Clinical trial NCT01781637: Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Official title: Phase 2 Study of Omalizumab in Oral Peanut Desensitization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peanut Allergy
Food Allergy
Keywords: Xolair
omalizumab
peanut
oral desensitization
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Stanford University
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2013-02-01
Enrollment: 36
Sex: ALL
Minimum age (years): 7
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Detailed description: 36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.

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.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
* 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:

* Subjects with a total IgE at screening of \< 50 kU/L \> 2,000 kU/L.
* 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.

Primary outcomes:
measure: Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
timeFrame: 6 weeks after last dose of omalizumab/placebo
Secondary outcomes:
measure: Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
timeFrame: 12 weeks after last dose of omalizumab/placebo
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Boston
country: United States
facility: Division of Immunology, Children's Hospital Boston
state: Massachusetts
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Boston Children's Hospital
name: Lynda C Schneider, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children' Hospital Boston
name: Andrew MacGinnitie, MD, PhD
role: STUDY_CHAIR
affiliation: Stanford University
name: Kari Nadeau, MD, PhD
role: STUDY_CHAIR
affiliation: Children's Hospital of Philadelphia
name: Jonathan Spergel, MD, PhD
role: STUDY_CHAIR
affiliation: Lurie Children's Hospital
name: Jacqueline Pongracic, MD
role: STUDY_CHAIR
References:
citation: 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.