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

July 30, 2018 updated by: Regeneron Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

176

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Regeneron Investigational Site
      • Birmingham, Alabama, United States, 35209
        • Regeneron Investigational Site
    • Arkansas
      • Fort Smith, Arkansas, United States, 72916
        • Regeneron Investigational Site
    • California
      • 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
        • Regeneron Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80220
        • Regeneron Investigational Site
    • Florida
      • Coral Gables, Florida, United States, 33613
        • Regeneron Investigational Site
      • Tampa, Florida, United States, 33612
        • Regeneron Investigational Site
    • Illinois
      • Normal, Illinois, United States, 61761
        • Regeneron Investigational Site
      • Skokie, Illinois, United States, 60077
        • Regeneron Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Regeneron Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Regeneron Investigational Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • Regeneron Investigational Site
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Regeneron Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Regeneron Investigational Site
      • Windsor, New Jersey, United States, 08520
        • Regeneron Investigational Site
    • New York
      • 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
        • Regeneron Investigational Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Regeneron Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • Regeneron Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Regeneron Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97223
        • Regeneron Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29420
        • Regeneron Investigational Site
      • Greer, South Carolina, United States, 29650
        • Regeneron Investigational Site
    • Texas
      • 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
        • Regeneron Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Regeneron Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Regeneron Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
To week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with an AI device-associated PTF
Time Frame: To week 12
To week 12
Percentage of patients with an AI device-associated PTF
Time Frame: To week 12
To week 12
Number of AI device-associated product technical complaints (PTCs) divided by total number of actual injections
Time Frame: To week 12
To week 12
Type of AI device-associated PTCs divided by total number of actual injections
Time Frame: To week 12
To week 12
Number of patients with an AI device-associated PTC
Time Frame: To week 12
To week 12
Percentage of patients with an AI device-associated PTC
Time Frame: To week 12
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
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
To week 12
Number of patients with an AI device-associated failure to deliver dose
Time Frame: To week 12
To week 12
Percentage of patients with an AI device-associated failure to deliver dose
Time Frame: To week 12
To week 12
Number of patients with response to patient satisfaction questions with the AI device
Time Frame: To week 12
To week 12
Percentage of patients with response to patient satisfaction questions with the AI device
Time Frame: To week 12
To week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Actual)

November 14, 2017

Study Completion (Actual)

February 12, 2018

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (Actual)

February 10, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R668-AD-1607

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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