The Impact of Dupilumab on Quality of Life in Moderate to Severe Atopic Dermatitis Patients
Condition: Atopic Dermatitis; Atopic Dermatitis Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab
Intervention description: Dupilumab treatment
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atopic dermatitis; eczema; dupilumab

Summary:

      This is a single-arm, open-label study, which will examine the effect of dupilumab on quality
      of life in atopic dermatitis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent and comply with the protocol

          -  At least 18 years of age

          -  Diagnosis of atopic dermatitis at least 6 months prior to enrollment, having stable
             (unchanged) disease for at least 2 months

          -  Non-immune-compromised status

          -  Subjects have moderate-to-severe atopic dermatitis, classified as Eczema Area and
             Severity Index (EASI) score greater than or equal to 6

          -  Subject is considered a candidate for phototherapy or systemic therapy

          -  Subjects of child-bearing potential must have a negative urine pregnancy test within 7
             days prior to first dose of dupilumab

          -  Sexually active subjects of childbearing potential must agree to use medically
             acceptable form of contraception during screening and throughout the study

          -  Subject meets concomitant medication requirements (see below)

        Exclusion Criteria:

          -  Younger than 18 years of age

          -  Has mild atopic dermatitis, classified as EASI score less than 6

          -  History of known or suspected intolerance to any of the ingredients of the
             investigational study product

          -  Evidence of skin conditions other than atopic dermatitis that would interfere with
             study-related evaluations of atopic dermatitis.

          -  History of immune-compromised status [e.g. human immunodeficiency virus (HIV) positive
             status or other immune suppressing drug] or a congenital or acquired immunodeficiency
             or subject testing positive for HIV during screening procedures

          -  Has a poorly controlled medical condition including, but not limited to, unstable
             cardiovascular disease, poorly controlled diabetes, recent stroke, history of
             recurrent infections, or any other condition for which, in the opinion of the
             investigator, participation in the study would place the subject at risk

          -  Has a history of or ongoing drug or alcohol abuse

          -  Is not willing to comply with concomitant medication requirements

          -  Is known, or suspected of being unable to comply with the study protocol

          -  Subjects who are well controlled on current treatment for atopic dermatitis and
             participation in the study may worsen disease control significantly