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

Sponsor
Caroline Nilsson
Study ID
NCT02402231
Phase
PHASE2
Status
Unknown

Conditions

  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
12 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    Omalizumab is the treatment during oral immunotherapy with peanuts as protection

Study Details

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).

Key Dates

Start date
Oct 31, 2013
Status verified
Aug 2018
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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 ]

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