Peanut Oral Immunotherapy and Anti-Immunoglobulin E (IgE) for Peanut Allergy - Clinical Trial for Peanut Hypersensitivity | NCT00932282

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Peanut Oral Immunotherapy

Omalizumab

About this trial

This is an interventional treatment trial for Peanut Hypersensitivity focused on measuring Peanut, Allergy, Hypersensitivity

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

12 month maintenance of PnOIT

24 month maintenance of PnOIT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Full Information

NCT ID

NCT00932282

First Posted

June 10, 2009

Last Updated

February 27, 2018

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00932282

Brief Title

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

Acronym

PAIE/Xolair

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

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Hypersensitivity

Keywords

Peanut, Allergy, Hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12 month maintenance of PnOIT

Arm Type

Active Comparator

Arm Description

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.

Arm Title

24 month maintenance of PnOIT

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Peanut Oral Immunotherapy

Other Intervention Name(s)

PnOIT

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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

Time Frame

approximately 24 or 36 months

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 months

Title

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

Description

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.

Time Frame

approximately 24 or 36 months

Title

Incidence of All Serious Adverse Events During the Study

Description

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

Time Frame

approximately 24 or 36 months

Title

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

Description

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

Time Frame

approximately 24 or 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wesley Burks, MD

Organizational Affiliation

University of North Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

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

Peanut Hypersensitivity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial