Trial ID or NCT#

NCT03679676

Status

recruiting iconRECRUITING

Purpose

Food allergy (FA) is a serious public health concern that causes potentially-life threatening reactions in affected patients. The prevalence of food allergy in the United States (U.S.) has increased substantially and now affects 15 million patients:4-8% of children (6 million children, 30% with multiple food allergies) and about 9% of adults. This is a prospective Phase 2, single-center, multi-allergen OIT study in participants with proven allergies to 2 or 3 different foods in which one must be a peanut. The total of participants in the clinical study will be 110, ages 5 to 55 years with a history of multiple food allergies of 2 to 3 different foods including peanut. Allergy will be confirmed by FA-specific IgE levels and positive skin prick test (SPT). Enrolled participants must be positive during the Double-blind Placebo-controlled Food challenge (DBPCFC) at or before the 300 mg (444 mg cumulative) dosing level of FA proteins.

Official Title

Phase 2 Randomized Controlled Trial Using Biologics to Improve Multi OIT Outcomes

Eligibility Criteria

Ages Eligible for Study: 5 Years to 55 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Kari Nadeau, MD, PhD
Kari Nadeau, MD, PhD
Allergist, Asthma specialist, Immunologist, Pediatrician
Naddisy Foundation Professor of Pediatric Food Allergy, Immunology and Asthma, Professor of Pediatrics, Senior Fellow at the Woods Institute and Professor, by courtesy, of Otolaryngology and of Epidemiology and Population Health
R. Sharon Chinthrajah
R. Sharon Chinthrajah
Allergist, Immunologist, Pulmonologist
Associate Professor of Medicine (Pulmonary and Critical Care Medicine)

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CONTACT

SNP Center Inquiry
(650) 521-7237