Clinical trial NCT03050151: Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis
Official title: An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Disorders
Eczema, Atopic
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2017-02-10
Enrollment: 176
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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/Exclusion criteria may apply

Primary outcomes:
measure: Number of validated AI device-associated product technical failures (PTFs) during the treatment period divided by total number of actual injections
timeFrame: To week 12
measure: Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections.
timeFrame: To week 12
Secondary outcomes:
measure: Number of patients with an AI device-associated PTF
timeFrame: To week 12
measure: Percentage of patients with an AI device-associated PTF
timeFrame: To week 12
measure: Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections
timeFrame: To week 12
measure: Type of AI device-associated PTCs divided by total number of actual injections
timeFrame: To week 12
measure: Number of patients with an AI device-associated PTC
timeFrame: To week 12
measure: Percentage of patients with an AI device-associated PTC
timeFrame: To week 12
measure: 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
timeFrame: To week 12
measure: 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
timeFrame: To week 12
measure: Number of patients with an AI device-associated failure to deliver dose
timeFrame: To week 12
measure: Percentage of patients with an AI device-associated failure to deliver dose
timeFrame: To week 12
measure: Number of patients with response to patient satisfaction questions with the AI device
timeFrame: To week 12
measure: Percentage of patients with response to patient satisfaction questions with the AI device
timeFrame: To week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Regeneron Investigational Site
state: Alabama
city: Fort Smith
country: United States
facility: Regeneron Investigational Site
state: Arkansas
city: Long Beach
country: United States
facility: Regeneron Investigational Site
state: California
city: Los Angeles
country: United States
facility: Regeneron Investigational Site
state: California
city: Murrieta
country: United States
facility: Regeneron Investigational Site
state: California
city: Oceanside
country: United States
facility: Regeneron Investigational Site
state: California
city: Orange
country: United States
facility: Regeneron Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: Regeneron Investigational Site
state: California
city: Santa Monica
country: United States
facility: Regeneron Investigational Site
state: California
city: Denver
country: United States
facility: Regeneron Investigational Site
state: Colorado
city: Coral Gables
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Investigational Site
state: Florida
city: Normal
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Skokie
country: United States
facility: Regeneron Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Regeneron Investigational Site
state: Indiana
city: Rockville
country: United States
facility: Regeneron Investigational Site
state: Maryland
city: Plymouth
country: United States
facility: Regeneron Investigational Site
state: Minnesota
city: Saint Joseph
country: United States
facility: Regeneron Investigational Site
state: Missouri
city: Berlin
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Windsor
country: United States
facility: Regeneron Investigational Site
state: New Jersey
city: Corning
country: United States
facility: Regeneron Investigational Site
state: New York
city: Forest Hills
country: United States
facility: Regeneron Investigational Site
state: New York
city: New York
country: United States
facility: Regeneron Investigational Site
state: New York
city: High Point
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Regeneron Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: Regeneron Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Regeneron Investigational Site
state: Oregon
city: Charleston
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Regeneron Investigational Site
state: South Carolina
city: Bellaire
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Regeneron Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Webster
country: United States
facility: Regeneron Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Regeneron Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: Regeneron Investigational Site
state: Washington
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: 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.