AuthorisedTherapeutic exploratory (Phase II)Interventional

Sublingual Birch Immunotherapy for Pollen-associated Food Allergy

This study is investigating a new treatment for people who suffer from food allergies linked to pollen, specifically those who react to foods like apples because they are also allergic to birch pollen. Researchers are testing a small tablet, called ITULAZAX, that you place under your tongue. The main goal is to see if this tablet can reduce symptoms like itching or stinging in your mouth after eating an apple. They will compare how people feel before and after taking the treatment. They are also looking at overall quality of life, asthma symptoms, and any side effects. This is a Phase II study, meaning it’s an early stage of testing to see if the treatment works and is safe, before larger studies are done.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Enrolment target

Start

29 May 2026

Pollen-associated Food Allergy Birch pollen Allergy

What is this study about?

If you've ever felt tingly, itchy, or swollen after eating certain fruits like apples, especially if you also have hay fever from birch pollen, you might have what's called pollen-associated food allergy. This happens when your immune system gets confused. It recognises similarities between proteins in birch pollen and proteins in some foods, causing an allergic reaction. This study is exploring a new way to help your body cope with these reactions.

The main treatment being tested is called ITULAZAX. It's a small tablet designed to be placed under your tongue. This type of treatment, where you put something under your tongue, is a way to try and retrain your immune system so it reacts less strongly to the things that trigger your allergy. The aim is to see if this tablet can make your reactions to foods like apples less severe or less frequent.

Researchers will carefully measure how your symptoms change, particularly the itching or stinging you might feel in your mouth after eating an apple. They'll also be checking on your general well-being, any asthma symptoms you might have, and making sure the treatment is safe. This is an exploratory Phase II study, which means it's an important early step to find out if this treatment is effective and safe enough to be studied further.

Key takeaways

This study is testing a new under-the-tongue tablet for food allergies linked to pollen.
It's for adults who react to foods like apples due to birch pollen allergy.
The main goal is to see if the tablet reduces symptoms like mouth itching after eating an apple.
It's an early-stage study to check if the treatment works and is safe.
You will have regular clinic visits and doctors will monitor your health closely.

Who may be eligible?

This study is looking for adults, aged 18 years and older. Both men and women can take part.

To be eligible, you need to have a special type of food allergy that is linked to pollen. Specifically, you should get allergic reactions when you eat certain foods, like apples, because you are also allergic to birch pollen.

There might be other specific health requirements or conditions that mean you can or cannot join, so the study team will ask you questions about your health and do some checks.

Quick self-check

Are you 18 years old or older?
Do you get allergic reactions to certain foods (like apples) because of a pollen allergy (like birch pollen)?
Are you able to attend regular clinic appointments?
Do you understand that you might receive a placebo (dummy treatment)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will be given one of two treatments: either the study medication (ITULAZAX) or a comparison treatment, which might be another common treatment for similar issues or a dummy treatment (placebo). You won't know which one you're receiving, but the study team will. You'll take this treatment regularly as instructed.

Throughout the study, you'll have several visits to the clinic. At these visits, doctors and nurses will check your health, ask how you're feeling, and perform some tests. This will include important assessments like eating a small amount of apple to see how you react, and then describing any symptoms like itching or stinging. They will also do physical check-ups and take blood samples. Your participation will involve keeping track of any symptoms and how you feel, and noting down any other medications you take. The study will last for a certain period, and you will have follow-up appointments even after you stop taking the study medication to make sure you're doing well.

Potential risks and benefits

Participating in a clinical study can offer potential benefits, such as access to new and potentially effective treatments not yet widely available. There's a chance the study treatment might help reduce your allergy symptoms. However, as with all treatments, there are potential risks. You might experience side effects from the medication, which could include local reactions in your mouth or more general allergic reactions. The study team will carefully monitor you for any such reactions. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Germany

Common questions

What is pollen-associated food allergy?

It's when you have allergic reactions to certain foods, like apples, because your body confuses their proteins with similar ones found in pollen, like birch pollen.

What is the treatment being tested?

It's a tablet called ITULAZAX, which you place under your tongue. It aims to help your immune system react less strongly to allergens.

Will I know if I'm getting the active treatment?

No, this is usually a 'blinded' study, meaning neither you nor the study team will know whether you're getting the active treatment or a comparison treatment.

What kind of reactions will they be looking for?

They will primarily be looking for symptoms like itching, stinging, or prickling in your mouth shortly after you eat an apple in a controlled setting.

How long will I need to be in the study?

The total duration of the study, including treatment and follow-up, will be explained by the study team, but it will involve several visits over time.