Peanut Allergy Clinical Trial
Official title:
Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell stimulation (CD-sens).
Oral immunotherapy (OIT), where the food protein is consumed in increasing amounts, have been
studied with good results, but allergic reactions has been a major problem. Anti-IgE
antibodies (omalizumab) block allergy antibodies so that the allergic reaction is absent. A
new test in which basophil cells stimulated with allergen in vitro, CD-sens, showing cell
sensitivity, correlates well to peanut challenges.
Twenty children/adolescents, 12 to 22 years, with severe peanut allergy will be treated with
omalizumab and the effect evaluated with CD-sens. If the CD-sens is negative a peanut
challenge will be performed. If the challenge is negative the OIT will start: 1, 2, 4, 8 g
peanuts/day in two-week intervals followed by a maintenance dose of 10 g peanuts/day while
continuing treatment with omalizumab. If the CD-sens is still negative the withdrawal of
omalizumab will start by halving the dose in several steps.
The study is independent of pharmaceutical companies. Omalizumab is dosed according to body
mass and the amount of total IgE antibodies and therefore every individual has an individual
study duration. In average the duration of the study is estimated to 52 weeks +/-40/20 weeks.
Inclusion in the study is expected to last for the 2 coming years.
A treatment without serious side effects for those with severe food allergies would give a
great benefit with reduced anxiety and fear, but also major health economic benefits in the
form of fewer hospitalizations, sick leave, and to a greater extent completed school and
education.
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