AuthorisedTherapeutic exploratory (Phase II)Interventional

Omalizumab for monotherapy treatment of patients with food allergies to plant-based foods due to sensitization to LTP and profilin

This study is investigating a drug named omalizumab as a standalone treatment for people who have allergies to plant-based foods, such as peaches and melons. These allergies are linked to specific proteins called LTP and profilin. It's for patients whose allergies haven't responded well to a previous treatment involving peach protein. Researchers will give omalizumab to see if it helps these individuals become less sensitive to peaches and melons, allowing them to eat more of these foods without a reaction. They will also check if the treatment improves their quality of life. This is a phase 2 study, meaning it's still in the earlier stages of testing how well the medicine works and if it's safe.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

Enrolment target

Start

17 Apr 2026

What is this study about?

Imagine you have a food allergy that makes eating certain fruits, like peaches or melons, very difficult or even dangerous. This study is for people who have these types of allergies, specifically those linked to certain proteins called LTP (like the one found in peaches) and profilin (found in foods like melon). Sometimes, other treatments, such as trying to slowly get your body used to tiny amounts of the food, don't work for everyone. This study wants to find out if a medicine called omalizumab can make a difference.

Omalizumab is a medicine that's already used for other conditions, like severe asthma. In this study, doctors are giving it to people with these specific food allergies to see if it can calm down their immune system's overreaction. The main goal is to see if, after taking the medicine for a while, people can eat more of the foods they are allergic to (like peaches and melons) without having a bad reaction. This means they might be able to tolerate a larger amount of these foods safely.

Beyond just seeing if people can eat more, the study will also look at whether this treatment helps with other related food allergies and if it improves people's overall quality of life. For example, if you're allergic to peach LTP, you might also react to other similar fruits. The study hopes to show that this medicine could be a new way to help people manage their plant-based food allergies and live more freely, without constant worry about accidental exposure.

Key takeaways

This study is testing a medicine called omalizumab for plant-based food allergies.
It's for adults whose allergies to fruits like peach or melon are caused by specific proteins (LTP and profilin).
They are looking for people who haven't had success with another peach allergy treatment.
The main goal is to see if patients can safely eat more of the foods they are allergic to.
It's a Phase 2 study, meaning it's an earlier stage of testing the medicine's effectiveness and safety.
The study also aims to understand how omalizumab affects overall quality of life.

Who may be eligible?

To be considered for this study, individuals must be adults, aged 18 years or older.

This study is specifically designed for people who have allergies to certain plant-based foods, particularly those caused by a sensitivity to proteins called LTP and profilin. Importantly, it's for those whose allergy symptoms have not improved after trying another treatment specifically for peach allergy, called sublingual immunotherapy with Pru p 3.

Both men and women are welcome to participate, as long as they meet the age and specific allergy criteria.

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 18 years old or older?
Do you have allergies to plant-based foods, like peaches or melons?
Have you been told your allergy is due to certain proteins called LTP or profilin?
Have you previously tried a peach allergy treatment (Pru p 3 sublingual immunotherapy) without good results?
Are you generally able to commit to regular clinic visits for about 16 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a medicine called Omlyclo (omalizumab) as an injection, using a pre-filled syringe. The study will look at how your allergy symptoms change over 16 weeks of treatment. Before and after this period, doctors will assess how much peach (if you're allergic to LTP) or melon (if you're allergic to profilin) you can eat without a reaction. They will also check for changes in your allergy to other similar foods and how your quality of life is affected. You will have regular visits to the clinic for assessments and to receive your medication. The total duration of your active participation will be at least 16 weeks.

Potential risks and benefits

Taking part in a study like this might offer a potential benefit by helping you become less sensitive to certain foods, potentially improving your quality of life. However, like all medicines, omalizumab can have side effects, and some people might not respond to the treatment. There's always a risk that the treatment might not work or could cause unexpected reactions. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is omalizumab?

It's a medication that calms down the immune system, currently used for conditions like asthma, and being tested here for food allergies.

What are LTP and profilin?

They are types of proteins found in many plant-based foods that can cause allergic reactions in some people.

What does a 'monotherapy' mean?

It means the study is testing omalizumab as the only treatment for the allergy, not in combination with other new medicines.

Will I have to eat foods I'm allergic to?

Yes, carefully controlled amounts of foods like peach or melon will be given to see if your tolerance has improved after treatment.

Is this medicine available now for food allergies?

No, this is a research study (Phase 2), so omalizumab is not yet approved or available for treating these specific food allergies.