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

NCT01781637 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-21

Study results available
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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

Interventions

DRUG

Omalizumab

subcutaneous injection

DRUG

placebo

subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Lynda C Schneider, MD · Boston Children's Hospital

  • Andrew MacGinnitie, MD, PhD · Children' Hospital Boston

  • Kari Nadeau, MD, PhD · Stanford University

  • Jonathan Spergel, MD, PhD · Children's Hospital of Philadelphia

  • Jacqueline Pongracic, MD · Lurie Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-10-31
Completion
2022-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01781637 on ClinicalTrials.gov