Food Oral Immunotherapy for Peanut Allergy

NCT04222491 | Active Not Recruiting DMC FDA Drug

• 1 other identifier: 2019P003564
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peanut Allergy

Keywords

food allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in quality of life scores from baseline to end of treatment

  4 years

• Change in peanut specific serum immunoglobulin E (IgE) from baseline to end of treatment

  4 years

• Change in skin prick test reactivity 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

  4 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  4 years

Study Arms (1)

active peanut OIT

active peanut oral immunotherapy

Drug: Peanut oral immunotherapy

Interventions

Peanut oral immunotherapy DRUG

Peanut oral immunotherapy for peanut allergy

Also known as: Peanut flour, Peanut allergen powder

active peanut OIT

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult individuals with food allergy as specified in the eligibility criteria.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Wayne G Shreffler, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 10, 2020
• Study Start: June 25, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)