Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Sponsor
Carsten Bindslev-Jensen
Study ID
NCT04037176
Phase
PHASE4
Status
Completed

Conditions

  • Food Allergy

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Omalizumab — DRUG
    Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE
  • Placebo — OTHER
    Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE

Study Details

Food allergy is a common disease in childhood affecting up to 8% of children in Westernized countries. About 30 percent of children with food allergies are allergic to more than one food, most often milk, egg, wheat, peanut and tree nut. Peanut and hazelnut are common triggers of severe and potentially fatal food-induced anaphylactic reactions. Currently, there is no curative treatment for food allergy. Novel therapies for this potentially life-threatening condition are therefore much needed.

Key Dates

Start date
Nov 1, 2019
Status verified
Dec 2023
Primary completion
Mar 15, 2022
Completion
Mar 15, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Omalizumab
    Omalizumab is a sterile solution in a prefilled syring for subcutaneous injection. The syrings contains 75 mg or 150 mg omalizumab. 75 patients will have Omalizumab in doses depending of body weight and IgE every 2. or 4. week for 6 month Omalizumab is administered subcutaneously
  • Placebo Comparator: Placebo
    Placebo contains sodium chloride 0,9 % in a prefilled syring for subcutaneous injection. 25 patients will have placebo depending of the body weight and IgE every 2. or 4. week in 3 month. They will subsequently get Omalizumab for 3 month if nonresponders. Placebo is administered subcutaneously

Primary Outcome Measure

Change in challenge threshold (mg food protein tolerated by oral intake) [ Time Frame: 0-3 months ]

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