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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
176
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
Delivery of Dupilumab by auto-injector device
Delivery of Dupilumab by prefilled syringe
Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections
Time frame: To week 12
Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.
Time frame: To week 12
Number of patients with an AI device-associated PTF
Time frame: To week 12
Percentage of patients with an AI device-associated PTF
Time frame: To week 12
Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections
Time frame: To week 12
Type of AI device-associated PTCs divided by total number of actual injections
Time frame: To week 12
Number of patients with an AI device-associated PTC
Time frame: To week 12
Percentage of patients with an AI device-associated PTC
Time frame: 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
Time frame: 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
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Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Birmingham, Alabama, United States
Regeneron Investigational Site
Fort Smith, Arkansas, United States
Regeneron Investigational Site
Long Beach, California, United States
Regeneron Investigational Site
Los Angeles, California, United States
Regeneron Investigational Site
Murrieta, California, United States
Regeneron Investigational Site
Oceanside, California, United States
Regeneron Investigational Site
Orange, California, United States
Regeneron Investigational Site
Rolling Hills Estates, California, United States
Regeneron Investigational Site
Santa Monica, California, United States
...and 27 more locations
Time frame: To week 12
Number of patients with an AI device-associated failure to deliver dose
Time frame: To week 12
Percentage of patients with an AI device-associated failure to deliver dose
Time frame: To week 12
Number of patients with response to patient satisfaction questions with the AI device
Time frame: To week 12
Percentage of patients with response to patient satisfaction questions with the AI device
Time frame: To week 12