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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03050151
Phase
PHASE1
Status
Completed

Conditions

  • Atopic Disorders
  • Eczema, Atopic

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
  • Auto-injector Device — DEVICE
    Delivery of Dupilumab by auto-injector device
  • Prefilled syringe — DEVICE
    Delivery of Dupilumab by prefilled syringe

Study Details

To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).

Key Dates

Start date
Feb 28, 2017
Status verified
May 2018
Primary completion
Nov 14, 2017
Completion
Feb 12, 2018

Study Design

Enrollment
176 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 - Dupilumab (Part A)
    Dose (dose 1) as per protocol delivered by auto-injector device
  • Experimental: 2 - Dupilumab (Part A)
    Dose (dose 1) as per protocol delivered by prefilled syringe
  • Experimental: 3 - Dupilumab (Part B)
    Dose (dose 2) as per protocol delivered by auto-injector device
  • Experimental: 4 - Dupilumab (Part B)
    Dose (dose 2) as per protocol delivered by prefilled syringe

Primary Outcome Measure

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 ]

Locations (37)

FacilityCityStateZIPSite coordinators
Regeneron Investigational SiteBirminghamAlabama35205-
Regeneron Investigational SiteBirminghamAlabama35209-
Regeneron Investigational SiteFort SmithArkansas72916-
Regeneron Investigational SiteLong BeachCalifornia90808-
Regeneron Investigational SiteLos AngelesCalifornia90025-
Regeneron Investigational SiteMurrietaCalifornia92562-
Regeneron Investigational SiteOceansideCalifornia92056-
Regeneron Investigational SiteOrangeCalifornia92868-
Regeneron Investigational SiteRolling Hills EstatesCalifornia90274-
Regeneron Investigational SiteSanta MonicaCalifornia90404-
Regeneron Investigational SiteDenverColorado80220-
Regeneron Investigational SiteCoral GablesFlorida33613-
Regeneron Investigational SiteTampaFlorida33612-
Regeneron Investigational SiteNormalIllinois61761-
Regeneron Investigational SiteSkokieIllinois60077-
Regeneron Investigational SiteIndianapolisIndiana46256-
Regeneron Investigational SiteRockvilleMaryland20850-
Regeneron Investigational SitePlymouthMinnesota55441-
Regeneron Investigational SiteSaint JosephMissouri64506-
Regeneron Investigational SiteBerlinNew Jersey08009-
Regeneron Investigational SiteWindsorNew Jersey08520-
Regeneron Investigational SiteCorningNew York14830-
Regeneron Investigational SiteForest HillsNew York11375-
Regeneron Investigational SiteNew YorkNew York10029-
Regeneron Investigational SiteHigh PointNorth Carolina27262-
Regeneron Investigational SiteRaleighNorth Carolina27612-
Regeneron Investigational SiteTulsaOklahoma74136-
Regeneron Investigational SitePortlandOregon97223-
Regeneron Investigational SiteCharlestonSouth Carolina29420-
Regeneron Investigational SiteGreerSouth Carolina29650-
Regeneron Investigational SiteBellaireTexas77401-
Regeneron Investigational SiteFort WorthTexas76244-
Regeneron Investigational SiteSan AntonioTexas78213-
Regeneron Investigational SiteSan AntonioTexas78218-
Regeneron Investigational SiteWebsterTexas77598-
Regeneron Investigational SiteNorfolkVirginia23502-
Regeneron Investigational SiteTacomaWashington98405-

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