Peanut AllergyNCT04222491
Food Oral Immunotherapy for Peanut Allergy
An observational study of Peanut Allergy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Peanut oral immunotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult individuals with food allergy as specified in the eligibility criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Peanut Allergy
- Being tested
- Peanut oral immunotherapy
- Keywords
- food allergy
- Medical subject headings
- Peanut Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut oral immunotherapyDrug
Also called Peanut flour, Peanut allergen powder
Peanut oral immunotherapy for peanut allergy
| Study group | Role | What they receive |
|---|---|---|
| active peanut OIT | active peanut oral immunotherapy Receives: Drug: Peanut oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (5)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start25 Jun 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne G. Shreffler, MD, PhD, Massachusetts General Hospital
- Investigators
- Wayne G Shreffler, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222491
- Sponsor's protocol ID
- 2019P003564
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2020
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Clinical Food Oral Immunotherapy for Peanut Allergy
- ClinicalTrials.gov ID
- NCT04222491
- Acronym / sponsor ID
- 2019P003564
- Conditions
- Peanut Allergy
- Keywords
- food allergy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active peanut OIT | – | Drug: Peanut oral immunotherapyactive peanut oral immunotherapy |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult individuals with food allergy as specified in the eligibility criteria.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peanut oral immunotherapyAlso: Peanut flour, Peanut allergen powderPeanut oral immunotherapy for peanut allergy | Drug | active peanut OIT |
Primary outcome
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT
Time frame: 2 years
Feasibility analysis as assessed by the proportion of participants who tolerate the maintenance dose in a dichotomous manner
5 secondary outcomes
Change in quality of life scores from baseline to end of treatment
Time frame: 4 years
Change in peanut specific serum immunoglobulin E (IgE) from baseline to end of treatment
Time frame: 4 years
Change in skin prick test reactivity to peanut extract from baseline to end of treatment
Time frame: 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
Time frame: 4 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne G Shreffler, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peanut Allergy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.