Food Oral Immunotherapy for Peanut Allergy

Peanut Allergy Clinical Trial

Official title:

Outcomes of Clinical Food Oral Immunotherapy for Peanut Allergy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04222491
• Other study ID #: 2019P003564
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 25, 2020
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Drug:
• Peanut oral immunotherapy
Peanut oral immunotherapy for peanut allergy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years
Secondary	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.	4 years
Secondary	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	4 years
Secondary	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	4 years
Secondary	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	4 years
Secondary	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	4 years