Active not recruitingPHASE2INTERVENTIONAL

Omalizumab to Accelerate a Symptom-driven Multi-food OIT

This study is testing a medicine called omalizumab to see if it can help speed up a treatment for people with multiple severe food allergies. This treatment, called oral immunotherapy (OIT), involves gradually eating tiny amounts of problem foods to help the body get used to them. Researchers want to find out if omalizumab, given before and during OIT, can make the process faster and easier. They are comparing two different doses of omalizumab against a dummy treatment (placebo) in young people aged 6 to 25. The main goal is to see if omalizumab helps patients reach a protective dose of their allergic foods more quickly.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Philippe Bégin

Enrolment target

Start

11 Nov 2019

Estimated completion

01 Mar 2026

Food IgE-mediated Allergy Immunotherapy Omalizumab Physiological Effects of Drugs

What is this study about?

Imagine you have severe allergies to several common foods. Many people with food allergies live in fear of accidentally eating something that could cause a serious reaction. A treatment called oral immunotherapy (OIT) can help. It involves carefully eating tiny, increasing amounts of the foods you're allergic to, over a long time, to reduce your body's reaction. However, this process can be slow and sometimes tricky.

This study is looking at whether a medication called omalizumab, which is already used for other allergic conditions like severe asthma, could make OIT for multiple food allergies safer and faster. The idea is that omalizumab might calm down the body's over-the-top allergic reactions, making it easier to gradually increase the amount of food eaten without as many side effects. This could help people reach a stage where they can eat small amounts of their allergic foods without a severe reaction much more quickly.

The researchers are testing two different doses of omalizumab to see which one works best, compared to a placebo (a treatment that looks like the drug but contains no active medicine). If successful, this could mean a quicker path to better protection for many people living with multiple severe food allergies, improving their quality of life and reducing anxiety around food.

Key takeaways

This study is for people aged 6-25 with multiple serious food allergies.
It tests if omalizumab can speed up food desensitisation (OIT).
Two different doses of omalizumab are being compared to a dummy treatment (placebo).
Participation involves regular clinic visits and careful eating of allergic foods.
The goal is to help people reach a protective food dose more quickly and safely.
Strict safety measures are in place to manage potential allergic reactions.

Who may be eligible?

This study is looking for volunteers between the ages of 6 and 25 years old. To be considered, you must have a confirmed IgE-mediated allergy to at least three different foods from a specific list (like peanut, milk, egg, wheat, and various nuts). You must also be strictly avoiding these foods in your daily life. Doctors will perform tests, including a skin prick test and a special food challenge, to confirm your allergies and ensure you react to a certain amount of the food.

There are also reasons why someone might not be able to join the study. For example, if you have very severe asthma, a condition called eosinophilic oesophagitis, or are currently having other allergy treatments, you won't be eligible. The study also can't include pregnant or breastfeeding individuals, or anyone taking certain medications like beta-blockers. Importantly, you and your parents (if you're under 18) must be comfortable with the study's requirements and willing to eat a small, daily dose of the allergic foods.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 6 and 25 years old?
Do you have confirmed allergies to at least three specific foods (like peanut, milk, egg, certain nuts)?
Are you currently avoiding these foods completely?
Do you have asthma that is not severe, and no other serious medical conditions like eosinophilic oesophagitis?
Are you able to stop antihistamines before study tests if needed?
Are you willing to eat a small, daily dose of your allergic foods as part of the treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey would involve several steps over about 20 weeks. First, there's a screening period where doctors confirm your allergies with special tests, including a 'food challenge' in a safe medical setting. If you're eligible, you'll be assigned by chance to either one of the two omalizumab doses or a placebo (which looks the same but contains no active medicine).

You'll receive your assigned study medicine for 8 weeks before starting the food treatment. After this, you'll begin a process called Oral Immunotherapy (OIT). This means you'll eat tiny amounts of your allergic foods (three at a time) that will gradually increase. You'll attend clinic visits every two weeks for supervised 'up-dosing,' where the amount of food you eat is slowly increased until you reach a specific target dose (1500mg of protein, or 500mg per food). Throughout the study, there will be regular checks to monitor your health and how you react to the treatments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that omalizumab might help you reach a protective dose of your allergic foods more quickly and with fewer reactions during the OIT process. This could improve your quality of life. However, like all medicines, omalizumab can have side effects, and OIT itself carries a risk of allergic reactions, which could be severe in some cases. The study team will closely monitor you and have medical staff ready to help if any reactions occur. You also have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

The Hospital for Sick Children
Verified postcode
Toronto, Canada
Centre Hospitalier Universitaire Sainte-Justine
Verified postcode
Montreal, Canada
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Verified postcode
Sherbrooke, Canada

Common questions

What is oral immunotherapy (OIT)?

OIT is a treatment where you gradually eat tiny, increasing amounts of a food you're allergic to, hoping your body will learn to tolerate it and react less severely.

What is omalizumab?

Omalizumab is a medicine that blocks a part of the immune system involved in allergic reactions. It's often used for conditions like severe asthma.

Will I know if I'm getting the real drug or a placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you're receiving omalizumab or the placebo until the study is over. This helps ensure fair results.

What foods are included in this study?

The study focuses on common allergens like peanut, milk, egg, wheat, oat, soy, barley, rye, buckwheat, hazelnut, pecan, cashew, pistachio, almond, walnut, and sesame. You must be allergic to at least three of these.

How long will I be in the study?

The main treatment period for the study drug and OIT will last about 20 weeks, including an 8-week pre-treatment period.