Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis

Conditions
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Atopic Disorders, Eczema, Atopic

Intervention / Treatment
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* Drug: Dupilumab
* Device: Auto-injector Device
* Device: Prefilled syringe


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening Willing and able to comply with all clinic visits and study-related procedures Provide signed informed consent 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: 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 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Dupilumab (Part A)<br>Dose (dose 1) as per protocol delivered by auto-injector device | Drug: Dupilumab<br>* Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe<br>Device: Auto-injector Device<br>* Delivery of Dupilumab by auto-injector device<br>|
| Experimental: 2 - Dupilumab (Part A)<br>Dose (dose 1) as per protocol delivered by prefilled syringe | Drug: Dupilumab<br>* Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe<br>Device: Prefilled syringe<br>* Delivery of Dupilumab by prefilled syringe<br>|
| Experimental: 3 - Dupilumab (Part B)<br>Dose (dose 2) as per protocol delivered by auto-injector device | Drug: Dupilumab<br>* Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe<br>Device: Auto-injector Device<br>* Delivery of Dupilumab by auto-injector device<br>|
| Experimental: 4 - Dupilumab (Part B)<br>Dose (dose 2) as per protocol delivered by prefilled syringe | Drug: Dupilumab<br>* Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe<br>Device: Prefilled syringe<br>* Delivery of Dupilumab by prefilled syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 |