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

NCT01781637 | Completed Phase 1 Results DMC

• 1 other identifier: Peanut 002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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.

Conditions

Peanut Allergy; Food Allergy

Keywords

Xolair; omalizumab; peanut; oral desensitization

Outcome Measures

Primary Outcomes (1)

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

  6 weeks after last dose of omalizumab/placebo

Secondary Outcomes (1)

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

  12 weeks after last dose of omalizumab/placebo

Study Arms (2)

omalizumab group

EXPERIMENTAL

Patients will receive omalizumab.

Drug: Omalizumab

placebo

PLACEBO COMPARATOR

Patients will receive placebo.

Drug: placebo

Interventions

Omalizumab DRUG

subcutaneous injection

Also known as: Xolair

omalizumab group

placebo DRUG

subcutaneous injection

placebo

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Children's Hospital of Philadelphia: collaborator
• Stanford University: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Division of Immunology, Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 34755130 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Lynda Schneider
• Organization: Boston Children's Hospital

lynda.schneider@childrens.harvard.edu

617-355-6180

Study Officials

• Lynda C Schneider, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Andrew MacGinnitie, MD, PhD

  Children' Hospital Boston

  STUDY CHAIR

• Kari Nadeau, MD, PhD

  Stanford University

  STUDY CHAIR

• Jonathan Spergel, MD, PhD

  Children's Hospital of Philadelphia

  STUDY CHAIR

• Jacqueline Pongracic, MD

  Lurie Children's Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Harvard Medical School

Study Record Dates

• First Submitted: January 30, 2013
• First Posted: February 1, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: May 31, 2022
• Last Updated: February 21, 2023
• Results First Posted: May 3, 2017

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)