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

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ClinicalTrials.gov Identifier: NCT03050151
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Atopic Disorders Eczema, Atopic Drug: Dupilumab Device: Auto-injector Device Device: Prefilled syringe Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis
Actual Study Start Date : February 28, 2017
Actual Primary Completion Date : November 14, 2017
Actual Study Completion Date : February 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: 1 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by auto-injector device
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe

Device: Auto-injector Device
Delivery of Dupilumab by auto-injector device

Experimental: 2 - Dupilumab (Part A)
Dose (dose 1) as per protocol delivered by prefilled syringe
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe

Device: Prefilled syringe
Delivery of Dupilumab by prefilled syringe

Experimental: 3 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by auto-injector device
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe

Device: Auto-injector Device
Delivery of Dupilumab by auto-injector device

Experimental: 4 - Dupilumab (Part B)
Dose (dose 2) as per protocol delivered by prefilled syringe
Drug: Dupilumab
Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe

Device: Prefilled syringe
Delivery of Dupilumab by prefilled syringe




Primary Outcome Measures :
  1. 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 ]
  2. Type of validated AI device-associated PTFs during the treatment period divided by total number of actual injections. [ Time Frame: To week 12 ]

Secondary Outcome Measures :
  1. Number of patients with an AI device-associated PTF [ Time Frame: To week 12 ]
  2. Percentage of patients with an AI device-associated PTF [ Time Frame: To week 12 ]
  3. Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections [ Time Frame: To week 12 ]
  4. Type of AI device-associated PTCs divided by total number of actual injections [ Time Frame: To week 12 ]
  5. Number of patients with an AI device-associated PTC [ Time Frame: To week 12 ]
  6. Percentage of patients with an AI device-associated PTC [ Time Frame: To week 12 ]
  7. 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 ]
  8. 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 [ Time Frame: To week 12 ]
  9. Number of patients with an AI device-associated failure to deliver dose [ Time Frame: To week 12 ]
  10. Percentage of patients with an AI device-associated failure to deliver dose [ Time Frame: To week 12 ]
  11. Number of patients with response to patient satisfaction questions with the AI device [ Time Frame: To week 12 ]
  12. Percentage of patients with response to patient satisfaction questions with the AI device [ Time Frame: To week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050151


Locations
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United States, Alabama
Regeneron Investigational Site
Birmingham, Alabama, United States, 35205
Regeneron Investigational Site
Birmingham, Alabama, United States, 35209
United States, Arkansas
Regeneron Investigational Site
Fort Smith, Arkansas, United States, 72916
United States, California
Regeneron Investigational Site
Long Beach, California, United States, 90808
Regeneron Investigational Site
Los Angeles, California, United States, 90025
Regeneron Investigational Site
Murrieta, California, United States, 92562
Regeneron Investigational Site
Oceanside, California, United States, 92056
Regeneron Investigational Site
Orange, California, United States, 92868
Regeneron Investigational Site
Rolling Hills Estates, California, United States, 90274
Regeneron Investigational Site
Santa Monica, California, United States, 90404
United States, Colorado
Regeneron Investigational Site
Denver, Colorado, United States, 80220
United States, Florida
Regeneron Investigational Site
Coral Gables, Florida, United States, 33613
Regeneron Investigational Site
Tampa, Florida, United States, 33612
United States, Illinois
Regeneron Investigational Site
Normal, Illinois, United States, 61761
Regeneron Investigational Site
Skokie, Illinois, United States, 60077
United States, Indiana
Regeneron Investigational Site
Indianapolis, Indiana, United States, 46256
United States, Maryland
Regeneron Investigational Site
Rockville, Maryland, United States, 20850
United States, Minnesota
Regeneron Investigational Site
Plymouth, Minnesota, United States, 55441
United States, Missouri
Regeneron Investigational Site
Saint Joseph, Missouri, United States, 64506
United States, New Jersey
Regeneron Investigational Site
Berlin, New Jersey, United States, 08009
Regeneron Investigational Site
Windsor, New Jersey, United States, 08520
United States, New York
Regeneron Investigational Site
Corning, New York, United States, 14830
Regeneron Investigational Site
Forest Hills, New York, United States, 11375
Regeneron Investigational Site
New York, New York, United States, 10029
United States, North Carolina
Regeneron Investigational Site
High Point, North Carolina, United States, 27262
Regeneron Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Regeneron Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Regeneron Investigational Site
Portland, Oregon, United States, 97223
United States, South Carolina
Regeneron Investigational Site
Charleston, South Carolina, United States, 29420
Regeneron Investigational Site
Greer, South Carolina, United States, 29650
United States, Texas
Regeneron Investigational Site
Bellaire, Texas, United States, 77401
Regeneron Investigational Site
Fort Worth, Texas, United States, 76244
Regeneron Investigational Site
San Antonio, Texas, United States, 78213
Regeneron Investigational Site
San Antonio, Texas, United States, 78218
Regeneron Investigational Site
Webster, Texas, United States, 77598
United States, Virginia
Regeneron Investigational Site
Norfolk, Virginia, United States, 23502
United States, Washington
Regeneron Investigational Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03050151    
Other Study ID Numbers: R668-AD-1607
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases