Boiled Peanut Oral Immunotherapy

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

November 5, 2019

Primary Completion Date

May 20, 2021

Study Completion Date

May 20, 2021

Conditions
Peanut Hypersensitivity
Interventions
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.

Trial Locations (1)

44195

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
collaborator

The Cleveland Clinic

OTHER

lead

Alton Melton

OTHER

NCT04090203 - Boiled Peanut Oral Immunotherapy | Biotech Hunter | Biotech Hunter