Clinical trial NCT00932282: Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
Official title: Peanut OIT & Anti-IgE: Peanut Oral Immunotherapy and Anti-IgE Treatment for Peanut Allergy {NIH R21 Combined Peanut Oral Immunotherapy and Anti-IgE: Mechanistic Studies}
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peanut Hypersensitivity
Keywords: Peanut
Allergy
Hypersensitivity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2009-07-03
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy
timeFrame: approximately 24 or 36 months
Secondary outcomes:
measure: The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.
timeFrame: 4 months
measure: The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study
timeFrame: approximately 24 or 36 months
measure: Incidence of All Serious Adverse Events During the Study
timeFrame: approximately 24 or 36 months
measure: Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy
timeFrame: approximately 24 or 36 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Wesley Burks, MD
role: PRINCIPAL_INVESTIGATOR
References: