Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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

To Learn more

CW ID: 225780
Date Last Changed: July 28, 2017

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
12 and up
Overall Status
Recruiting
Lead Sponsor
Regeneron Pharmaceuticals
Facility Type
N/A

Eligibility

Key Inclusion Criteria:
  • Male or female ≥12 years of age
  • Diagnosis of chronic atopic dermatitis for at least 3 years with inadequate response to topical medications within 6 months before screening
  • Willing and able to comply with all clinic visits and study-related procedures
  • Provide signed informed consent
Key Exclusion Criteria:
  • Patient < 30.0 Kg in weight
  • Patient who has previously participated in a dupilumab clinical study
  • Patient who has taken treatment with
    • 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-?, 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?monthsprior 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 12 weeks before the baseline visit
  • 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)
  • Patient who has skin comorbidities that may interfere with study assessments
  • Patient with a planned or anticipated major surgical procedure during the patient's participation in this study.
  • Women of childbearing potential unwilling to use adequate birth control measures during the study
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study

More Info

R668-AD-1607

Contact

Renee Smith
University of South Florida- Asthma, Allergy, and Immunology Clinical Research Unit
13801 Bruce B. Downs Blvd. Unit #505
Tampa, FL 33613
Phone: 813-631-4024

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