A Phase 2 Randomized, Controlled, Blinded Study Omalizumab With Oral Food Immunotherapy in Children and Adults With Multiple Food Allergies
To develop a potentially curative therapy for patients with multi food allergy.We hypothesize that study subjects with multi food allergy who receive a combination of amalizumab and multi oral food therapy (OIT) can be rapidly desensitized and tolerate higher doses of food with fewer overall reactions than those who receive placebo and OIT.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2 Randomized, Controlled, Blinded Study in a Single Center Using Omalizumab With Oral Food Immunotherapy in Children and Adults With Multiple Food Allergies|
- Number of omalizumbab treated subjects who have the ability to tolerate an oral dose of 4000mg of each food protein 6 weeks after discontinuing omalizumab. [ Time Frame: Week 25 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||February 2017 (Final data collection date for primary outcome measure)|
Active Comparator: omalizumab
45 pts will receive study drug. Study drug will be dosed per Genentech Global Dosing schedule.
Xolair will be randomized to 45 participants, and 15 pts will receive placebo.
Other Name: xolair
Placebo Comparator: placebo
15 pts will receive placebo study drug, 45 will receive omalizumbab
Our phase 1 study results show that multiple oral immunotherapy given in the same method with omalizumab can be safe and show trends towards efficacy (attachment 3). Therefore, a phase 2 randomized, controlled, blinded study has been proposed to further test safety and efficacy in a larger group of subjects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02062814
|Contact: Tina Dominguez, PAfirstname.lastname@example.org|
|United States, California|
|Stanford Alliance for Food Allergy Research||Recruiting|
|Mountain View, California, United States, 94040|
|Principal Investigator: Kari Nadeau, MD PhD|
|Principal Investigator:||Kari Nadeau, MD PhD||Stanford University|