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Immunotherapy

Oral Immunotherapy for Peanut Allergy

Phase 2
Waitlist Available
Led By Wayne G Shreffler, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Current use of beta blocker medication(s)
Females who are pregnant, planning to become pregnant, or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies how gradually eating small amounts of peanut can help people with peanut allergies reduce their allergic reactions. It focuses on individuals aged 6 months to 65 years and aims to improve their quality of life and predict who will benefit most from this treatment. A specific preparation of peanut allergen was approved for younger patients with a peanut allergy.

Who is the study for?
This trial is for individuals aged 6 months to 65 years with a confirmed IgE-mediated peanut allergy, or those who have had a reaction to peanuts and show specific immune responses in tests. Participants must be referred by an MGH allergist and willing (or their caregivers) to consent. It's not for those with recent severe allergic reactions, uncontrolled asthma, certain chronic conditions, current beta blocker use, or pregnant/breastfeeding women.
What is being tested?
The study is testing the outcomes of peanut oral immunotherapy—a treatment where people with peanut allergies are given small amounts of peanut protein to build up tolerance. The process includes biomarker sampling and questionnaires from participants or caregivers.
What are the potential side effects?
While not explicitly listed here, typical side effects of food oral immunotherapy can include itching in the mouth, mild nausea or stomach discomfort, hives, wheezing, and potentially more serious allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I or my child have a confirmed peanut allergy through tests or history.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking beta blocker medication.
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I am pregnant, planning to become pregnant, or breastfeeding.
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My asthma is severe or not well-controlled.
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I have severe health issues like autoimmune or chronic inflammatory conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT
Secondary study objectives
Change in peanut specific serum immunoglobulin E (IgE) from baseline to end of treatment
Change in quality of life scores from baseline to end of treatment
Change in skin prick test reactivity to peanut extract from baseline to end of treatment
+2 more

Side effects data

From 2017 Phase 2 trial • 37 Patients • NCT00932828
78%
Rash (not hives)
62%
Nausea/vomiting
59%
Abdominal pain
54%
Hives
51%
Skin/oral pruritus
35%
Sneezing/congestion
30%
Multiple symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Peanut Oral Immunotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: active peanut OITExperimental Treatment1 Intervention
active peanut oral immunotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peanut oral immunotherapy
2009
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,308,811 Total Patients Enrolled
Wayne G Shreffler, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
5 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Peanut Oral Immunotherapy (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04222491 — Phase 2
Peanut Allergy Research Study Groups: active peanut OIT
Peanut Allergy Clinical Trial 2023: Peanut Oral Immunotherapy Highlights & Side Effects. Trial Name: NCT04222491 — Phase 2
Peanut Oral Immunotherapy (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04222491 — Phase 2
~51 spots leftby Jun 2025
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