Peanut Oral Immunotherapy in Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-13

Study Completion Date

2018-12-21

Brief Summary

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This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.

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Detailed Description

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An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:

* Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
* Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
* Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
* Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).

Conditions

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Peanut Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Peanut Oral Immune Therapy (OIT)

Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.

Group Type EXPERIMENTAL

Peanut Oral Immunotherapy - Liquid Extract

Intervention Type BIOLOGICAL

Used during initial dose escalation for doses 0.1 to 0.8 mg.

Peanut Oral Immunotherapy - Peanut Flour

Intervention Type BIOLOGICAL

This will be used for the remainder of dose escalation, build-up, and maintenance.

Peanut Placebo

Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material.

Group Type PLACEBO_COMPARATOR

Placebo for Peanut Oral Immunotherapy - Liquid Extract form

Intervention Type BIOLOGICAL

Similar in appearance, texture, and taste to peanut liquid extract.

Placebo for Peanut Oral Immunotherapy - Peanut Flour

Intervention Type BIOLOGICAL

Similar in appearance, texture, and taste to peanut flour.

Interventions

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Peanut Oral Immunotherapy - Liquid Extract

Used during initial dose escalation for doses 0.1 to 0.8 mg.

Intervention Type BIOLOGICAL

Placebo for Peanut Oral Immunotherapy - Liquid Extract form

Similar in appearance, texture, and taste to peanut liquid extract.

Intervention Type BIOLOGICAL

Peanut Oral Immunotherapy - Peanut Flour

This will be used for the remainder of dose escalation, build-up, and maintenance.

Intervention Type BIOLOGICAL

Placebo for Peanut Oral Immunotherapy - Peanut Flour

Similar in appearance, texture, and taste to peanut flour.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
* Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
* Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
* A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
* Written informed consent from parent/guardian.

Exclusion Criteria

* History of severe anaphylaxis with hypotension to peanut;
* Documented clinical history of allergy to oat;
* Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
* Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
* Active eosinophilic gastrointestinal disease in the past 2 years;
* Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
* Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
* Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
* Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
* Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
* Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
* Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
* Use of any investigational drug in 90 days prior to visit -1;
* Plan to use any investigational drug during the study period;
* The presence of any medical condition that the investigator deems incompatible with participation in the trial.

Minimum Eligible Age

12 Months

Maximum Eligible Age

48 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No