Overview

This trial is active, not recruiting.

Condition peanut hypersensitivity
Treatments peanut oral immunotherapy, omalizumab
Phase phase 1/phase 2
Sponsor University of North Carolina, Chapel Hill
Collaborator Genentech
Start date July 2009
End date July 2015
Trial size 10 participants
Trial identifier NCT00932282, 00015541

Summary

The purpose of this study is to determine whether the addition of anti-IgE treatment will make peanut oral immunotherapy safer, more tolerable, and more effective in treating peanut allergy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Randomized subjects who will stay on the maintenance dose of oral peanut immunotherapy for 12 months.
peanut oral immunotherapy Xolair
Peanut flour taken by mouth, given every day. Dose ranges from 0.2mg of peanut flour to 8000mg of peanut flour during the maintenance phase.
omalizumab Xolair
Omalizumab (anti-IgE) will be given for 4 months prior to starting oral immunotherapy. The medication is given as a subcutaneous injection with dose based on total IgE levels and weight at the beginning of the study. This medication is given for a total of 10 months.
(Active Comparator)
Randomized subjects who will stay on the maintenance dose of peanut oral immunotherapy for 24 months.
peanut oral immunotherapy Xolair
Peanut flour taken by mouth, given every day. Dose ranges from 0.2mg of peanut flour to 8000mg of peanut flour during the maintenance phase.
omalizumab Xolair
Omalizumab (anti-IgE) will be given for 4 months prior to starting oral immunotherapy. The medication is given as a subcutaneous injection with dose based on total IgE levels and weight at the beginning of the study. This medication is given for a total of 10 months.

Primary Outcomes

Measure
The percentage of subjects who pass the 20gm peanut flour (~50% peanut protein) oral food challenge following the desensitization phase of the study
time frame: 2 or 3 years

Secondary Outcomes

Measure
Incidence of side effects during initial escalation and build up phase
time frame: Every 6 months

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Age 12 years and above of either sex, any race, any ethnicity at the time of the initial visit - The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 5 kUA/L - A history of significant clinical symptoms (urticaria, angioedema, rhinorrhea, nasal congestion, pruritis, sneezing, abdominal pain, emesis, diarrhea, wheezing, shortness of breath, lip/tongue swelling, throat itching, throat swelling, impending sense of doom) occurring within 60 minutes after ingesting peanuts - Provide signed informed consent - Women who are sexually active, must agree to use appropriate contraceptive measures for the duration of the study and for 9 months afterwards Exclusion Criteria: - History of severe anaphylaxis to peanut or omalizumab as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence) - Currently participating in a study using an investigational new drug - Participation in any interventional study for the treatment of food allergy in the past 12 months - Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded - Poor control or persistent activation of atopic dermatitis - Moderate to severe persistent asthma - Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines - Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs) - History of other serious underlying disease (i.e., heart disease, diabetes, etc.) - Women who are pregnant or nursing

Additional Information

Official title Peanut Oral Immunotherapy and Anti-IgE for Peanut Allergy
Principal investigator Wesley Burks, MD
Description The goal of this proposal is to produce a new treatment that would benefit subjects who have peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study if peanut oral immunotherapy (OIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance. This study will augment other ongoing studies by looking at whether anti-IgE therapy can reduce side effects and allow for an accelerated build up phase. Peanut allergic patients greater than 12 years old will undergo omalizumab (anti-IgE) treatment for 4 months prior to peanut OIT, and they will continue omalizumab until one month after maintenance therapy. Each subject will have an initial desensitization phase over 2 days to a goal of 950 mg of peanut powder followed by a build up phase over 4 months to goal maintenance dose of 8000 mg peanut powder. They will be randomized to continue maintenance for 12 or 24 months. They will then have an oral food challenge (OFC) immediately after stopping peanut OIT to test for desensitization. Four weeks later, off OIT, another food challenge will be done to assess tolerance. Outcome variables of interest include results of the OFCs, pre and post skin tests, CAP-FEIA values and basophil studies. These results will be compared between the starting point and the patient at the end of the study using appropriate statistical analysis.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.