Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Trial ID or NCT#
NCT01781637
Status
NOT RECRUITING
Purpose
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.
Official Title
Phase 2 Study of Omalizumab in Oral Peanut Desensitization
Eligibility Criteria
Ages Eligible for Study: 7 Years to 25 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 < 50 kU/L > 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.
Contact us to find out if this trial is right for you.
Contact
Sue Neale-May, RN
650-723-5227
View on ClinicalTrials.gov
