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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932282
First Posted: July 3, 2009
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
June 10, 2009
July 3, 2009
July 31, 2017
September 26, 2017
September 26, 2017
July 2009
August 2015   (Final data collection date for primary outcome 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 [ Time Frame: approximately 24 or 36 months ]
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
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 ]
Complete list of historical versions of study NCT00932282 on ClinicalTrials.gov Archive Site
  • The Percentage of Subjects Who Tolerate the Initial Desensitization Day(s) to 950mg of Peanut Flour. [ Time Frame: 4 months ]
    A secondary efficacy outcome of the study is to evaluate whether the addition of anti-IgE therapy using Xolair to a peanut oral immunotherapy protocol allows for a higher amount of peanut tolerated after the rush desensitization phase, thereby reducing the duration of buildup phase and achieving maintenance dosing more rapidly
  • 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: approximately 24 or 36 months ]
    A secondary 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 desensitization as measured by passing an oral food challenge to 20 grams of peanut flour on the final day of peanut OIT dosing.
  • Incidence of All Serious Adverse Events During the Study [ Time Frame: approximately 24 or 36 months ]
    A secondary safety outcome of the study is to determine the frequency of SAEs during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of SAEs that occur during oral immunotherapy when compared to previously published results
  • Incidence of Side Effects During Initial Escalation and Build up Phase of Peanut Oral Immunotherapy [ Time Frame: approximately 24 or 36 months ]
    The primary safety outcome of the study is to determine the frequency of side effects during oral immunotherapy in order to assess whether the addition of anti-IgE therapy using Xolair to peanut oral immunotherapy can reduce the number of allergic symptoms that occur during oral immunotherapy when compared to previously published results
Incidence of side effects during initial escalation and build up phase [ Time Frame: Every 6 months ]
Not Provided
Not Provided
 
Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy
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}
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Peanut Hypersensitivity
  • Drug: Peanut Oral Immunotherapy
    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.
    Other Name: PnOIT
  • Drug: Omalizumab
    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.
    Other Name: Xolair
  • Active Comparator: 12 month maintenance of PnOIT

    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.

    Interventions:
    • Drug: Peanut Oral Immunotherapy
    • Drug: Omalizumab
  • Active Comparator: 24 month maintenance of PnOIT

    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.

    Interventions:
    • Drug: Peanut Oral Immunotherapy
    • Drug: Omalizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00932282
11-2306
Yes
Not Provided
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Genentech, Inc.
Principal Investigator: Wesley Burks, MD University of North Carolina
University of North Carolina, Chapel Hill
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP