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Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03293030
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Regeneron Pharmaceuticals
Sanofi
Information provided by (Responsible Party):
Wilson Liao, MD, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Atopic Dermatitis Eczema Eczema Atopic Dermatitis and Related Conditions Drug: Dupilumab Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunogenetic Profiling of Dupilumab for the Treatment of Atopic Dermatitis
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

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 Name: Dupixent




Primary Outcome Measures :
  1. CD4+ T effector cells expressing IL-4 [ Time Frame: 12 weeks ]
    Percentage change from pre-treatment baseline of CD4+ T effector cells expressing IL-4 at weeks 2, 4, 12 in dupilumab-treated patients.


Secondary Outcome Measures :
  1. Number of differentially expressed genes and pathways [ Time Frame: 12 weeks ]
    Number of differentially expressed genes and pathways in each cell population at weeks 2, 4, 12 compared to pre-treatment baseline using RNA-seq.

  2. Microbiome [ Time Frame: 52 weeks ]
    Microbiome samples from skin and stool at weeks 0, 2, 4, 12, and 52 will be banked for future analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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<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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293030


Contacts
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Contact: Quinn Thibodeaux, MD 415-944-7618 psoriasis@ucsf.edu

Locations
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United States, California
UCSF Psoriasis and Skin Treatment Center Recruiting
San Francisco, California, United States, 94118
Contact: Quinn Thibodeaux, MD    415-944-7618    psoriasis@ucsf.edu   
Principal Investigator: Wilson Liao, MD         
Sponsors and Collaborators
University of California, San Francisco
Regeneron Pharmaceuticals
Sanofi
Investigators
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Principal Investigator: Wilson Liao, MD University of California, San Francisco

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Responsible Party: Wilson Liao, MD, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03293030     History of Changes
Other Study ID Numbers: Dupilumab Immunogenetics
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Wilson Liao, MD, University of California, San Francisco:
atopic dermatitis
eczema
dupilumab
atopic eczema

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs