Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy (FASTX)

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. Identifier: NCT02402231
Recruitment Status : Active, not recruiting
First Posted : March 30, 2015
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
Caroline Nilsson, Karolinska Institutet

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: Omalizumab Phase 2

Detailed Description:

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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: Omalizumab
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.
Drug: Omalizumab
Omalizumab is the treatment during oral immunotherapy with peanuts as protection

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • IgE to peanut, Ara h 1, Ara h 2 and Ara h 3
  • IgE to an airborne allergen i.e. cat, dog, horse, birch, grass etc.
  • Clinical allergic reactions to peanut the last 5 years
  • Positive conjunctival challenge to the selected airborne allergen
  • Positive CD-sens to peanut and the selected airborne allergen
  • IgE according to the recommendations of the manufacturer
  • Written consent

Exclusion Criteria:

  • No severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases
  • Pregnancy
  • No previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab

Information from the National Library of Medicine

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 identifier (NCT number): NCT02402231

Sachs´ Children´s Hospital, Södersjukhuset
Stockholm, Sweden, 11883
Sponsors and Collaborators
Caroline Nilsson
Principal Investigator: Caroline Nilsson, MD, PhD Dept of Clinical Science and Education, Karolinska Institutet

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Caroline Nilsson, MD, PhD, Karolinska Institutet Identifier: NCT02402231     History of Changes
Other Study ID Numbers: FASTXP2013
2012-005625-78 ( EudraCT Number )
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents