Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    15
  • sponsor
    University of California, San Francisco
Updated on 16 February 2022
skin lesion
atopy
eczema
phototherapy
dupilumab

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.

Description

Fifteen subjects with moderate to severe AD will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). Biopsy samples from AD subjects and surgical discard samples will undergo molecular profiling. Skin swabs and stool samples will be collected and banked for future analysis. The reason to treat patients for 52 weeks is to have the ability to correlate early molecular events with clinical outcomes at week 52.

Details
Condition Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema, Atopic Dermatitis and Related Conditions
Treatment Dupilumab
Clinical Study IdentifierNCT03293030
SponsorUniversity of California, San Francisco
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

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
% 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-, 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)
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