Boiled Peanut Oral Immunotherapy

Peanut Hypersensitivity Clinical Trial

— BPOIT  

Official title:

Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04090203
• Other study ID #: BPOIT 18-1294
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 5, 2019
• Est. completion date: August 20, 2023

Study information

• Verified date: October 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective Phase 1 clinical trial providing proof of concept data on boiled peanut oral immunotherapy (OIT) for the treatment of peanut allergy in children. The investigators hypothesize that the proportion of subjects successfully desensitized with boiled peanut OIT is greater than the theoretical placebo rate of 20%.

Description:

Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. Participants will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. Participants will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit double blind placebo controlled food challenge. At the conclusion of the study, participants will be offered continued maintenance therapy off study in line with current specialty standards.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: August 20, 2023
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Age 1-16 years

• History of immediate hypersensitivity reaction to peanut

• Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment

• SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE >0.35 kU/L

Exclusion Criteria:

• History of life threatening peanut anaphylaxis

• Asthma requiring more than medium dose ICS

• Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy

• Oat allergy

• Cardiovascular Disease

• Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers

• Use of steroid medications in the following manners:

• Daily oral steroid dosing for greater than 1 month during the past year

• Burst or steroid course in the past 3 month before inclusion

• Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration

• Pregnancy or lactation

• Eosinophilic Gastrointestinal Disease

• History of food protein-induced enterocolitis

• History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator

Related Conditions & MeSH terms

• Hypersensitivity
• Peanut Hypersensitivity

Intervention

Drug:
• Boiled Peanut Powder
Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alton Melton	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in tolerance to peanut in pediatric patients with peanut hypersensitivity.	The investigator will compare the proportion of patients successfully desensitized as defined by meeting the primary endpoint with the expected placebo rate. The null hypothesis is that the proportion of patients successfully desensitized by boiled peanut oral immunotherapy will not be greater than the expected 20% that has been previously published as the proportion of patients successfully meeting the primary endpoint in OIT studies (which aligns with the expected 20% that would naturally "outgrow" a peanut allergy). If the null hypothesis is rejected, it can be concluded that the proportion of patients successfully desensitized by boiled peanut therapy is greater than placebo.	18 weeks