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Impact of Increased Immunoglobulin E to Anti-herpes Simplex Virus -1 Innate Immune Responses in Atopic Dermatitis Patients With Eczema Herpeticum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04060550
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
National Jewish Health

Study Description
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Brief Summary:
This study investigates whether blood monocytes' surface bound- immunoglobulin E affects the innate immune responses against herpes simplex viruses in atopic dermatitis patients with eczema herpeticum.

Condition or disease Intervention/treatment
Atopic Dermatitis With a History of Eczema Herpeticum Atopic Dermatitis Without a History of Eczema Herpeticum Health Controls Without Atopy Biological: Xolair

Detailed Description:
Some of atopic dermatitis patients (AD) have severe herpes simplex viral (HSV) infections, which could cause erosive skin lesions all over the body. This condition is termed as eczema herpeticum (ADEH+). Scientists have found that ADEH+ patients have significantly increased blood immunoglobulin (Ig) E compared to AD patients without eczema herpeticum and healthy people. Increased IgE in blood could bound to immune cells' surface, such as monocytes. Since monocytes serve as the first line defense to fight viral infection, their surface-bound IgE may interfere their anti-viral immune responses, and consequently results in more severe viral infections. The purpose of this study is to learn more about how increased IgE affect body's immune ability to fight herpes simplex viruses. This study includes three groups: AD patient without eczema herpeticum complication(ADEH-); AD patient with eczema herpeticum complication(ADEH+) and healthy controls. Study results will be compared between groups.
Study Design
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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigate the Impact of Increased IgE on Innate Anti-herpes Simplex Virus 1 Responses in the Eczema Herpeticum Patients
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 15, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Normal controls
No history of skin disease and atopy
 Biological: Xolair
This is in vitro mechanistic study. No drug will be given in vivo to patients.
Other Name: omalizumab
ADEH-
Atopic dermatitis without a history of eczema herpeticum
 Biological: Xolair
This is in vitro mechanistic study. No drug will be given in vivo to patients.
Other Name: omalizumab
ADEH+
Atopic dermatitis with a history of eczema herpeticum
 Biological: Xolair
This is in vitro mechanistic study. No drug will be given in vivo to patients.
Other Name: omalizumab


Outcome Measures
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Primary Outcome Measures :
  1. Monocytes surface bound IgE quantities [ Time Frame: One day ]
    Relative quantities of surface bound IgE


Biospecimen Retention:   Samples Without DNA
Peripheral blood, monocytes purified from peripheral blood

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

One of the following groups:

  1. A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.
  2. A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.
  3. Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.
Criteria

Inclusion Criteria:

  • Age 16-65 years old, age, sex and race match among non-atopic, ADEH- and ADEH+.

  • Participant and/or parent guardian must be able to understand and provide informed consent, and fits in one of the following conditions:

    1. A history of AD with a history of eczema herpeticum, ADEH+, as diagnosed using the Atopic Dermatitis Research Network Standard Diagnostic Criteria.
    2. A history of AD without a history of eczema herpeticum, ADEH-, as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria, and no first degree relatives with a history of EH.
    3. Non-atopic as diagnosed using Atopic Dermatitis Research Network Standard Diagnostic Criteria.

Exclusion Criteria:

  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol
  • Known or suspected immunosuppression
  • Severe concomitant illness(es)
  • Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
  • Known sensitivity to study drug(s) or class of study drug(s)
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
  • Use of any other investigational agent in the last 30 days
Contacts and Locations
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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): NCT04060550


Contacts
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Contact: Lianghua Bin, MD&PhD 3032702055 binl@njhealth.org
Contact: Donald Leung, MD&PhD 3033981886 leungd@njhealth.org

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
Contact: Patricia Taylor, NP-C    303-398-1067 ext 1067    taylorp@njhealth.org   
Principal Investigator: Lianghua Bin, MD & PhD         
Sub-Investigator: Donald Leung, MD & PhD         
Sponsors and Collaborators
National Jewish Health
Genentech, Inc.
More Information
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Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT04060550    
Other Study ID Numbers: ML41620
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Jewish Health:
Atopic dermatitis
Eczema herpeticum
Immunoglobulin E
Herpes simplex virus
Additional relevant MeSH terms:
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Herpes Simplex
Kaposi Varicelliform Eruption
Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents