Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled study to study the effect of Omalizumab on
      children with food allergy.

      Primary endpoint: Change in challenge threshold after 3 months of treatment in patients
      treated with Omalizumab versus placebo.

      Secondary endpoints: Change in challenge threshold at 6 months. Change in Skin Prick Test
      (SPT), serum markers for allergy (specific IgE, IgG4, BAT (basofil activation test)),
      severity of comorbidity, and quality of life from at 3 and 6 months. Change in treshold
      within and between the groups.

      The investigator's hypothesis is that increased Omalizumab dose and/or a longer treatment
      period will increase food allergy threshold.

      Within the groups:

        -  3 months treatment with Omalizumab in asthma dose versus 6 months with Omalizumab in
           asthma dose - in primary responders

        -  3 months treatment with Omalizumab in asthma dosing versus 3 months additional treatment
           with Omalizumab in max dose - in primary non-responders

        -  3 months treatment with placebo versus 6 months with placebo- in primary
           placebo-responders

        -  3 months treatment with placebo versus 3 months with max dose Omalizumab - placebo cross
           over to active.

      Between the groups:

        -  3 months treatment with Omalizumab in asthma dose versus 3 months with max dose
           Omalizumab

        -  6 months treatment with Omalizumab in asthma dose versus 3 months with max dose
           Omalizumab.

      Patients are randomized electronically via an e-CRF prepared by OPEN in RedCap. Assigned 3:1
      to Omalizumab or placebo in 13 x 8 block (6:2) by a blinded health care person.

      GCP-monitoring is performed by the local GCP-unit at Odense University Hospital
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE; Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE
Other intervention name(s): Xolair; NaCl
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible participants will be randomized to treatment with Omalizumab (regular dose of asthma dosing according to total IgE and weight) or placebo (3:1). Primary endpoint after 3 months treatment.
Responders (in the active as well as the placebo group) will continue treatment with the same dose of Omalizumab/placebo for a further 3 months. All non-responders will receive maximum dose of Omalizumab (according to weight, but not total IgE) for another 3 months.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Omalizumab; Xolair