Not provided
Not provided
Not provided
Not provided
Not provided
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
To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).
Study is conducted in 2 parts: part A and part B.
Part A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe.
Once part A is completely enrolled, part B will randomize patients with moderate-to-severe AD to receive dupilumab (dose 2) by auto-injector (AI) device or prefilled syringe.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Dupilumab (Part A) | Experimental | Dose (dose 1) as per protocol delivered by auto-injector device |
|
| 2 - Dupilumab (Part A) | Experimental | Dose (dose 1) as per protocol delivered by prefilled syringe |
|
| 3 - Dupilumab (Part B) | Experimental | Dose (dose 2) as per protocol delivered by auto-injector device |
|
| 4 - Dupilumab (Part B) | Experimental | Dose (dose 2) as per protocol delivered by prefilled syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections | To week 12 | |
| Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections. | To week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with an AI device-associated PTF | To week 12 | |
| Percentage of patients with an AI device-associated PTF | To week 12 | |
| Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Patient < 30.0 kilograms (Kg) in weight
Patient who has previously participated in a dupilumab clinical study
Patient who has been treated with the following:
Patient who has initiated treatment with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period (patients may continue using stable doses of such moisturizers if initiated before the screening visit)
Patient who has skin comorbidities that may interfere with study assessments
Patient with a planned or anticipated major surgical procedure during the patient's participation in this study
Women of childbearing potential unwilling to use adequate birth control measures during the study
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
Note: Other protocol defined Inclusion/Exclusion criteria may 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 Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| Regeneron Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Auto-injector Device | Device | Delivery of Dupilumab by auto-injector device |
|
| Prefilled syringe | Device | Delivery of Dupilumab by prefilled syringe |
|
| To week 12 |
| Type of AI device-associated PTCs divided by total number of actual injections | To week 12 |
| Number of patients with an AI device-associated PTC | To week 12 |
| Percentage of patients with an AI device-associated PTC | To week 12 |
| Number of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections | To week 12 |
| Type of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) divided by total number of actual injections | To week 12 |
| Number of patients with an AI device-associated failure to deliver dose | To week 12 |
| Percentage of patients with an AI device-associated failure to deliver dose | To week 12 |
| Number of patients with response to patient satisfaction questions with the AI device | To week 12 |
| Percentage of patients with response to patient satisfaction questions with the AI device | To week 12 |
| Birmingham |
| Alabama |
| 35209 |
| United States |
| Regeneron Investigational Site | Fort Smith | Arkansas | 72916 | United States |
| Regeneron Investigational Site | Long Beach | California | 90808 | United States |
| Regeneron Investigational Site | Los Angeles | California | 90025 | United States |
| Regeneron Investigational Site | Murrieta | California | 92562 | United States |
| Regeneron Investigational Site | Oceanside | California | 92056 | United States |
| Regeneron Investigational Site | Orange | California | 92868 | United States |
| Regeneron Investigational Site | Rolling Hills Estates | California | 90274 | United States |
| Regeneron Investigational Site | Santa Monica | California | 90404 | United States |
| Regeneron Investigational Site | Denver | Colorado | 80220 | United States |
| Regeneron Investigational Site | Coral Gables | Florida | 33613 | United States |
| Regeneron Investigational Site | Tampa | Florida | 33612 | United States |
| Regeneron Investigational Site | Normal | Illinois | 61761 | United States |
| Regeneron Investigational Site | Skokie | Illinois | 60077 | United States |
| Regeneron Investigational Site | Indianapolis | Indiana | 46256 | United States |
| Regeneron Investigational Site | Rockville | Maryland | 20850 | United States |
| Regeneron Investigational Site | Plymouth | Minnesota | 55441 | United States |
| Regeneron Investigational Site | Saint Joseph | Missouri | 64506 | United States |
| Regeneron Investigational Site | Berlin | New Jersey | 08009 | United States |
| Regeneron Investigational Site | Windsor | New Jersey | 08520 | United States |
| Regeneron Investigational Site | Corning | New York | 14830 | 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 | High Point | North Carolina | 27262 | United States |
| Regeneron Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Regeneron Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Regeneron Investigational Site | Portland | Oregon | 97223 | United States |
| Regeneron Investigational Site | Charleston | South Carolina | 29420 | United States |
| Regeneron Investigational Site | Greer | South Carolina | 29650 | United States |
| Regeneron Investigational Site | Bellaire | Texas | 77401 | United States |
| Regeneron Investigational Site | Fort Worth | Texas | 76244 | United States |
| Regeneron Investigational Site | San Antonio | Texas | 78213 | United States |
| Regeneron Investigational Site | San Antonio | Texas | 78218 | United States |
| Regeneron Investigational Site | Webster | Texas | 77598 | United States |
| Regeneron Investigational Site | Norfolk | Virginia | 23502 | United States |
| Regeneron Investigational Site | Tacoma | Washington | 98405 | United States |
| 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