Multi Immunotherapy to Test Tolerance and Xolair

PHASE2CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

November 16, 2016

Study Completion Date

November 16, 2016

Conditions
Food Allergy
Interventions
DRUG

Omalizumab

Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.

DRUG

Food Flour Buildup

Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized.

Trial Locations (7)

10029

Mt. Sinai, Icahn School of Medicine, New York

19104

Children's Hospital of Philadelphia, Philadelphia

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60611

Lurie Children's Hospital, Northwestern University, Chicago

90027

Children's Hospital of Los Angeles, Los Angeles

94040

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

98115

Northwest Asthma & Allergy Center, Seattle

All Listed Sponsors
collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Children's Hospital Los Angeles

OTHER

collaborator

University of Washington

OTHER

lead

Kari Christine Nadeau

OTHER

NCT02626611 - Multi Immunotherapy to Test Tolerance and Xolair | Biotech Hunter | Biotech Hunter