Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

Open to people ages 18 years and up

• Ability to provide written informed consent and comply with the protocol.
• At least 18 years of age.
• Diagnosis of chronic atopic dermatitis for at least 3 years prior to enrollment.
• Subject is considered a candidate for phototherapy or systemic therapy
• Eczema Area and Severity Index (EASI) score ≥ 16
• Investigator Global Assessment (IGA) ≥ 3
• 10% body surface area (BSA) or greater
• Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods).
• Physical exam within clinically acceptable limits.

• Subject is unable to provide written informed consent or comply with the protocol.
• Subject is younger than 18 years of age.
• Subject has had atopic dermatitis for less than 3 years prior to enrollment.
• Subject with mild atopic dermatitis (EASI<16 and IGA<3) or is not a candidate for phototherapy or systemic treatments.
• Subject with current, or a history of, severe atopic dermatitis well controlled on current therapy.
• Serious known infection.
• History of immunosuppression (including human immunodeficiency virus (HIV))
• History of malignancy within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
• Severe concomitant illnesses.
• Having used immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.) or phototherapy within 4 weeks before the baseline visit.
• Treatment with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.
• Treatment with any cell-depleting agents including but not limited to rituximab: within 6 months before the baseline visit, or until lymphocyte count returns to normal, whichever is longer, or use of other biologics: within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer.
• Physical or laboratory exam not within clinically acceptable limits.
• Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her from safely participating in this study or interfere with the evaluation of the subject's atopic dermatitis.
• History of known or suspected intolerance to any of the ingredients of the investigational study product.
• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>10 mIU/mL).