Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
NCT ID: NCT01781637
Last Updated: 2023-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
36 participants
INTERVENTIONAL
2013-01-31
2022-05-31
Brief Summary
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Detailed Description
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Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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omalizumab group
Patients will receive omalizumab.
Omalizumab
subcutaneous injection
placebo
Patients will receive placebo.
placebo
subcutaneous injection
Interventions
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Omalizumab
subcutaneous injection
placebo
subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
* ImmunoCAP IgE level to peanut \> 10 kU/L.
* Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Exclusion Criteria
* Positive reaction to the placebo on DBPCFC.
* Previous reaction to omalizumab.
* Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
7 Years
25 Years
ALL
No
Sponsors
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Children's Hospital of Philadelphia
OTHER
Stanford University
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Lynda Schneider
Professor, Harvard Medical School
Principal Investigators
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Lynda C Schneider, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Andrew MacGinnitie, MD, PhD
Role: STUDY_CHAIR
Children' Hospital Boston
Kari Nadeau, MD, PhD
Role: STUDY_CHAIR
Stanford University
Jonathan Spergel, MD, PhD
Role: STUDY_CHAIR
Children's Hospital of Philadelphia
Jacqueline Pongracic, MD
Role: STUDY_CHAIR
Lurie Children's Hospital
Locations
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Stanford University
Stanford, California, United States
Lurie Children's Hospital
Chicago, Illinois, United States
Division of Immunology, Children's Hospital Boston
Boston, Massachusetts, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Chen G, Shrock EL, Li MZ, Spergel JM, Nadeau KC, Pongracic JA, Umetsu DT, Rachid R, MacGinnitie AJ, Phipatanakul W, Schneider L, Oettgen HC, Elledge SJ. High-resolution epitope mapping by AllerScan reveals relationships between IgE and IgG repertoires during peanut oral immunotherapy. Cell Rep Med. 2021 Oct 19;2(10):100410. doi: 10.1016/j.xcrm.2021.100410. eCollection 2021 Oct 19.
Other Identifiers
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Peanut 002
Identifier Type: -
Identifier Source: org_study_id
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