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Peanut allergy treatment shows promise in large study

NCT ID NCT04222491

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 500 people aged 6 months to 65 years with peanut allergy who are undergoing peanut oral immunotherapy. The goal is to see how many can tolerate a maintenance dose of 300 mg of peanut protein without symptoms within two years. Researchers also track changes in quality of life. The treatment involves eating small, increasing amounts of peanut flour to build tolerance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peanut flour (peanut allergen powder)
What this could lead to
If successful, this could show that oral immunotherapy helps many people with peanut allergy safely tolerate small amounts of peanut, reducing the risk of severe reactions from accidental exposure.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. Some participants may still have allergic reactions during treatment, and the maintenance dose is very small—not a cure or full tolerance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

6 months to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

food allergy Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peanut allergy

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.