Phase 2
N=36
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Peanut Allergy · Food Allergy
Bottom Line
View on ClinicalTrials.gov: NCT01781637 ↗Enrolled (actual)
36
Serious AEs
19.4%
Results posted
May 2017
Primary outcome: Primary: Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo — 23; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Omalizumab (Drug); placebo (Drug)
- Age
- Pediatric, Adult · 7+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo |
23; 1 | — |
| SECONDARY Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo |
20; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.
- Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater)
- ImmunoCAP IgE level to peanut > 10 kU/L.
- Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Exclusion Criteria
- Subjects with a total IgE at screening of 2,000 kU/L.
- Positive reaction to the placebo on DBPCFC.
- Previous reaction to omalizumab.
- Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
Data sourced from ClinicalTrials.gov (NCT01781637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.