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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
Referral by Massachusetts General Hospital (MGH) allergist for food oral immunotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will observe the outcomes of oral immunotherapy for peanut allergy, collecting blood samples and participant-reported data.

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.Check my eligibility
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.See study design
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.
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I was referred by an MGH allergist for food allergy treatment.
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I am willing to sign the consent form if I am of the appropriate age.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT
Secondary outcome measures
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

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
~60

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,920 Previous Clinical Trials
13,192,808 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial accommodate individuals aged fifty or above?

"According to this trial's eligibility requirements, the oldest possible participant is 65 years old and the youngest must be at least 6 months of age."

Answered by AI

Is enrollment still available for this clinical research endeavor?

"This investigation, which was started on June 25th 2020 and last updated May 3rd 2021 is not currently enrolling participants. However, there are 259 other clinical investigations actively recruiting at this moment in time."

Answered by AI

How risky is Peanut oral immunotherapy for individuals?

"While there is no data supporting the efficacy of peanut oral immunotherapy, there are safety studies already conducted that earned this drug a score of 2."

Answered by AI

Would I be considered a suitable participant in this research?

"This peanut allergy trial is searching for 500 participants between the ages of 6 months and 65 years. In addition to meeting these age requirements, potential patients must also be willing to sign an assent form (if applicable)."

Answered by AI
~119 spots leftby Jun 2025