NCT04037176

Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Treatment With Omalizumab in Food Allergic Children (TOFAC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Carsten Bindslev-Jensen · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Food Allergy

Interventions

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

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2019-07-30
• Last updated: 2023-12-05

Locations

1 site across 1 country: Denmark