Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04037176
Study type	Interventional
Source	Odense University Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	November 1, 2019
Completion date	March 15, 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.