Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Wilson Liao
Headshot of Wilson Liao
Wilson Liao

Description

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.

Details

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.

Keywords

Atopic Dermatitis, Atopic Dermatitis Eczema, Eczema, Atopic Dermatitis and Related Conditions, dupilumab, atopic eczema, Dermatitis

Eligibility

You can join if…

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.

You CAN'T join if...

  • 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).

Location

  • UCSF Psoriasis and Skin Treatment Center accepting new patients
    San Francisco California 94118 United States

Lead Scientist at UCSF

  • Wilson Liao
    Dr. Liao is Professor and Associate Vice Chair of Research in the UCSF Department of Dermatology. He serves as Director of the UCSF Psoriasis and Skin Treatment Center and is deeply engaged in patient care, clinical trials, and translational research.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03293030
Phase
Phase 4 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated