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The Effect of Anti-CεmX on IgE Production (h4B12PBMC)

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ClinicalTrials.gov Identifier: NCT01995747
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
Despite the success of Omalizumab that neutralizes free IgE in blood and interstitial fluids, treatment of many allergic disorders remains an unmet medical need. Omalizumab was approved for patients having serum IgE levels in the range of 30-700 IU/ml. Omalizumab may not be effective for patients with much higher serum IgE levels, such as those with atopic dermatitis. Therefore, an alternative approach that targets IgE-committed B cells directly and inhibits the synthesis of IgE without binding to free IgE will be attractive. Anti-CεmX mAb, developed by Dr. TW Chang in Academia Sinica, binds human mIgE+ cells, including IgE-committed lymphoblasts and memory B cells. Such anti-CεmX mAbs should be able to activate B cell receptor (BCR) signaling, which leads to anergy or apoptosis of mIgE+ B lymphoblasts, and induces ADCC through their Fc portion. Depletion of mIgE+ B cells by anti-CεmX treatment would inhibit the formation of IgE-producing plasma cells, resulting in a long-term attenuation of IgE synthesis that would eventually lead to a desensitized state in allergic patients.

Condition or disease
Atopic Dermatitis

Detailed Description:

This study will collect blood from patients of high serum IgE levels to investigate the function of h4b12, a humanized mAb specific for mIgE+ B cells, and compare the effects of h4B12, Omalizumab, and Rituxumab on the suppression of IgE production and the number of IgE-producing plasma cells. These blood specimens will be collected from 50 patients of atopic dermatitis or urticaria with high serum IgE levels. Fountain Biopharma will carry out the following two in vitro assays to measure the efficacy of h4B12:

  • IgE ELISA to determine the concentration of IgE.
  • IgE ELISPOTto determine the number of IgE-producing plasma cells.
Study Design
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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Effect of Humanized Anti-CεmX Antibody (h4B12) on IgE Production in the PBMC Isolated From Atopic Dermatitis Patients
Study Start Date : February 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. IgE [ Time Frame: Day 14 ]
    mesure IgE production in PBMC culture supernatant


Eligibility Criteria
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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
Sampling Method:   Non-Probability Sample
Study Population
patients of atopic dermatisis
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≥ 18 years
  • Clinical diagnosis of atopic dermatitis or chronic urticaria

Exclusion Criteria:

-

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): NCT01995747


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chia-Yu Chu, M.D., Ph.D. Dept of Dermatology, NTUH
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01995747    
Other Study ID Numbers: 201109045RC
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: November 27, 2013
Last Verified: November 2013
Keywords provided by National Taiwan University Hospital:
IgE
Atopic Dermatitis
antibody
allergy
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases