Boiled Peanut Oral Immunotherapy

NCT04090203 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: BPOIT 18-1294
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Peanut Hypersensitivity

Keywords

Peanut; Allergy

Outcome Measures

Primary Outcomes (1)

• Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.

  The percentage of patients able to consume a single dose of 300 mg or greater of peanut protein with no dose limiting symptoms at exit food challenge are considered 'successfully desensitized'. Any enrolled participants who did not tolerate the 300 mg dose or did not complete the exit food challenge for any reason are considered not successfully desensitized. The percentage of successfully desensitized participants is presented with corresponding lower bound of the one-sided 95% CI, calculated as the lower bound of a two-sided 90% exact confidence interval.

  18 weeks

Study Arms (1)

Boiled Peanut Powder

EXPERIMENTAL

Boiled Peanut Powder

Drug: Boiled Peanut Powder

Interventions

Boiled Peanut Powder DRUG

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.

Also known as: Immunotherapy

Boiled Peanut Powder

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Alton Melton: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity; Hypersensitivity

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Limitations and Caveats

Enrollment was paused due to institutional IRB regulations during the COVID-19 pandemic. After resumption of enrollment, the study proceeded as planned.

Results Point of Contact

• Title: Dr. Jaclyn Bjelac
• Organization: Cleveland Clinic

bjelacj2@ccf.org

216 445-1449

Study Officials

• Jaclyn Bjelac, MD

  Staff

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Prospective open label phase I

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: September 16, 2019
• Study Start: November 5, 2019
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)