Phase 2
N=13
Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
Peanut Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT00932282 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy — 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peanut Oral Immunotherapy (Drug); Omalizumab (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy |
3; 1 | — |
| SECONDARY The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour. |
1; 2 | — |
| SECONDARY The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study |
4; 2 | — |
| SECONDARY Incidence of All Serious Adverse Events During the Study |
0; 0 | — |
| SECONDARY Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy |
2.8; 3.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00932282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.