Atopic Disorders, Eczema, Atopic
Conditions
Brief summary
To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).
Detailed description
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.
Interventions
DRUGDupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
DEVICEAuto-injector Device
Delivery of Dupilumab by auto-injector device
DEVICEPrefilled syringe
Delivery of Dupilumab by prefilled syringe
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening 2. Willing and able to comply with all clinic visits and study-related procedures 3. Provide signed informed consent Key
Exclusion criteria
1. Patient \< 30.0 kilograms (Kg) in weight 2. Patient who has previously participated in a dupilumab clinical study 3. Patient who has been treated with the following: * An investigational drug within 8 weeks or within 5 half-lives (if known),whichever is longer, before the baseline visit * Immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mufti, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or Phototherapy for AD within 4 weeks before the baseline visit * An experimental monoclonal antibody within 5 half-lives or within 6◦months prior to visit 1 if the half-life is unknown * Biologic agents within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer * Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to visit 1 * A live (attenuated) vaccine within 4 weeks before the baseline visit 4. 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) 5. Patient who has skin comorbidities that may interfere with study assessments 6. Patient with a planned or anticipated major surgical procedure during the patient's participation in this study 7. Women of childbearing potential unwilling to use adequate birth control measures during the study 8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections | 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 |
| Number of patients with an AI device-associated PTF | 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 |
| 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 |
| Percentage of patients with an AI device-associated PTF | To week 12 |
Countries
United States
Outcome results
None listed