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Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (PRROTECT)

Primary Purpose

Peanut Allergy, Food Allergy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omalizumab
placebo
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Xolair, omalizumab, peanut, oral desensitization

Eligibility Criteria

7 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University
  • Lurie Children's Hospital
  • Division of Immunology, Children's Hospital Boston
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

omalizumab group

placebo

Arm Description

Patients will receive omalizumab.

Patients will receive placebo.

Outcomes

Primary Outcome Measures

Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo

Secondary Outcome Measures

Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo

Full Information

First Posted
January 30, 2013
Last Updated
February 16, 2023
Sponsor
Boston Children's Hospital
Collaborators
Children's Hospital of Philadelphia, Stanford University, Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01781637
Brief Title
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Acronym
PRROTECT
Official Title
Phase 2 Study of Omalizumab in Oral Peanut Desensitization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Children's Hospital of Philadelphia, Stanford University, Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy, Food Allergy
Keywords
Xolair, omalizumab, peanut, oral desensitization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
omalizumab group
Arm Type
Experimental
Arm Description
Patients will receive omalizumab.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Other Intervention Name(s)
Xolair
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
Time Frame
6 weeks after last dose of omalizumab/placebo
Secondary Outcome Measure Information:
Title
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
Time Frame
12 weeks after last dose of omalizumab/placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynda C Schneider, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew MacGinnitie, MD, PhD
Organizational Affiliation
Children' Hospital Boston
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kari Nadeau, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jonathan Spergel, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jacqueline Pongracic, MD
Organizational Affiliation
Lurie Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Division of Immunology, Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34755130
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.
Results Reference
derived

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Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

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