NCT02402231

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2013

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

7 years

First QC Date

November 28, 2013

Last Update Submit

August 23, 2018

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (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.

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

Study Arms (1)

Omalizumab

EXPERIMENTAL

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

Interventions

OmalizumabDRUG

Omalizumab is the treatment during oral immunotherapy with peanuts as protection

Omalizumab

Eligibility Criteria

Age12 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sachs´ Children´s Hospital, Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 34669990DERIVED

  • 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.

    PMID: 31329313DERIVED

  • 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.

    PMID: 27883239DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-IdiotypicAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalSerum GlobulinsGlobulins

Study Officials

  • Caroline Nilsson, MD, PhD

    Dept of Clinical Science and Education, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 28, 2013

First Posted

March 30, 2015

Study Start

October 1, 2013

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

SE(1)