A Safety and Efficacy Study of Xolair in Peanut Allergy
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
6 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The patient has a diagnosis of acute peanut allergy
The patient meets the Xolair dosing table eligibility criteria by having a serum baseline IgE level between 30 and 1300IU/mL, and a body weight between 20 and 150 kilograms
The patient is six to 75 years of age
The patient reacts to peanut flour but not wheat (placebo) flour during the first Oral Food Challenge (OFC)
The patient has a positive skin prick test to peanut or detectable serum peanut-specific IgE level
The patient is able to swallow capsules
Have FEV1 value <80% predicted or any clinical features of moderate persistent asthma, as defined by the NHLBI guidelines
Have other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
Have a history of allergy to wheat protein
Have previously been exposed to monoclonal antibody treatment