TerminatedPhase 4

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

Stopped: Finished

Denmark7 participantsStarted 2019-07-01

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in food challenge threshold (as measured in amount of food protein in milligrams tolerated by oral challenge)

Timeframe: 18 weeks

Trial details

NCT IDNCT03964051

SponsorCarsten Bindslev-Jensen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-21

View on ClinicalTrials.gov More Food Allergy trials