Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy (FASTX)
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|ClinicalTrials.gov Identifier: NCT02402231|
Recruitment Status : Active, not recruiting
First Posted : March 30, 2015
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peanut Allergy||Drug: Omalizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Omalizumab is given to protect the study object from severe allergic reactions while they are going through oral immunotherapy with peanuts. There wïll be only one arm. The study objects are their own controls by also having allergy to airborne allergens. The dose is calculated by the study objects body mass and number of total IgE antibodies.
Omalizumab is the treatment during oral immunotherapy with peanuts as protection
- Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge. [ Time Frame: The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402231
|Sachs´ Children´s Hospital, Södersjukhuset|
|Stockholm, Sweden, 11883|
|Principal Investigator:||Caroline Nilsson, MD, PhD||Dept of Clinical Science and Education, Karolinska Institutet|