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Food Oral Immunotherapy for Peanut Allergy

Primary Purpose

Peanut Allergy

Status

Enrolling by invitation

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Peanut oral immunotherapy

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring food allergy

Eligibility Criteria

6 Months - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active peanut OIT

Arm Description

active peanut oral immunotherapy

Outcomes

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

Feasibility analysis as assessed by the proportion of participants who tolerate the maintenance dose in a dichotomous manner

Secondary Outcome Measures

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.

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

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

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

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

Full Information

NCT ID

NCT04222491

First Posted

January 6, 2020

Last Updated

October 17, 2023

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04222491

Brief Title

Food Oral Immunotherapy for Peanut Allergy

Official Title

Outcomes of Clinical Food Oral Immunotherapy for Peanut Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

June 25, 2020 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

food allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

N/A

Enrollment

500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

active peanut OIT

Arm Type

Experimental

Arm Description

active peanut oral immunotherapy

Intervention Type

Drug

Intervention Name(s)

Peanut oral immunotherapy

Other Intervention Name(s)

Peanut flour, Peanut allergen powder

Intervention Description

Peanut oral immunotherapy for peanut allergy

Primary Outcome Measure Information:

Title

The proportion of participants who tolerate the maintenance dose of 300 mg peanut protein with no symptoms within two years of starting OIT

Description

Feasibility analysis as assessed by the proportion of participants who tolerate the maintenance dose in a dichotomous manner

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

4 years

Title

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

Description

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

Time Frame

4 years

Title

Change in skin prick test reactivity to peanut extract from baseline to end of treatment

Description

Change in skin prick test wheal diameter measurement in millimeters to peanut extract from baseline to end of treatment

Time Frame

4 years

Title

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

Description

Desensitization to peanut as assessed by cumulative tolerated dose

Time Frame

4 years

Title

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

Description

Safety analysis as assessed by patient-reported or observed allergic symptoms that will be analyzed and tabulated

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wayne G Shreffler, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Food Oral Immunotherapy for Peanut Allergy

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