Clinical trial NCT04090203: Boiled Peanut Oral Immunotherapy
Official title: Boiled Peanut Oral Immunotherapy for the Treatment of Peanut Allergic Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peanut Hypersensitivity
Keywords: Peanut
Allergy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2019-09-16
Enrollment: 8
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective open label phase I
Primary purpose: TREATMENT

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%.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in Tolerance to Peanut in Pediatric Patients With Peanut Hypersensitivity Reported as the Percentage of Participants Successfully Desensitized.
timeFrame: 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Staff
name: Jaclyn Bjelac, MD
role: PRINCIPAL_INVESTIGATOR
References: