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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to.
The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with omalizumab | Other | This is an open label study of omalizumab with no placebo. Participants who meet study inclusion criteria and are enrolled in the study will receive omalizumab. The dose of omalizumab will be based on participant's weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug | omalizumab injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants without dose limiting symptoms | Consumption of a single dose of 600mg or more of food protein without dose-limiting symptoms during the week 24 Double-blind, Placebo-controlled, Food Challenge | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Wood, MD | Contact | 410-955-5883 | rwood@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Robert Wood, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38407394 | Result | Wood RA, Togias A, Sicherer SH, Shreffler WG, Kim EH, Jones SM, Leung DYM, Vickery BP, Bird JA, Spergel JM, Iqbal A, Olsson J, Ligueros-Saylan M, Uddin A, Calatroni A, Huckabee CM, Rogers NH, Yovetich N, Dantzer J, Mudd K, Wang J, Groetch M, Pyle D, Keet CA, Kulis M, Sindher SB, Long A, Scurlock AM, Lanser BJ, Lee T, Parrish C, Brown-Whitehorn T, Spergel AKR, Veri M, Hamrah SD, Brittain E, Poyser J, Wheatley LM, Chinthrajah RS. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024 Mar 7;390(10):889-899. doi: 10.1056/NEJMoa2312382. Epub 2024 Feb 25. |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |