Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial (PRROTECT)
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.
|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:||Phase 2 Study of Omalizumab in Oral Peanut Desensitization|
- The ability of omalizumab-treated subjects to successfully complete the build-up phase of peanut, and tolerate daily 4,000 mg doses of peanut flour after discontinuing omalizumab. [ Time Frame: 14 wks after the start of oral peanut desensitization (wk 26 of study). ] [ Designated as safety issue: Yes ]
- The ability of subjects to tolerate an oral dose of 4,000 mg peanut. [ Time Frame: 8 wks after the start of oral peanut desensitization (study wk 20). ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: omalizumab group
Patients will receive omalizumab.
Other Name: Xolair
Placebo Comparator: placebo
Patients will receive placebo.
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital.
Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781637
|United States, California|
|Stanford, California, United States, 94305|
|United States, Illinois|
|Lurie Children's Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Massachusetts|
|Division of Immunology, Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Lynda C Schneider, MD||Children's Hospital Boston|
|Study Chair:||Andrew MacGinnitie, MD, PhD||Children' Hospital Boston|
|Study Chair:||Kari Nadeau, MD, PhD||Stanford University|
|Study Chair:||Jonathan Spergel, MD, PhD||Children's Hospital of Philadelphia|
|Study Chair:||Jacqueline Pongracic, MD||Lurie Children's Hospital|