The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

July 25, 2018

Study Completion Date

September 1, 2018

Conditions
Peanut Allergy
Interventions
DRUG

Peanut Protein 4,000mg

"Arm A will be defined as clinically tolerant if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of clinically tolerant will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity."

DRUG

Oat Flour

"Arm C will be defined as natural loss of responsiveness if they show no clinical reactivity at DBPCFCs (week 117 to end of study)."

DRUG

Peanut Protein 300 mg

"Arm B will be defined as desensitized to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study)."

Trial Locations (1)

94040

Sean N. Parker Center for Allergy Research at Stanford University, Mountain View

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Stanford University

OTHER

NCT02103270 - The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery | Biotech Hunter | Biotech Hunter