Behandling af Boern Med Foedevareallergi Med Omalizumab (Xolair)

  • STATUS
    Recruiting
  • End date
    Feb 1, 2022
  • participants needed
    100
  • sponsor
    Carsten Bindslev-Jensen
Updated on 25 January 2021
allergen
omalizumab
anaphylaxis
xolair

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.

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

Details
Condition Food Allergy, food allergies
Treatment Placebo, omalizumab
Clinical Study IdentifierNCT04037176
SponsorCarsten Bindslev-Jensen
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 6 yrs and 18 yrs?
Gender: Male or Female
Do you have Food Allergy?
Do you have any of these conditions: Food Allergy or food allergies?
children between 6 and 18 years
a clinical diagnosis of food allergy to 1 food allergen
a positive SPT (mean wheal diameter > 3 mm)
s-IgE > 0.35 kIU/l
a positive food challenge with a threshold at or below 300 mg of protein (443 mg cumulative) in a double blind placebo controlled food challenge (DBPCFC)
(If the patient is allergic to more than one food allergen, the allergen with the highest probability of fulfilling the inclusion criteria (based on case history, level of s-IgE and when available challenge results within the last year) will be used)

Exclusion Criteria

t-IgE >1500 kIU/L
Significant co-morbidity that might compromise the patient's safety or study outcomes
Pregnancy or nursing in the adolescents. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception if sexual active). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken
Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused during the study
Ongoing treatment with drugs that may impair safety during food challenge e.g. -blockers or ACE-inhibitors that cannot be paused during the study
Ongoing treatment with oral glucocorticoids/Omalizumab/allergen immunotherapy (AIT)
Alcohol abuse, abuse of opioids or other drugs in adolescents
Treated with Omalizumab until years before the study
Patients/parents who are not supposed to be able to meet the requirements in the protocol
Patients/parents who are physically or mentally unable to consent
Patients who have reduced liver function or kidney function
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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