Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy

NCT00932282 | Completed Phase 1 Results DMC

• 1 other identifier: 11-2306
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Peanut Hypersensitivity

Keywords

Peanut; Allergy; Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge 2-4 Weeks After Discontinuing Peanut OIT Therapy

  The primary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy is able to induce clinical tolerance as measured by passing an oral food challenge to 20 grams of peanut flour, 2-4 weeks after discontinuing peanut OIT therapy

  approximately 24 or 36 months

Secondary Outcomes (4)

• The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour.

  4 months

• The Percentage of Subjects Who Pass the 20gm Peanut Flour (~50% Peanut Protein) Oral Food Challenge Following the Desensitization Phase of the Study

  approximately 24 or 36 months

• Incidence of All Serious Adverse Events During the Study

  approximately 24 or 36 months

• Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy

  approximately 24 or 36 months

Study Arms (2)

12 month maintenance of PnOIT

ACTIVE COMPARATOR

Randomized subjects who will stay on the maintenance dose of oral peanut immunotherapy (PnOIT) for 12 months. The study has 4 phases: anti-IgE therapy before immunotherapy (Omalizumab), an initial desensitization day(s), a buildup period, and a daily home maintenance phase with a final dose of 8000mg peanut flour (\~50% peanut protein). Then all subjects will be randomized to an additional 1 or 2 years (12 or 24 months) of maintenance OIT. An OFC will be performed at the end of the long-term maintenance in all groups.

Drug: Peanut Oral Immunotherapy; Drug: Omalizumab

24 month maintenance of PnOIT

ACTIVE COMPARATOR

All subjects will be on the same intervention until Randomization. Randomized subjects who will stay on the maintenance dose of peanut oral immunotherapy (PnOIT) for 24 months. The study has 4 phases: anti-IgE therapy before immunotherapy (Omalizumab), an initial desensitization day(s), a buildup period, and a daily home maintenance phase with a final dose of 8000mg peanut flour (\~50% peanut protein). Then all subjects will be randomized to an additional 1 or 2 years (12 or 24 months) of maintenance OIT. An OFC will be performed at the end of the long-term maintenance in all groups.

Drug: Peanut Oral Immunotherapy; Drug: Omalizumab

Interventions

Peanut Oral Immunotherapy DRUG

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.

Also known as: PnOIT

12 month maintenance of PnOIT; 24 month maintenance of PnOIT

Omalizumab DRUG

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.

Also known as: Xolair

12 month maintenance of PnOIT; 24 month maintenance of PnOIT

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; 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: Edwin Kim, Director UNC Food Allergy Initiative
• Organization: University of North Carolina at Chapel Hill

edwinkim@email.unc.edu

919-843-9087

Study Officials

• Wesley Burks, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: July 3, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 1, 2018
• Results First Posted: September 26, 2017

Record last verified: 2015-10

Locations

US (1)