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

August 23, 2018 updated by: Caroline Nilsson

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11883
        • Sachs´ Children´s Hospital, Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 22 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caroline Nilsson

Investigators

  • Principal Investigator: Caroline Nilsson, MD, PhD, Dept of Clinical Science and Education, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 1, 2020

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

March 24, 2015

First Posted (ESTIMATE)

March 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASTXP2013
  • 2012-005625-78 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peanut Allergy

Clinical Trials on Omalizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe