Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Adults with Food Allergy Needed for Drug Clinical Trial!
Enrollment for this study is expected to close on Thursday, March 5, 2026
Overview
What we are studying
This study is researching an experimental drug when combined with another drug. This study is focused on patients who have severe immunoglobulin E (IgE)‑mediated food allergy. If you have an allergy, your immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergens bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable the two investigational drugs are. Both are antibody-based drugs. Study drug A helps by destroying plasma cells. This study will investigate how much study drug A is needed to eliminate plasma cells that produce the allergen specific IgE. After treatment with study drug A ends, plasma cells will slowly come back. Study drug B blocks certain proteins that are needed to produce IgE. Therefore, this study will also investigate if continuing study drug B treatment after study drug A treatment has ended will help keep IgE levels low. The study drugs are called investigational because they are not yet approved for their use.
Why it is important
Food allergy, an adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a given food, is a potentially life-threatening condition that affects between 10% to 13% of adults in the US and has been increasing in prevalence over the last 2 to 3 decades. There has been considerable interest in treating people with persistent food allergy with therapies that interrupt allergen-specific IgE from eliciting anaphylaxis. Although strides have been made in food allergy awareness and prevention of allergen-specific sensitization, there is no satisfactory therapy to prevent or reverse this disease. Current standard of care for individuals with food allergy is strict avoidance of foods to which they are allergic and quick access to an epinephrine autoinjector at all times.
What we hope to accomplish
By joining this study, you may help us learn things about the study drug(s) that could help other people who have severe IgE-mediated food allergy.
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Principal Investigator
Contact
Click I Am Interested "I Am Interested" "I Am Interested" to get started. If you have questions, contact:
Rodrigo Marin
Who can participate
Participants must be adults ages 18-50 years with a clinical history of documented, ongoing, severe IgE-mediated allergy (with history of anaphylaxis) to one or more of the following foods: peanut, hazelnut, walnut, cashew, milk, egg/egg white, soy, wheat, sesame, cod, salmon, tuna, lobster, crab and/or shrimp. Participants must have a body mass index (BMI) between 18 and 32 kg/m². Please note there are other study inclusion criteria.
Who cannot participate
Participants cannot be pregnant or breastfeeding. Please note there are other study exclusion criteria.
What you may be asked to do
Participants will be asked to come in for a screening visit to determine if they qualify for the study. Patients will be taking investigating treatments for up to 42 weeks. After completing the treatment period, participants will be asked to come in for a safety follow-up visit. Participation includes physical exams with vital signs, electrocardiograms, echocardiograms, breathing tests, blood and urine tests, pregnancy tests, skin prick allergy tests, and overnight hospital stays.
Project activities may include:
- Blood draw
- Injection or IV
- Overnight stay
- Biosample (e.g., saliva, urine, or stool)
- Medication
- Office visit
- Ultrasound
Estimated Time Commitment
20 visits over 54 weeks
What You May Get
Participants will be paid $496 per visit for all visits (except the end of treatment visit), and an additional $242 per visit for overnight visits. If you do not complete the study, for any reason, you will be paid for each study visit you complete.
Location
Massachusetts General Hospital - Translational and Clinical Research Centers
55 Fruit Street, White 12, Boston, MA 02114
Travel
- Accessible by public transportation
- Parking available
- Parking reimbursed
Travel and Parking Details
Participants will be reimbursed for parking at the hospital.
Additional Information
Study Phase
Phase 1: This project studies the safety of a medication or treatment, usually on healthy volunteers. It examines the medication or treatment’s effects on the body and looks for side effects.
Funding Source
- Industry