Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Eczema; Atopic Dermatitis; Atopic Dermatitis Eczema; Atopic Dermatitis and Related Conditions
• Intervention / Treatment: Drug: Dupilumab

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 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94118
      • UCSF Psoriasis and Skin Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab treatment; 15 subjects will receive dupilumab for a treatment period of 52 weeks (i.e. last injection on week 50). All subjects will undergo skin biopsies for molecular profiling.	Drug: Dupilumab; Dupilumab treatment; Other Names: Dupixent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in CD4+ T Effector Cells Expressing IL4 in Dupilumab-treated Subjects at Week 12 vs Week 0	The percent change in CD4+ T effector cells expressing IL-4 in dupilumab-treated subjects at week 12 vs week 0 was calculated as follows. A single value was derived for the entire population with pooled samples from pre- and post-intervention time points, which was then used to calculate a percent change between the two periods. Specifically, the mean M1 across subjects of the percentage of CD4+ T effector cells expressing IL4 was computed at week 0. The mean M2 across subjects of the percentage of CD4+ T effector cells expressing IL4 was computed at week 12. The final result was calculated as: (M1-M2)/M1*100. Therefore, the result is a number and there is no central tendency metric.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Differentially Expressed Genes in Cutaneous CD4+ T Cells Between Week 0 and Week 12 in Dupilumab-treated Subjects	A single value was derived for the entire population with pooled samples from pre- and post-intervention time points, which was then used to calculate an percent change between the two periods. Specifically, single cell RNA-sequencing was used to calculate the number of differentially expressed genes in cutaneous CD4+ T cells between week 0 and week 12 in dupilumab-treated subjects. The calculation was performed in the software package Seurat (RRID:SCR_016341) using the FindMarkers function, which utilizes a non-parametric Wilcoxon rank-sum test. Genes were considered significantly differentially expressed if the adjusted p-value < 0.05 and the absolute value of log2(Fold Change) > 1.0. Therefore, this measure is reported as a number and there is no central tendency metric.	12 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Sanofi; Regeneron Pharmaceuticals
• Investigators: Principal Investigator: Wilson Liao, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; dupilumab; atopic eczema
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Eczema; dupilumab
• Other Study ID Numbers: Dupilumab Immunogenetics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No