Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Regeneron Pharmaceuticals; Sanofi

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 ≥ 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.

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<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).