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
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Condition or disease |
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Atopic Dermatitis |
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 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 |

- IgE [ Time Frame: Day 14 ]mesure IgE production in PBMC culture supernatant

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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 |
Inclusion Criteria:
- Male and female subjects aged ≥ 18 years
- Clinical diagnosis of atopic dermatitis or chronic urticaria
Exclusion Criteria:
-

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
Taiwan | |
National Taiwan University Hospital | |
Taipei, Taiwan, 100 |
Principal Investigator: | Chia-Yu Chu, M.D., Ph.D. | Dept of Dermatology, NTUH |
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 |
IgE Atopic Dermatitis antibody allergy |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |