Study Site | Boston | Massachusetts | 02115 | United States |
| Regeneron Study Site | Bay City | Michigan | 48706 | United States |
| Regeneron Study Site | Farmington Hills | Michigan | 48334 | United States |
| Regeneron Study Site | Troy | Michigan | 48084 | United States |
| Regeneron Study Site | Edina | Minnesota | 55435 | United States |
| Regeneron Study Site | Fridley | Minnesota | 55432 | United States |
| Regeneron Study Site | Minneapolis | Minnesota | 55402 | United States |
| Regeneron Study Site | Plymouth | Minnesota | 55402 | United States |
| Regeneron Study Site | Saint Joseph | Missouri | 64506 | United States |
| Regeneron Study Site | St Louis | Missouri | 63104 | United States |
| Regeneron Study Site | St Louis | Missouri | 63141 | United States |
| Regeneron Study Site | Henderson | Nevada | 89052 | United States |
| Regeneron Study Site | Las Vegas | Nevada | 89119 | United States |
| Regeneron Study Site | Portsmouth | New Hampshire | 03801 | United States |
| Regeneron Study Site | Berlin | New Jersey | 08009 | United States |
| Regeneron Study Site | East Windsor | New Jersey | 08520 | United States |
| Regeneron Study Site | Verona | New Jersey | 07044-2946 | United States |
| Regeneron Study Site 1 | Albuquerque | New Mexico | 87106 | United States |
| Regeneron Study Site 2 | Albuquerque | New Mexico | 87106 | United States |
| Regeneron Study Site | Buffalo | New York | 14203 | United States |
| Regeneron Study Site | Corning | New York | 14830 | United States |
| Regeneron Study Site | Forest Hills | New York | 11375 | United States |
| Regeneron Study Site | New York | New York | 10016 | United States |
| Regeneron Study Site | New York | New York | 10021 | United States |
| Regeneron Study Site | New York | New York | 10029-6501 | United States |
| Regeneron Study Site | New York | New York | 10075 | United States |
| Regeneron Study Site | Rochester | New York | 14642 | United States |
| Regeneron Study Site | Chapel Hill | North Carolina | 27516 | United States |
| Regeneron Study Site | High Point | North Carolina | 27262 | United States |
| Regeneron Study Site | Raleigh | North Carolina | 27612 | United States |
| Regeneron Study Site | Wilmington | North Carolina | 28405 | United States |
| Regeneron Study Site | Winston-Salem | North Carolina | 27104 | United States |
| Regeneron Study Site | Cincinnati | Ohio | 45231 | United States |
| Regeneron Study Site | Cleveland | Ohio | 44106 | United States |
| Regeneron Study Site | Norman | Oklahoma | 73071 | United States |
| Regeneron Study Site | Tulsa | Oklahoma | 74136 | United States |
| Regeneron Study Site | Medford | Oregon | 97504-9741 | United States |
| Regeneron Study Site | Portland | Oregon | 97223 | United States |
| Regeneron Study Site | Portland | Oregon | 97239 | United States |
| Regeneron Study Site | Bethlehem | Pennsylvania | 18020 | United States |
| Regeneron Study Site | Jenkintown | Pennsylvania | 19046 | United States |
| Regeneron Study Site | Philadelphia | Pennsylvania | 19104 | United States |
| Regeneron Study Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Regeneron Study Site | Charleston | South Carolina | 29407 | United States |
| Regeneron Study Site | Greer | South Carolina | 29650 | United States |
| Regeneron Study Site | Chattanooga | Tennessee | 37421 | United States |
| Regeneron Study Site | Nashville | Tennessee | 37215 | United States |
| Regeneron Study Site | Arlington | Texas | 76011 | United States |
| Regeneron Study Site | Austin | Texas | 78705 | United States |
| Regeneron Study Site | Bellaire | Texas | 77401-3505 | United States |
| Regeneron Study Site | Dallas | Texas | 75230 | United States |
| Regeneron Study Site | Dallas | Texas | 75231 | United States |
| Regeneron Study Site | Dallas | Texas | 75246 | United States |
| Regeneron Study Site | Houston | Texas | 77004 | United States |
| Regeneron Study Site | San Antonio | Texas | 78218 | United States |
| Regeneron Study Site 1 | San Antonio | Texas | 78229 | United States |
| Regeneron Study Site 2 | San Antonio | Texas | 78229 | United States |
| Regeneron Study Site | San Antonio | Texas | 78258 | United States |
| Regeneron Study Site | Waco | Texas | 76710 | United States |
| Regeneron Study Site | Webster | Texas | 77598 | United States |
| Regeneron Study Site | Salt Lake City | Utah | 84132 | United States |
| Regeneron Study Site | South Burlington | Vermont | 05403 | United States |
| Regeneron Study Site | Newport News | Virginia | 23606-4537 | United States |
| Regeneron Study Site | Norfolk | Virginia | 23502 | United States |
| Regeneron Study Site | Richmond | Virginia | 23220 | United States |
| Regeneron Study Site | Seattle | Washington | 98101 | United States |
| Regeneron Study Site | Phillip | Australian Capital Territory | Australia |
| Regeneron Study Site | Kogarah | New South Wales | Australia |
| Regeneron Study Site | Benowa | Queensland | Australia |
| Regeneron Study Site | Woolloongabba | Queensland | Australia |
| Regeneron Study Site | Hectorville | South Australia | Australia |
| Regeneron Study Site | Carlton | Victoria | Australia |
| Regeneron Study Site | East Melbourne | Victoria | Australia |
| Regeneron Study Site | Fremantle | Western Australia | Australia |
| Regeneron Study Site 1 | Vienna | Austria |
| Regeneron Study Site 2 | Vienna | Austria |
| Regeneron Study Site | Brussels | Brussels Capital | Belgium |
| Regeneron Study Site | Loverval | Hainaut | Belgium |
| Regeneron Study Site | Leuven | Vlaams Brabant | Belgium |
| Regeneron Study Site | Dupnitsa | Kyustendil | Bulgaria |
| Regeneron Study Site 1 | Sofia | Sofia-Grad | Bulgaria |
| Regeneron Study Site 2 | Sofia | Sofia-Grad | Bulgaria |
| Regeneron Study Site 1 | Calgary | Alberta | Canada |
| Regeneron Study Site 2 | Calgary | Alberta | Canada |
| Regeneron Study Site 1 | Edmonton | Alberta | Canada |
| Regeneron Study Site 2 | Edmonton | Alberta | Canada |
| Regeneron Study Site 1 | Surrey | British Columbia | Canada |
| Regeneron Study Site 2 | Surrey | British Columbia | Canada |
| Regeneron Study Site 1 | Vancouver | British Columbia | Canada |
| Regeneron Study Site 2 | Vancouver | British Columbia | Canada |
| Regeneron Study Site 3 | Vancouver | British Columbia | Canada |
| Regeneron Study Site 1 | Winnipeg | Manitoba | Canada |
| Regeneron Study Site | Bathurst | New Brunswick | Canada |
| Regeneron Study Site | St. John's | Newfoundland and Labrador | Canada |
| Regeneron Study Site | Ajax | Ontario | Canada |
| Regeneron Study Site 1 | Barrie | Ontario | Canada |
| Regeneron Study Site 2 | Barrie | Ontario | Canada |
| Regeneron Study Site | Etobicoke | Ontario | Canada |
| Regeneron Study Site 1 | Hamilton | Ontario | Canada |
| Regeneron Study Site 2 | Hamilton | Ontario | Canada |
| Regeneron Study Site | Markham | Ontario | Canada |
| Regeneron Study Site | Mississauga | Ontario | Canada |
| Regeneron Study Site | Newmarket | Ontario | Canada |
| Regeneron Study Site | North Bay | Ontario | Canada |
| Regeneron Study Site | Oakville | Ontario | Canada |
| Regeneron Study Site 1 | Ottawa | Ontario | Canada |
| Regeneron Study Site | Peterborough | Ontario | Canada |
| Regeneron Study Site 1 | Richmond Hill | Ontario | Canada |
| Regeneron Study Site 2 | Richmond Hill | Ontario | Canada |
| Regeneron Study Site | Toronto | Ontario | Canada |
| Regeneron Study Site | Waterloo | Ontario | Canada |
| Regeneron Study Site 1 | Windsor | Ontario | Canada |
| Regeneron Study Site 2 | Windsor | Ontario | Canada |
| Regeneron Study Site | Drummondville | Quebec | Canada |
| Regeneron Study Site | Montreal | Quebec | Canada |
| Regeneron Study Site 3 | Ste-Foy | Quebec | Canada |
| Regeneron Study Site | Ste-Foy | Canada |
| Regeneron Study Site | Winnipeg | Canada |
| Regeneron Study Site | Hong Kong | China |
| Regeneron Study Site | Hradec Králové | Czechia |
| Regeneron Study Site | Kutná Hora | Czechia |
| Regeneron Study Site | Náchod | Czechia |
| Regeneron Study Site | Prague | Czechia |
| Regeneron Study Site | Svitavy | Czechia |
| Regeneron Study Site | Ústí nad Labem | Czechia |
| Regeneron Study Site | Copenhagen | Capital | Denmark |
| Regeneron Study Site | Hellerup | Capital | Denmark |
| Regeneron Study Site | Aarhus | Central Jutland | Denmark |
| Regeneron Study Site | Roskilde | Region Sjælland | Denmark |
| Regeneron Study Site 1 | Tallinn | Harju | Estonia |
| Regeneron Study Site 2 | Tallinn | Harju | Estonia |
| Regeneron Study Site 3 | Tallinn | Harju | Estonia |
| Regeneron Study Site 1 | Tartu | Tartu | Estonia |
| Regeneron Study Site 2 | Tartu | Tartu | Estonia |
| Regeneron Study Site | Helsinki | Etelä-Suomen Iääni | Finland |
| Regeneron Study Site | Turku | Etelä-Suomen Lääni | Finland |
| Regeneron Study Site | Tampere | Länsi-Suomen Lääni | Finland |
| Regeneron Study Site | Nice | Alpes-Maritimes | France |
| Regeneron Study Site | Pierre-Bénite | Auvergne-Rhône-Alpes | France |
| Regeneron Study Site | Marseille | Bouches-du-Rhône | France |
| Regeneron Study Site | Reims | Marne | France |
| Regeneron Study Site | Lille | Nord | France |
| Regeneron Study Site | Lille | France |
| Regeneron Study Site | Nantes | France |
| Regeneron Study Site | Paris | Île-de-France Region | France |
| Regeneron Study Site | Friedrichshafen | Baden-Wurttemberg | Germany |
| Regeneron Study Site | Heidelberg | Baden-Wurttemberg | Germany |
| Regeneron Study Site | Langenau | Baden-Wurttemberg | Germany |
| Regeneron Study Site | Stuttgart | Baden-Wurttemberg | Germany |
| Regeneron Study Site | Tübingen | Baden-Wurttemberg | Germany |
| Regeneron Study Site | Augsburg | Bavaria | Germany |
| Regeneron Study Site | Erlangen | Bavaria | Germany |
| Regeneron Study Site | Munich | Bavaria | Germany |
| Regeneron Study Site | München | Bavaria | Germany |
| Regeneron Study Site | Mahlow | Brandenburg | Germany |
| Regeneron Study Site 2 | Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Regeneron Study Site | Frankfurt am Main | Hesse | Germany |
| Regeneron Study Site | Hanover | Lower Saxony | Germany |
| Regeneron Study Site | Schwerin | Mecklenburg-Vorpommern | Germany |
| Regeneron Study Site 1 | Bochum | North Rhine-Westphalia | Germany |
| Regeneron Study Site 2 | Bochum | North Rhine-Westphalia | Germany |
| Regeneron Study Site | Dülmen | North Rhine-Westphalia | Germany |
| Regeneron Study Site | Ibbenbueren | North Rhine-Westphalia | Germany |
| Regeneron Study Site | Mönchengladbach | North Rhine-Westphalia | Germany |
| Regeneron Study Site | Münster | North Rhine-Westphalia | Germany |
| Regeneron Study Site | Mainz | Rhineland-Palatinate | Germany |
| Regeneron Study Site | Selters | Rhineland-Palatinate | Germany |
| Regeneron Study Site 1 | Dresden | Saxony | Germany |
| Regeneron Study Site 2 | Dresden | Saxony | Germany |
| Regeneron Study Site 3 | Dresden | Saxony | Germany |
| Regeneron Study Site | Leipzig | Saxony | Germany |
| Regeneron Study Site | Halle | Saxony-Anhalt | Germany |
| Regeneron Study Site | Magdeburg | Saxony-Anhalt | Germany |
| Regeneron Study Site 1 | Kiel | Schleswig-Holstein | Germany |
| Regeneron Study Site 2 | Kiel | Schleswig-Holstein | Germany |
| Regeneron Study Site | Lübeck | Schleswig-Holstein | Germany |
| Regeneron Study Site | Gera | Thuringia | Germany |
| Regeneron Study Site 1 | Berlin | Germany |
| Regeneron Study Site 2 | Berlin | Germany |
| Regeneron Study Site 3 | Berlin | Germany |
| Regeneron Study Site 4 | Berlin | Germany |
| Regeneron Study Site 5 | Berlin | Germany |
| Regeneron Study Site 6 | Berlin | Germany |
| Regeneron Study Site 7 | Berlin | Germany |
| Regeneron Study Site | Bonn | Germany |
| Regeneron Study Site | Darmstadt | Germany |
| Regeneron Study Site 1 | Hamburg | Germany |
| Regeneron Study Site | Münster | Germany |
| Regeneron Study Site | Osnabrück | Germany |
| Regeneron Study Site | Orosháza | Bekes County | Hungary |
| Regeneron Study Site | Sátoraljaújhely | Borsod-Abauj Zemplen county | Hungary |
| Regeneron Study Site | Szeged | Csongrád megye | Hungary |
| Regeneron Study Site | Szolnok | Jász-Nagykun-Szolnok | Hungary |
| Regeneron Study Site | Kaposvár | Somogy County | Hungary |
| Regeneron Study Site 1 | Budapest | Hungary |
| Regeneron Study Site 2 | Budapest | Hungary |
| Regeneron Study Site 3 | Budapest | Hungary |
| Regeneron Study Site | Veszprém | Hungary |
| Regeneron Study Site | Dublin | Ireland |
| Regeneron Study Site | Bologna | Balogna | Italy |
| Regeneron Study Site | Ancona | Italy |
| Regeneron Study Site | Chieti | Italy |
| Regeneron Study Site | Florence | Italy |
| Regeneron Study Site | Lucca | Italy |
| Regeneron Study Site | L’Aquila | Italy |
| Regeneron Study Site | Messina | Italy |
| Regeneron Study Site | Milan | Italy |
| Regeneron Study Site | Novara | Italy |
| Regeneron Study Site | Pavia | Italy |
| Regeneron Study Site | Perugia | Italy |
| Regeneron Study Site | Pisa | Italy |
| Regeneron Study Site 1 | Roma | Italy |
| Regeneron Study Site 2 | Roma | Italy |
| Regeneron Study Site | Nagakute | Aichi-ken | Japan |
| Regeneron Study Site | Kurume | Fukuoka | Japan |
| Regeneron Study Site | Fukuyama | Hiroshima | Japan |
| Regeneron Study Site | Sapporo | Hokkaido | Japan |
| Regeneron Study Site 1 | Fukuoka | Hukuoka | Japan |
| Regeneron Study Site 2 | Fukuoka | Hukuoka | Japan |
| Regeneron Study Site | Kitakyushu | Hukuoka | Japan |
| Regeneron Study Site 1 | Amagasaki | Hyôgo | Japan |
| Regeneron Study Site 2 | Amagasaki | Hyôgo | Japan |
| Regeneron Study Site | Inashiki-gun | Ibaraki | Japan |
| Regeneron Study Site 1 | Yokohama | Kanagawa | Japan |
| Regeneron Study Site 2 | Yokohama | Kanagawa | Japan |
| Regeneron Study Site 3 | Yokohama | Kanagawa | Japan |
| Regeneron Study Site | Kamimashiki | Kumamoto | Japan |
| Regeneron Study Site | Habikino | Osaka | Japan |
| Regeneron Study Site | Neyagawa | Osaka | Japan |
| Regeneron Study Site | Sakai | Osaka | Japan |
| Regeneron Study Site | Takatsuki | Osaka | Japan |
| Regeneron Study Site | Hamamatsu | Shizuoka | Japan |
| Regeneron Study Site | Yaizu | Shizuoka | Japan |
| Regeneron Study Site 1 | Bunkyo-ku | Tokyo | Japan |
| Regeneron Study Site 2 | Bunkyo-ku | Tokyo | Japan |
| Regeneron Study Site 1 | Chiyoda-ku | Tokyo | Japan |
| Regeneron Study Site 2 | Chiyoda-ku | Tokyo | Japan |
| Regeneron Study Site | Chuo-ku | Tokyo | Japan |
| Regeneron Study Site | Koto-ku | Tokyo | Japan |
| Regeneron Study Site | Nakano-ku | Tokyo | Japan |
| Regeneron Study Site 1 | Nerima City | Tokyo | Japan |
| Regeneron Study Site 2 | Nerima City | Tokyo | Japan |
| Regeneron Study Site | Ōta-ku | Tokyo | Japan |
| Regeneron Study Site | Setagaya-ku | Tokyo | Japan |
| Regeneron Study Site 1 | Shibuya-ku | Tokyo | Japan |
| Regeneron Study Site 2 | Shibuya-ku | Tokyo | Japan |
| Regeneron Study Site 3 | Shibuya-ku | Tokyo | Japan |
| Regeneron Study Site 1 | Shinagawa-ku | Tokyo | Japan |
| Regeneron Study Site 2 | Shinagawa-ku | Tokyo | Japan |
| Regeneron Study Site 1 | Shinjuku-ku | Tokyo | Japan |
| Regeneron Study Site 2 | Shinjuku-ku | Tokyo | Japan |
| Regeneron Study Site 3 | Shinjuku-ku | Tokyo | Japan |
| Regeneron Study Site 4 | Shinjuku-ku | Tokyo | Japan |
| Regeneron Study Site 5 | Shinjuku-ku | Tokyo | Japan |
| Regeneron Study Site 6 | Shinjuku-ku | Tokyo | Japan |
| Regeneron Study Site 1 | Suginami | Tokyo | Japan |
| Regeneron Study Site 2 | Suginami | Tokyo | Japan |
| Regeneron Study Site | Chūō | Yamanashi | Japan |
| Regeneron Study Site | Kofu | Yamanashi | Japan |
| Regeneron Study Site 2 | Fukuyama | Japan |
| Regeneron Study Site | Gifu | Japan |
| Regeneron Study Site 1 | Hiroshima | Japan |
| Regeneron Study Site 2 | Hiroshima | Japan |
| Regeneron Study Site 1 | Kyoto | Japan |
| Regeneron Study Site 2 | Kyoto | Japan |
| Regeneron Study Site 1 | Osaka | Japan |
| Regeneron Study Site 2 | Osaka | Japan |
| Regeneron Study Site | Saitama | Japan |
| Regeneron Study Site 3 | Shinagawa-ku | Japan |
| Regeneron Study Site | Suginome | Japan |
| Regeneron Study Site | Wakayama | Japan |
| Regeneron Study Site 4 | Yokohama | Japan |
| Regeneron Study Site | Kaunas | Kaunas County | Lithuania |
| Regeneron Study Site 1 | Vilnius | Vilnius County | Lithuania |
| Regeneron Study Site 2 | Vilnius | Vilnius County | Lithuania |
| Regeneron Study Site 1 | Klaipėda | Lithuania |
| Regeneron Study Site 2 | Klaipėda | Lithuania |
| Regeneron Study Site | Breda | North Brabant | Netherlands |
| Regeneron Study Site | Amsterdam | North Holland | Netherlands |
| Regeneron Study Site | Rotterdam | South Holland | Netherlands |
| Regeneron Study Site | Groningen | Netherlands |
| Regeneron Study Site | Utrecht | Netherlands |
| Regeneron Study Site | Dunedin | South Island | New Zealand |
| Regeneron Study Site | Auckland | New Zealand |
| Regeneron Study Site 1 | Poznan | Greater Poland Voivodeship | Poland |
| Regeneron Study Site 2 | Poznan | Greater Poland Voivodeship | Poland |
| Regeneron Study Site 3 | Poznan | Greater Poland Voivodeship | Poland |
| Regeneron Study Site | Torun | Kuyavian-Pomeranian Voivodeship | Poland |
| Regeneron Study Site 1 | Krakow | Lesser Poland Voivodeship | Poland |
| Regeneron Study Site 2 | Krakow | Lesser Poland Voivodeship | Poland |
| Regeneron Study Site 3 | Krakow | Lesser Poland Voivodeship | Poland |
| Regeneron Study Site 1 | Wroclaw | Lower Silesian Voivodeship | Poland |
| Regeneron Study Site 2 | Wroclaw | Lower Silesian Voivodeship | Poland |
| Regeneron Study Site 3 | Wroclaw | Lower Silesian Voivodeship | Poland |
| Regeneron Study Site | Lublin | Lublin Voivodeship | Poland |
| Regeneron Study Site 1 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site 2 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site 3 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site 4 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site 5 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site 6 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site 7 | Warsaw | Masovian Voivodeship | Poland |
| Regeneron Study Site | Strzelce Opolskie | Opole Voivodeship | Poland |
| Regeneron Study Site | Iwonicz-Zdrój | Podkarpackie Voivodeship | Poland |
| Regeneron Study Site 1 | Gdansk | Pomeranian Voivodeship | Poland |
| Regeneron Study Site 2 | Gdansk | Pomeranian Voivodeship | Poland |
| Regeneron Study Site | Szczecin | West Pomeranian Voivodeship | Poland |
| Regeneron Study Site | Bialystok | Poland |
| Regeneron Study Site | Bydgoszcz | Poland |
| Regeneron Study Site | Chorzów | Poland |
| Regeneron Study Site | Elblag | 82300 | Poland |
| Regeneron Study Site 1 | Katowice | Poland |
| Regeneron Study Site 2 | Katowice | Poland |
| Regeneron Study Site 3 | Katowice | Poland |
| Regeneron Study Site | Ostrowiec Świętokrzyski | Poland |
| Regeneron Study Site | Skarżysko-Kamienna | Poland |
| Regeneron Study Site | Zgierz | 95100 | Poland |
| Regeneron Study Site 1 | Lodz | Łódź Voivodeship | Poland |
| Regeneron Study Site 2 | Lodz | Łódź Voivodeship | Poland |
| Regeneron Study Site 3 | Lodz | Łódź Voivodeship | Poland |
| Regeneron Study Site | Brasov | Romania |
| Regeneron Study Site | Moscow | Koskva | Russia |
| Regeneron Study Site | Ryazan | Ryazan Oblast | Russia |
| Regeneron Study Site | Saint Petersburg | Sankt-Peterburg | Russia |
| Regeneron Study Site | Kazan' | Tatarstan Respublika | Russia |
| Regeneron Study Site | Chelyabinsk | Russia |
| Regeneron Study Site 1 | Singapore | Central Singapore | Singapore |
| Regeneron Study Site 2 | Singapore | Central Singapore | Singapore |
| Regeneron Study Site | Singapore | South West | Singapore |
| Regeneron Study Site | Košice | Slovakia |
| Regeneron Study Site | Svidník | Slovakia |
| Regeneron Study Site | Busan | Busan Gwang'yeogsi | South Korea |
| Regeneron Study Site | Bucheon-si | Kyonggi-do | South Korea |
| Regeneron Study Site | Hwaseong-si | Kyonggi-do | South Korea |
| Regeneron Study Site | Suwon | Kyonggi-do | South Korea |
| Regeneron Study Site | Uijeongbu-si | Kyonggi-do | South Korea |
| Regeneron Study Site 1 | Incheon | South Korea |
| Regeneron Study Site 2 | Incheon | South Korea |
| Regeneron Study Site 1 | Seoul | South Korea |
| Regeneron Study Site 2 | Seoul | South Korea |
| Regeneron Study Site 3 | Seoul | South Korea |
| Regeneron Study Site 4 | Seoul | South Korea |
| Regeneron Study Site 5 | Seoul | South Korea |
| Regeneron Study Site 6 | Seoul | South Korea |
| Regeneron Study Site 7 | Seoul | South Korea |
| Regeneron Study Site 8 | Seoul | South Korea |
| Regeneron Study Site | Elche | Alicante | Spain |
| Regeneron Study Site | Badalona | Barcelona | Spain |
| Regeneron Study Site | Las Palmas de Gran Canaria | Canary Islands | Spain |
| Regeneron Study Site 1 | Barcelona | Spain |
| Regeneron Study Site 2 | Barcelona | Spain |
| Regeneron Study Site 3 | Barcelona | Spain |
| Regeneron Study Site 4 | Barcelona | Spain |
| Regeneron Study Site 1 | Madrid | Spain |
| Regeneron Study Site 2 | Madrid | Spain |
| Regeneron Study Site | Seville | Spain |
| Regeneron Study Site | Dundee | Angus | United Kingdom |
| Regeneron Study Site | Edgbaston | Birmingham | United Kingdom |
| Regeneron Study Site | Plymouth | Devon | United Kingdom |
| Regeneron Study Site | Portsmouth | Hampshire | United Kingdom |
| Regeneron Study Site | Sidcup | Kent | United Kingdom |
| Regeneron Study Site | Northwood | London | United Kingdom |
| Regeneron Study Site | Oxford | Oxfordshire | United Kingdom |
| Regeneron Study Site | Liverpool | United Kingdom |
| Regeneron Study Site 1 | London | United Kingdom |
| Regeneron Study Site 2 | London | United Kingdom |
| Regeneron Study Site | Manchester | United Kingdom |
| Regeneron Study Site | Salford | United Kingdom |
| Regeneron Study Site | Sheffield | United Kingdom |
| Derived |
| Simpson EL, Bissonnette R, Deleuran M, Nakahara T, Galus R, de Bruin-Weller M, Coleman A, van Spall M, Chen Z, Avetisova E, Bastian M, Khokhar FA. Dupilumab Treatment Up to 5 Years Shows No Clinically Meaningful Changes in Laboratory Parameters in Adults with Moderate-to-Severe Atopic Dermatitis. Adv Ther. 2026 Mar;43(3):1213-1238. doi: 10.1007/s12325-025-03458-3. Epub 2026 Jan 21. |
| 39588375 | Derived | Kamal MA, Kosloski MP, Lai CH, Partridge MA, Rajadhyaksha M, Kanamaluru V, Bansal A, Shabbir A, Shumel B, Ardeleanu M, Richards SM, Yan H, Xu CR, Rodriguez-Marco A, Xiao J, Khokhar FA, Gherardi G, Babilonia E, Maloney J, Mortensen E, Akinlade B, Braunstein N, Stahl N, Torri A, Davis JD, DiCioccio AT. Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatitis. Front Immunol. 2024 Nov 11;15:1466372. doi: 10.3389/fimmu.2024.1466372. eCollection 2024. |
| 36318387 | Derived | Blauvelt A, Wollenberg A, Eichenfield LF, Zhang H, Sierka D, Khokhar FA, Vakil J, Shabbir A, Marco AR, Cyr SL. No Increased Risk of Overall Infection in Adults with Moderate-to-Severe Atopic Dermatitis Treated for up to 4 Years with Dupilumab. Adv Ther. 2023 Jan;40(1):367-380. doi: 10.1007/s12325-022-02322-y. Epub 2022 Nov 1. |
| 35636689 | Derived | Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28. |
| 35503163 | Derived | Beck LA, Deleuran M, Bissonnette R, de Bruin-Weller M, Galus R, Nakahara T, Seo SJ, Khokhar FA, Vakil J, Xiao J, Marco AR, Levit NA, O'Malley JT, Shabbir A. Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2022 May;23(3):393-408. doi: 10.1007/s40257-022-00685-0. Epub 2022 May 3. |
| 34897582 | Derived | Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13. |
| 34714527 | Derived | Yosipovitch G, de Bruin-Weller M, Armstrong A, Wu JJ, Herranz P, Thaci D, Delevry D, Bagousse GB, Zhang R, Shumel B, Rossi AB, Chao J. Dupilumab Treatment Provides Sustained Improvements Over 2 Years in Symptoms and Quality of Life in Adults with Atopic Dermatitis. Dermatol Ther (Heidelb). 2021 Dec;11(6):2147-2157. doi: 10.1007/s13555-021-00630-9. Epub 2021 Oct 29. |
| 33557637 | Derived | Beck LA, Thaci D, Deleuran M, de Bruin-Weller M, Chen Z, Khokhar FA, Zhang M, Ozturk ZE, Shumel B. Laboratory safety of dupilumab for up to 3 years in adults with moderate-to-severe atopic dermatitis: results from an open-label extension study. J Dermatolog Treat. 2022 May;33(3):1608-1616. doi: 10.1080/09546634.2020.1871463. Epub 2021 Feb 8. |
| 32557382 | Derived | Beck LA, Thaci D, Deleuran M, Blauvelt A, Bissonnette R, de Bruin-Weller M, Hide M, Sher L, Hussain I, Chen Z, Khokhar FA, Beazley B, Ruddy M, Patel N, Graham NMH, Ardeleanu M, Shumel B. Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. Am J Clin Dermatol. 2020 Aug;21(4):567-577. doi: 10.1007/s40257-020-00527-x. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dupilumab | Participants received repeated doses of dupilumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events (TEAEs) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Posted | Number | Number of Events | Up to 272 weeks |
|
|
| |||||||||||||||||||||||||||
| Primary | OPTIONAL SUB-STUDY: Number of Adverse Events of Special Interest (AESIs) Through the Last Study Visit After Switching to the New Dupilumab Drug Product | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | The sub-study SAF includes all patients who receive new dupilumab drug product in the sub-study. | Posted | Number | Events | Up to 24 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Serious Adverse Events (SAEs) of Special Interest | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Posted | Number | Events | Up to 272 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of AESIs | Rate (events per patient-year) of AESIs Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Posted | Number | Events per Patient-Year | Up to 272 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Number of AESIs | Adverse events of special interest in this study include: Anaphylactic reactions, Systemic hypersensitivity reactions, Helminthic infections, Any severe type of conjunctivitis or blepharitis, Keratitis, Clinically symptomatic eosinophilia (or eosinophilia associated with clinical symptoms) | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Posted | Number | Events | Up to 272 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score = 0-1 at Each Visit | IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Eczema Area and Severity Index (EASI)-75 (≥75% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Low Disease Activity State (eg, IGA ≤2) at Each Visit | Low disease activity state is defined as an IGA score of ≤2 [mild = 2, almost clear = 1, or clear = 0] | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in EASI Score at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, induration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Posted | Mean | Standard Deviation | Score on a scale | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in EASI Score at Each Visit | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Posted | Mean | Standard Deviation | Percent of Change | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With EASI-50 (≥50% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | EASI-50 was defined as >=50% reduction in EASI scores from baseline of the parent study | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With EASI-90 (≥90% Reduction in EASI Scores From Baseline of the Parent Study) at Each Visit | EASI-90 was defined as >=90% reduction in EASI scores from baseline of the parent study | The safety analysis set (SAF) will include all patients who received any study drug; it is based on the treatment received (as treated). Here 'n' = number of evaluable participants at the specified timeframe | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 272 (End of Study)" |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pruritus Numerical Rating Scale (NRS) in Parent Study | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | The safety analysis set (SAF) includes all patients who received any study drug; it is based on the treatment received. Participants recorded Pruritus score using IVRS (Interactive Voice Recording System) at specified timepoints | Posted | Mean | Standard Deviation | Score on a Scale | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Pruritus NRS | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | The safety analysis set (SAF) includes all patients who received any study drug; it is based on the treatment received. Participants recorded Pruritus score using IVRS (Interactive Voice Recording System) at specified timepoints | Posted | Mean | Standard Deviation | Percent Change | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥3 From Baseline | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | The safety analysis set (SAF) includes all patients who received any study drug; it is based on the treatment received. Participants recorded Pruritus score using IVRS (Interactive Voice Recording System) at specified timepoints | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Improvement (Reduction) of Pruritus NRS ≥4 From Baseline | The Pruritus NRS is an assessment tool for patients to report the intensity of their pruritus (itch), using a scale from 0-10, where 0 is no itch and 10 is the worst itch imaginable. Daily peak pruritus NRS score is the worst one between morning and evening scores of the day. Baseline Pruritus NRS is determined based on average of daily peak NRS scores during the 7 days immediately preceding randomization. A minimum of 4 daily scores out of 7 days is required to calculate baseline average score. Weekly worst score is calculated by taking the worst score within the week | The safety analysis set (SAF) includes all patients who received any study drug; it is based on the treatment received. Participants recorded Pruritus score using IVRS (Interactive Voice Recording System) at specified timepoints | Posted | Number | Percentage of Participants | Up to 272 weeks (End of Study), "Baseline, Weeks 1, 4, 16, 36, 52, 100, 124, 156, 172, 188, 204, 220, 236, 252, 272 (End of Study)" |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Rescue Treatment: Overall | This included all participants who received any study drug. | Posted | Number | Percentage of Participants | Up to 272 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Rescue Treatment: Systemic Treatment | This included all participants who received any study drug. | Posted | Number | Percentage of Participants | Up to 272 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Requiring Rescue Treatment: Phototherapy | This included all participants who received any study drug. | Posted | Number | Percentage of Participants | Up to 272 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Dermatology Life Quality Index (DLQI) | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL | Administered only to the subset of participants who fluently spoke the language for which a validated translation of the questionnaire was available, at time points according to the Schedule of Events as described in the study protocol. This included all participants who received any study drug. | Posted | Mean | Standard Deviation | Score on a scale | Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | Changes From Current Study Baseline to Prespecified Time Points Through the End of the Study: Patient Oriented Eczema Measure (POEM) | The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults. The format is a response to 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 to 28; a high score is indicative of a poor QOL. | Administered only to the subset of participants who fluently speak the language for which a validated translation of the questionnaire is available. This included all participants who received any study drug. | Posted | Mean | Standard Deviation | Score on a scale | Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | Changes From Parent Study Baseline to Prespecified Time Points Through the End of the Study: EuroQol-5D (EQ-5D) | The EuroQOL 5-Dimension Health Questionnaire (EQ-5D) is a standardized measure of health status developed by the EuroQOL Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The minimum value for the single index utility score is -0.594 (Best imaginable health state) and the maximum value for the single index utility score is 1 (Worst imaginable health state). | Administered only to the subset of participants who fluently speak the language for which a validated translation of the questionnaire is available. This included all participants who received any study drug. | Posted | Mean | Standard Deviation | Score on a scale | Up to 272 weeks (End of Study), "Baseline, Weeks 12, 24, 36, 48, 76, 100, 124, 148, 272 (End of Study)" |
|
| ||||||||||||||||||||||||||
| Secondary | OPTIONAL SUB-STUDY: Ctrough of Functional Dupilumab in Serum Before and After Switching to the New Dupilumab Drug Product | The sub-study ADA population includes all treated patients who receive new dupilumab drug product and have at least one non-missing anti-dupilumab antibody result at any time during the sub-study period after the first dose of new dupilumab drug product. | Posted | Mean | Standard Deviation | mg/L | Up to week 12 |
|
| |||||||||||||||||||||||||||
| Secondary | OPTIONAL SUB-STUDY: Incidence of Treatment-emergent Anti-drug Antibody (ADA) Response in Patients Receiving the New Dupilumab Drug Product | For participants receiving dupilumab from a new manufacturing process, ADA baseline was defined as the baseline visit in the sub-study, or at the end of the main study, dependent on available data. | The sub-study ADA population includes all treated patients who receive new dupilumab drug product and have at least one non-missing anti-dupilumab antibody result at any time during the sub-study period after the first dose of new dupilumab drug product. No data collected. | Posted | Up to 24 Weeks |
|
|
From first dose to end of study (plus extension), approximately 272 weeks
Participants received repeated doses of dupilumab
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dupilumab | Participants received repeated doses of dupilumab | 3 | 2,677 | 283 | 2,677 | 1,613 | 2,677 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Eczema herpeticum | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatitis A | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Herpes zoster disseminated | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Infected dermal cyst | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Keratitis bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Superinfection bacterial | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Viral corneal ulcer | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Granular cell tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Hodgkin's disease lymphocyte predominance type stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Laryngeal cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Ovarian germ cell teratoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Seminoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| T-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Sternal fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Transplant dysfunction | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Traumatic arthrosis | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Incarcerated umbilical hernia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ectropion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Entropion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atopic keratoconjunctivitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Corneal neovascularisation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Corneal perforation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eyelid cyst | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Keratoconus | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Mydriasis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Optic neuropathy | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal septum disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alopecia areata | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chordae tendinae rupture | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Alcohol abuse | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Emotional distress | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| "Schizophrenia, paranoid type" | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cholestasis of pregnancy | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hepatorenal syndrome | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Calculus urethral | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| IgA nephropathy | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Aortic arteriosclerosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cyst | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA (18.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Congenital knee deformity | Congenital, familial and genetic disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dolichocolon | Congenital, familial and genetic disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Meniere's disease | Ear and labyrinth disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Female sterilisation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA (18.0) | Systematic Assessment |
|
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Regeneron Pharmaceuticals, Inc. | 1-844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2019 | Jun 23, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Week 0 |
|
| ||||
| Week 12 |
|
|