Food Oral Immunotherapy for Peanut Allergy

• Status: Enrolling by invitation
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Immunologic Factors

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