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Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

CompletedPhase 4

Sponsor: University of California, San Francisco

Conditions: Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema, Atopic Dermatitis and Related Conditions

Interventions: Dupilumab

Countries: United States

This is a single-arm, open-label study to examine the effect of dupilumab on the immunologic and genetic environment within atopic dermatitis skin lesions.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 ≥ 12
* 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.

Exclusion Criteria:

* 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\<12 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).

Locations (1)

San Francisco, California, United States