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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

Tracking Information
First Submitted Date  ICMJE February 8, 2017
First Posted Date  ICMJE February 10, 2017
Last Update Posted Date August 1, 2018
Actual Study Start Date  ICMJE February 28, 2017
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Number of validated AI device-associated product technical failures (PTFs) [ Time Frame: To week 12 ]
    Number of validated AI device-associated PTFs during the treatment period by actual number of injections
  • Type of validated AI device-associated PTFs [ Time Frame: To week 12 ]
    Type of validated AI device-associated PTFs during the treatment period by actual number of injections
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • 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 [ 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Number of patients with an AI device-associated PTF [ Time Frame: To week 12 ]
  • Number of AI device-associated product technical complaints (PTCs) [ Time Frame: To week 12 ]
  • Type of AI device-associated PTCs [ Time Frame: To week 12 ]
  • Number of patients with an AI device-associated PTC [ Time Frame: To week 12 ]
  • Number of AI device-associated failed drug deliveries [ Time Frame: To week 12 ]
    Defined as patient failure to administer the full dose at a given attempt, excluding PTF
  • Type of AI device-associated failed drug deliveries (defined as patient failure to administer the full dose at a given attempt, excluding PTF) [ Time Frame: To week 12 ]
    Defined as patient failure to administer the full dose at a given attempt, excluding PTF
  • Number of patients with an AI device-associated failure to deliver dose [ Time Frame: To week 12 ]
  • Patient satisfaction with the AI device [ Time Frame: To week 12 ]
    Patient satisfaction questionnaire
  • Serum concentrations of functional dupilumab [ Time Frame: To week 12 ]
    Cmax after the first dose and steady state of SC dupilumab administered using AI device vs PFS
  • Derived pharmacokinetic (PK) parameters [ Time Frame: To week 12 ]
    Area under the Curve (AUC) after the first dose and steady state of SC dupilumab administered using AI device vs PFS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis
Official Title  ICMJE An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atopic Disorders
  • Eczema, Atopic
Intervention  ICMJE
  • 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
  • Device: Prefilled syringe
    Delivery of Dupilumab by prefilled syringe
Study Arms  ICMJE
  • Experimental: 1 - Dupilumab (Part A)
    Dose (dose 1) as per protocol delivered by auto-injector device
    Interventions:
    • Drug: Dupilumab
    • Device: Auto-injector Device
  • Experimental: 2 - Dupilumab (Part A)
    Dose (dose 1) as per protocol delivered by prefilled syringe
    Interventions:
    • Drug: Dupilumab
    • Device: Prefilled syringe
  • Experimental: 3 - Dupilumab (Part B)
    Dose (dose 2) as per protocol delivered by auto-injector device
    Interventions:
    • Drug: Dupilumab
    • Device: Auto-injector Device
  • Experimental: 4 - Dupilumab (Part B)
    Dose (dose 2) as per protocol delivered by prefilled syringe
    Interventions:
    • Drug: Dupilumab
    • Device: Prefilled syringe
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 31, 2017)
176
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2017)
168
Actual Study Completion Date  ICMJE February 12, 2018
Actual Primary Completion Date November 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03050151
Other Study ID Numbers  ICMJE R668-AD-1607
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP