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Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

NCT02643862 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-01-12

Study results available
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Summary

This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36\* participants will receive Xolair for 16 weeks while 12\* will receive corresponding placebo instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These 12 controls are not part of the randomization. The total number of participants randomized to the two arms is 48\*.

Conditions

Interventions

DRUG

Xolair

Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Kari Nadeau, MD PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-18
Primary Completion
2016-08-20
Completion
2016-08-20

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02643862 on ClinicalTrials.gov