Protection From Food Induced Anaphylaxis by Reducing the Serum Level of Specific IgE (Protana).

• Status: Active, not recruiting
• Trial end date: 2023-03-03
• Target enrollment: 0
• Participant gender: All

Summary

Anaphylaxis elicited by accidental intake of the offending food constitutes a major health risk to the food allergic patient. Current advice for the food allergic patient is to avoid the offending food allergen and to carry an epinephrine autoinjector. However, novel treatments altering the clinical reactivity to the offending food thereby diminishing the risk of anaphylaxis are much needed. A correlation between the level of specific IgE in serum towards the offending food and the clinical sensitivity of the patient has been suggested. The clinical threshold for a food allergic reaction to occur is therefore hypothesized to increase by reducing the level of specific IgE to the relevant food allergen.

Therapy with Omalizumab has proven efficacious in lowering the level of IgE in serum but a high pre-treatment level of total IgE in serum potentially hampers the efficacy in a number of patients, as seen especially in patients with concomitant atopic dermatitis. The aim of this study is to investigate if the combination of initial IgE specific immunoadsorption combined with subsequent treatment with Omalizumab will increase the clinical threshold to the culprit food and thus prevent medical emergencies (anaphylaxis) in patients with severe food allergy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carsten Bindslev-Jensen
• Collaborators: Miltenyi Biomedicine GmbH; Miltenyi Biotec GmbH
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• Individuals aged 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included.

Exclusion Criteria:

• Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient's safety or study outcomes.

• Infection on the day of study

• Pregnancy or nursing. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception (birth control pill, implant, transdermal patch, vaginal ring or depot injection)). 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. It is accepted, if the female patient is permanently sterile or infertile, if her sole partner is permanently sterile or if they use both condom and diaphragm. The definition of sterile or infertile is surgically sterilized (vasectomy/bilateral salpingectomy, hysterectomy and/or bilateral ovariectomy) or post menopause defined as a non-menstrual period of at least 12 months before inclusion in the trial.

• Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests

• Ongoing treatment with β-blockers that cannot be paused one day prior to the tests

• Ongoing treatment with oral glucocorticoids (>10 mg daily)

• Alcohol abuse, abuse of opioids or other drugs

• Occurrence of unexpected side effects

• Patients who are not supposed to be able to meet the requirements in the protocol

• Patients who are physically or mentally unable to consent

• Patients who have reduced liver function or kidney function