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

Primary Purpose

Peanut Allergy

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
Caroline Nilsson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peanut Allergy

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sachs´ Children´s Hospital, Södersjukhuset

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omalizumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2013
Last Updated
August 23, 2018
Sponsor
Caroline Nilsson
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1. Study Identification

Unique Protocol Identification Number
NCT02402231
Brief Title
Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy
Acronym
FASTX
Official Title
Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Caroline Nilsson

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Intervention Description
Omalizumab is the treatment during oral immunotherapy with peanuts as protection
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Nilsson, MD, PhD
Organizational Affiliation
Dept of Clinical Science and Education, Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sachs´ Children´s Hospital, Södersjukhuset
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34669990
Citation
Bjorkander S, Merid SK, Brodin D, Brandstrom J, Fagerstrom-Billai F, van der Heiden M, Konradsen JR, Kabesch M, van Drunen CM, Golebski K, Maitland-van der Zee AH, Potocnik U, Vijverberg SJH, Nopp A, Nilsson C, Melen E. Transcriptome changes during peanut oral immunotherapy and omalizumab treatment. Pediatr Allergy Immunol. 2022 Jan;33(1):e13682. doi: 10.1111/pai.13682. Epub 2021 Oct 31. No abstract available.
Results Reference
derived
PubMed Identifier
31329313
Citation
Brandstrom J, Vetander M, Sundqvist AC, Lilja G, Johansson SGO, Melen E, Sverremark-Ekstrom E, Nopp A, Nilsson C. Individually dosed omalizumab facilitates peanut oral immunotherapy in peanut allergic adolescents. Clin Exp Allergy. 2019 Oct;49(10):1328-1341. doi: 10.1111/cea.13469. Epub 2019 Aug 15.
Results Reference
derived
PubMed Identifier
27883239
Citation
Brandstrom J, Vetander M, Lilja G, Johansson SG, Sundqvist AC, Kalm F, Nilsson C, Nopp A. Individually dosed omalizumab: an effective treatment for severe peanut allergy. Clin Exp Allergy. 2017 Apr;47(4):540-550. doi: 10.1111/cea.12862. Epub 2017 Jan 10.
Results Reference
derived

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

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