Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

NCT03293030 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Dupilumab Immunogenetics
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis; Atopic Dermatitis Eczema; Eczema; Atopic Dermatitis and Related Conditions

Keywords

atopic dermatitis; eczema; dupilumab; atopic eczema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Differentially Expressed Genes in Cutaneous CD4+ T Cells Between Week 0 and Week 12 in Dupilumab-treated Subjects

  12 weeks

Study Arms (1)

Dupilumab treatment

EXPERIMENTAL

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

Interventions

Dupilumab DRUG

Dupilumab treatment

Also known as: Dupixent

Dupilumab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• % 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 may not qualify 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\<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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Regeneron Pharmaceuticals: collaborator
• Sanofi: collaborator

Study Sites (1)

UCSF Psoriasis and Skin Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Wilson Liao
• Organization: University of California San Francisco

wilson.liao@ucsf.edu

415-476-8364

Study Officials

• Wilson Liao, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: October 22, 2018
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: November 14, 2025
• Results First Posted: November 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)