NCT02203799

Peanut Oral Immunotherapy in Children With Peanut Allergy (Peanut Flour)

Immune Responses in Peanut Allergic Subjects Undergoing Peanut Oral Immunotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Many children who are allergic to peanuts do not outgrow their allergy and have very severe allergic reactions called anaphylaxis. Symptoms of anaphylaxis include difficulty breathing, decreased blood pressure, hives, and lip or throat swelling after exposure to an allergen. A severe allergic reaction can lead to death if not treated appropriately. The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts. The approach that will used for this study is a process called "desensitization". Oral immunotherapy involves eating gradually increasing amounts of a food over several months. This is a research study because at this time peanut oral immunotherapy (OIT) is investigational. Peanut OIT (study drug) is investigational because it is not currently approved for clinical use by the Food and Drug Administration. There are no alternative safe and effective treatments for peanut induced allergic reactions other than peanut avoidance and treatment with medications.

Detailed description

This is a phase I, open label study for the initial 12 month desensitization phase of peanut oral immunotherapy and a 2 year maintenance phase. Subjects will be recruited to determine the immune response during the administration of peanut OIT after the development of disease. Cohort will include children age 5-16 years who have peanut allergy. The study will require approximately 36 visits with 3 phases: screening phase (\~ 2 months); build-up phase (weeks 1 year), followed by the maintenance phase (2 years). The primary objective of the OIT protocol is to desensitize subjects to peanut and this occurs over the first 12 months of the study (build-up phase). The first dose will be based on the amount at which the subject reacted during a double blind placebo controlled food challenge (DBPCFC). Thereafter, dose escalation would continue as outlined in the protocol for approximately 50 weeks until the maintenance dose of peanut protein (3900 mg) is reached. The maintenance phase will continue from the end of the build-up phase until approximately 24 months. During this phase, the subject will switch to a peanut equivalent dose for the maintenance phase. At the conclusion of the maintenance phase a DBPCFC will be done. Negative challenges will be confirmed by open challenge. DBPCFC will be done.

Conditions

• Peanut Allergic Subjects

Interventions

Type	Name	Description
BIOLOGICAL	Peanut Oral Immunotherapy (POIT)	The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.

Timeline

• Start date: 2014-07-31
• Primary completion: 2020-02-11
• Completion: 2020-02-11
• First posted: 2014-07-30
• Last updated: 2024-01-19
• Results posted: 2024-01-19

Locations

1 site across 1 country: United States