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xolair for Food Allergy (MAP-X Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks
Awards & highlights

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\*.

Eligible Conditions
  • Food Allergy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Desensitization Measured by Proportion of Food Allergic (FA) Participants Who Pass a DBPCFC to 2,000 mg Protein for Each of 2 Allergens at Week 36
Secondary outcome measures
Desensitization Measured to Increased Doses Measured by Proportion of FA Participants Who Pass a DBPCFC to 4,000 mg Each of 2 Allergens at Week 36

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: xolairActive Control1 Intervention
Pts will be randomized to receive xolair at a 3 active:1 placebo ratio
Group II: PlaceboPlacebo Group1 Intervention
This is a placebo that looks similar to Xolair and is given as a subcutaneous shot, just like Xolair

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,346 Total Patients Enrolled
7 Trials studying Food Allergy
1,482 Patients Enrolled for Food Allergy
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,302 Previous Clinical Trials
5,501,394 Total Patients Enrolled
11 Trials studying Food Allergy
12,408 Patients Enrolled for Food Allergy
Kari Nadeau, MD PhDStudy DirectorStanford University
1 Previous Clinical Trials
312 Total Patients Enrolled
~5 spots leftby Sep 2025
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