Food Oral Immunotherapy for Peanut Allergy

Outcomes of Clinical Food Oral Immunotherapy for Peanut Allergy

This is an open label observational single center study of clinical food oral immunotherapy outcomes with biomarker samples and participant and/or caregiver-completed questionnaires in participants between 6 months and 65 years of age with IgE-mediated peanut allergy undergoing food oral immunotherapy.

Study Overview

• Status: Enrolling by invitation
• Conditions: Peanut Allergy
• Intervention / Treatment: Drug: Peanut oral immunotherapy

Detailed Description

In this research study the investigators want to learn more about the experience of participants with peanut allergy and their caregivers undergoing food oral immunotherapy (OIT) for peanut allergy. Food oral immunotherapy (OIT) is a treatment for individuals with a food allergy to reduce the body's allergic response to the food allergen, resulting in fewer symptoms. The treatment is also called desensitization. An individual becomes desensitized to the food allergen by ingesting small amounts of the food that are slowly increased. Over time, this helps the body's immune system become used to the food so that it no longer causes an allergic reaction. By desensitizing to peanut, it may lower the risk of life-threatening allergic reactions and cause a decreased sensitivity to peanut. The investigators specifically want to learn more about the effects of food OIT on quality of life and other outcomes important to participants with peanut allergy and their caregivers and to ultimately develop tests to predict who may respond favorably to food OIT.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals between 6 months and 65 years of age with a diagnosis of immunoglobulin E (IgE)-mediated peanut allergy and their caregivers; a diagnosis of IgE-mediated peanut allergy is defined by: (1) documented history of peanut allergy or determined to be allergic by oral food challenge; (2) evidence of peanut-specific IgE by either: positive skin prick test to peanut allergen (reaction wheal at least 3 mm larger than saline control) or serum peanut-specific IgE > 0.34 kilo-unit/liter (kU/L) or international unit/milliliter (IU/mL) at screening visit
• Referral by Massachusetts General Hospital (MGH) allergist for food oral immunotherapy
• Willing to sign informed consent or whose caregiver is willing to sign the informed consent (age appropriate)
• Willing to sign the assent form, if age appropriate

Exclusion Criteria:

• History of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening
• Severe or poorly controlled asthma
• Diagnosis of other severe or complicating medical problems, including autoimmune or chronic immune inflammatory conditions or gastrointestinal inflammatory conditions, such as inflammatory bowel diseases and eosinophilic gastrointestinal disorders
• Current use of beta blocker medication(s)
• Inability to cooperate with and/or perform oral food challenge procedures
• Females who are pregnant, planning to become pregnant, or breastfeeding
• Investigator determination of safety concern for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active peanut OIT; active peanut oral immunotherapy	Drug: Peanut oral immunotherapy; Peanut oral immunotherapy for peanut allergy; Other Names: Peanut flour; Peanut allergen powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT	Feasibility analysis as assessed by the proportion of participants who tolerate the maintenance dose in a dichotomous manner	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life scores from baseline to end of treatment	Change in quality of life scores from baseline assessment to end of treatment assessment using the Food Allergy Quality of Life Questionnaire (FAQLQ) total score. The FAQLQ total and domain scores range from 1-7 where 1 was the best possible score (i.e. fewest problems or better health related quality of life) and with the total score being the average of the domain scores. The domains include Emotional Impact, Social and Dietary Restrictions, and Food Anxiety.	4 years
Change in peanut specific serum immunoglobulin E (IgE) from baseline to end of treatment	Change in peanut specific serum immunoglobulin E (IgE) [in kilo-units per liter (kU/L) or international units per milliliter (IU/mL)] from baseline to end of treatment	4 years
Change in skin prick test reactivity to peanut extract from baseline to end of treatment	Change in skin prick test wheal diameter measurement in millimeters to peanut extract from baseline to end of treatment	4 years
The proportion of participants who tolerate a cumulative dose of 5000 mg peanut protein on oral food challenge without treatment after 12 months on maintenance dose	Desensitization to peanut as assessed by cumulative tolerated dose	4 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Safety analysis as assessed by patient-reported or observed allergic symptoms that will be analyzed and tabulated	4 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Wayne G Shreffler, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 7, 2020
• First Posted (Actual): January 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: food allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: 2019P003564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No