Status:
COMPLETED
Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Regeneron Pharmaceuticals
Sanofi
Conditions:
Atopic Dermatitis
Atopic Dermatitis Eczema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed 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 wil...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03293030
Start Date
October 22 2018
End Date
February 23 2023
Last Update
November 14 2025
Active Locations (1)
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1
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, United States, 94118