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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001396-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.
The secondary objectives of the study are:
Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to <12 years of age with AD
Co-Primary Objectives are:
Secondary Objective is:
- To evaluate the immunogenicity of dupilumab PFPs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body weight ≥60 kg | Experimental | Administered every two weeks (Q2W) |
|
| Body weight 30 kg to <60 kg | Experimental | Administered Q2W |
|
| Body weight 15 kg to <30 kg | Experimental | Administered every 4 weeks (Q4W) |
|
| Body weight 5 kg to <15 kg | Experimental | Administered Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Weight-tiered dosing administered subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit | Baseline up to week 272 | |
| Number of participants with at least one TEAE per participant year from baseline through the last study visit | Baseline up to week 272 | |
| OPTIONAL SUB-STUDY: Pharmacokinetic (PK) of dupilumab: Peak concentration (Cmax) | Peak serum concentration after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference) | Up to week 16 |
| OPTIONAL SUB-STUDY: PK of dupilumab: Trough concentration (Ctrough) | Drug concentration in serum after multiple doses of dupilumab administered using the PFP (test) relative to the prefilled syringe (reference) | Up to week 16 |
| OPTIONAL SUB-STUDY: Incidence of TEAEs during the 12-week PFP treatment period and during entire sub-study | Up to week 16 | |
| OPTIONAL SUB-STUDY: Incidence of SAEs during the 12-week PFP treatment period and during entire sub-study | Up to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit | Baseline up to week 272 | |
| Incidence of TEAEs of special interest from baseline through the last study visit | Baseline up to week 272 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion / Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regeneron Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| Regeneron Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41926052 | Derived | Paller AS, Pinter A, Wine Lee L, Aschoff R, Zdybski J, Schnopp C, Khokhar FA, Praestgaard AH, Bansal A, Shumel B, Bastian M. Long-Term Safety and Efficacy of Dupilumab Treatment in Children Aged 6 Months to 5 Years with Severe Atopic Dermatitis. Paediatr Drugs. 2026 May;28(3):307-320. doi: 10.1007/s40272-026-00747-4. Epub 2026 Apr 2. | |
| 41903092 |
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|
| Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-clinic visits post-baseline | Baseline up to week 272 |
| Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI from baseline of parent study) response at all in-clinic visits post-baseline | Baseline up to week 272 |
| Change from baseline in EASI score at all in-clinic visits post-baseline | Baseline up to week 272 |
| Percent change from baseline in EASI at all in-clinic visits post-baseline | Baseline up to week 272 |
| Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline | Baseline up to week 272 |
| Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline | Baseline up to week 272 |
| Change from baseline in Children's Dermatology Life Quality Index (CDLQI) for participants ≥4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed | Baseline up to week 272 |
| Change from baseline in Infants' Dermatology Quality of Life Index (IDQOL) for participants <4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed | Baseline up to week 272 |
| Proportion of responders (defined as participants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period | *Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved. | Baseline to week 260 |
| For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained | *Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved. | Baseline to week 260 |
| Number of AD flares during the study | AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment | Baseline to week 272 |
| Annualize event rate of AD flares during the study | AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment | Baseline to week 272 |
| Proportion of participants with at least one flare during the study | AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment | Baseline to week 272 |
| Proportion of well-controlled weeks | Well-controlled weeks are those for which participants or parents/caregivers answer "Yes" AND during which no rescue treatments were administered | Baseline to week 272 |
| OPTIONAL SUB-STUDY: Incidence and titer of treatment-emergent anti-drug antibodies (ADA) (PFP Sub-Study) | Up to 16 weeks |
| Gilbert |
| Arizona |
| 85234 |
| United States |
| Regeneron Investigational Site | Bakersfield | California | 93309 | United States |
| Regeneron Investigational Site | Long Beach | California | 90808 | United States |
| Regeneron Investigational Site | Los Angeles | California | 90027 | United States |
| Regeneron Investigational site | Mission Viejo | California | 92691 | United States |
| Regeneron Investigational Site | Orange | California | 92868 | United States |
| Regeneron Investigational Site | Palo Alto | California | 92304 | United States |
| Regeneron Investigational Site | Rolling Hills Estates | California | 90274 | United States |
| Regeneron Investigational Site | San Diego | California | 92123 | United States |
| Regeneron Investigational Site | Centennial | Colorado | 80112 | United States |
| Regeneron Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| Regeneron Investigational Site | Coral Gables | Florida | 33146 | United States |
| Regeneron Investigational Site | Tampa | Florida | 33613 | United States |
| Regeneron Investigational Site | Tampa | Florida | 33624 | United States |
| Regeneron Investigational Site | Columbus | Georgia | 31904 | United States |
| Regeneron Investigational Site | Macon | Georgia | 31217 | United States |
| Regeneron Investigational Site | Sandy Springs | Georgia | 30328 | United States |
| Regeneron Investigational Site | Chicago | Illinois | 60611 | United States |
| Regeneron Investigational Site | Skokie | Illinois | 60077 | United States |
| Regeneron Investigational site | Plainfield | Indiana | 46168 | United States |
| Regeneron Investigational Site | Rockville | Maryland | 20850 | United States |
| Regeneron Investigational Site | Boston | Massachusetts | 02115 | United States |
| Regeneron Investigational Site | Boston | Massachusetts | 02116 | United States |
| Regeneron Investigational Site | Ypsilanti | Michigan | 48197 | United States |
| Regeneron Investigational Site | Plymouth | Minnesota | 55441 | United States |
| Regeneron Investigational Site | St Louis | Missouri | 63104 | United States |
| Regeneron Investigational Site | Forest Hills | New York | 11375 | United States |
| Regeneron Investigational Site | New York | New York | 10029 | United States |
| Regeneron Investigational Site | Rochester | New York | 14642 | United States |
| Regeneron Investigational Site | Gahanna | Ohio | 43230 | United States |
| Regeneron Investigational Site | Portland | Oregon | 97239 | United States |
| Regeneron Investigational site | Philadelphia | Pennsylvania | 19104 | United States |
| Regeneron Investigational Site | Charleston | South Carolina | 29425 | United States |
| Regeneron Investigational Site | North Charleston | South Carolina | 29420 | United States |
| Regeneron Investigational Site | Bellaire | Texas | 77401-3505 | United States |
| Regeneron Investigational Site | Fort Worth | Texas | 76244 | United States |
| Regeneron Investigational Site | San Antonio | Texas | 78218 | United States |
| Regeneron Investigational Site | Norfolk | Virginia | 23502 | United States |
| Regeneron Investigational Site | Seattle | Washington | 98105 | United States |
| Regeneron Investigational Site | Calgary | Alberta | T2G 1B1 | Canada |
| Regeneron Investigational Site | Surrey | British Columbia | V3R 6A7 | Canada |
| Regeneron Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Regeneron Investigational Site | Markham | Ontario | L3P 1X2 | Canada |
| Regeneron Investigational Site | Ottawa | Ontario | K2C 2N3 | Canada |
| Regeneron Investigational Site | Peterborough | Ontario | K9J 5K2 | Canada |
| Regeneron Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Regeneron Investigational Site | Windsor | Ontario | N8W 1E6 | Canada |
| Regeneron Investigational Site | Montreal | Quebec | H3T 1C5 | Canada |
| Regeneron Investigational Site | Kutná Hora | 28401 | Czechia |
| Regeneron Investigational Site | Prague | 10034 | Czechia |
| Regeneron Investigational Site | Ústí nad Labem | 40113 | Czechia |
| Regeneron Study Site | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Regeneron Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| Regeneron Investigational Site | Münster | North Rhine-Westphal | 48149 | Germany |
| Regeneron Investigational Site | Dresden | Saxony | 01307 | Germany |
| Regeneron Investigational Site | Gera | 07548 | Germany |
| Regeneron Investigational Site | Hamburg | 22149 | Germany |
| Regeneron Investigational Site | Munich | 80337 | Germany |
| Regeneron Study Site | München | 80802 | Germany |
| Regeneron Investigational Site | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
| Regeneron Investigational Site | Kaposvár | 7400 | Hungary |
| Regeneron Investigational Site | Miskolc | 3526 | Hungary |
| Regeneron Investigational Site | Szeged | 6720 | Hungary |
| Regeneron Investigational Site | Ostrowiec Świętokrzyski | Kielce | 27-400 | Poland |
| Regeneron Investigational Site | Wroclaw | Lower Silesian Voivodeship | 50-381 | Poland |
| Regeneron Investigational Site | Wroclaw | Lower Silesian Voivodeship | 50368 | Poland |
| Regeneron Investigational Site | Krakow | Malopolska | 30 363 | Poland |
| Regeneron Investigational Site | Krakow | Malopolska | 31-011 | Poland |
| Regeneron Investigational Site | Katowice | Silesian Voivodeship | 40-648 | Poland |
| Regeneron Investigational Site | Bialystok | 15 453 | Poland |
| Regeneron Investigational Site | Bydgoszcz | 85-065 | Poland |
| Regeneron Investigational Site | Chorzów | 41-500 | Poland |
| Regeneron Investigational Site | Gdansk | 80-152 | Poland |
| Regeneron Investigational Site | Katowice | 40 611 | Poland |
| Regeneron Investigational Site | Krakow | 30 363 | Poland |
| Regeneron Investigational Site | Lodz | 90-265 | Poland |
| Regeneron Investigational Site | Warsaw | 01-142 | Poland |
| Regeneron Investigational Site | Warsaw | 01-817 | Poland |
| Regeneron Investigational Site | Warsaw | 02-758 | Poland |
| Regeneron Investigational Site | Warsaw | 91-142 | Poland |
| Regeneron Investigational Site | London | Greater London | SE1 7EH | United Kingdom |
| Regeneron Investigational Site | Manchester | Lancashire | M13 9WL | United Kingdom |
| Regeneron Investigational Site | Sheffield | South Yorkshire | S10 2TH | United Kingdom |
| Paller AS, Simpson EL, Siegfried EC, Cork MJ, Arkwright PD, Pinter A, Deleuran M, Hong HC, Ma Y, Bansal A, Dubost-Brama A, Nguyen TV. Safety and Efficacy of Treatment with Dupilumab for up to 2 Years in Infants and Young Children with Atopic Dermatitis. Am J Clin Dermatol. 2026 May;27(3):611-620. doi: 10.1007/s40257-026-01018-1. Epub 2026 Mar 28. |
| 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. |
| 38743155 | Derived | Paller AS, Siegfried EC, Simpson EL, Cork MJ, Sidbury R, Chen IH, Khokhar FA, Xiao J, Dubost-Brama A, Bansal A. Dupilumab Safety and Efficacy up to 1 Year in Children Aged 6 Months to 5 Years with Atopic Dermatitis: Results from a Phase 3 Open-Label Extension Study. Am J Clin Dermatol. 2024 Jul;25(4):655-668. doi: 10.1007/s40257-024-00859-y. Epub 2024 May 14. |
| 37750994 | Derived | Cork MJ, Thaci D, Eichenfield LF, Arkwright PD, Chen Z, Thomas RB, Kosloski MP, Dubost-Brama A, Prescilla R, Bansal A, Levit NA. Dupilumab Safety and Efficacy in a Phase III Open-Label Extension Trial in Children 6-11 Years of Age with Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2023 Nov;13(11):2697-2719. doi: 10.1007/s13555-023-01016-9. Epub 2023 Sep 26. |
| 35567671 | Derived | Blauvelt A, Guttman-Yassky E, Paller AS, Simpson EL, Cork MJ, Weisman J, Browning J, Soong W, Sun X, Chen Z, Kosloski MP, Kamal MA, Delevry D, Chuang CC, O'Malley JT, Bansal A. Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Severe Atopic Dermatitis: Results Through Week 52 from a Phase III Open-Label Extension Trial (LIBERTY AD PED-OLE). Am J Clin Dermatol. 2022 May;23(3):365-383. doi: 10.1007/s40257-022-00683-2. Epub 2022 May 14. |
| 34726270 | Derived | Paller AS, Tan JKL, Bagel J, Rossi AB, Shumel B, Zhang H, Abramova A. IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis. Br J Dermatol. 2022 Mar;186(3):496-507. doi: 10.1111/bjd.20872. Epub 2022 Feb 25. |
| 33481203 | Derived | Bansal A, Simpson EL, Paller AS, Siegfried EC, Blauvelt A, de Bruin-Weller M, Corren J, Sher L, Guttman-Yassky E, Chen Z, Daizadeh N, Kamal MA, Shumel B, Mina-Osorio P, Mannent L, Patel N, Graham NMH, Khokhar FA, Ardeleanu M. Conjunctivitis in Dupilumab Clinical Trials for Adolescents with Atopic Dermatitis or Asthma. Am J Clin Dermatol. 2021 Jan;22(1):101-115. doi: 10.1007/s40257-020-00577-1. |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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