AuthorisedTherapeutic confirmatory (Phase III)Interventional

Intralymphatic Allergen Immunotherapy (ILIT) in grass pollen allergy: a randomized controlled trial

If you suffer from grass pollen allergy, this study might be of interest. Researchers are testing a new treatment called Intralymphatic Allergen Immunotherapy (ILIT). This is a Phase 3 trial, meaning it's a crucial step to see how well the new treatment works compared to a 'dummy' solution (a saline solution, which is just salt water and has no active medication). The main goal is to find out if ILIT can reduce common hay fever symptoms like a runny or blocked nose, sneezing, and red, itchy, or watery eyes. They'll also check if people need to use less allergy medication and how their quality of life improves. It's for adults aged 18 and over, open to everyone regardless of sex.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

University Of Foggia

Enrolment target

Start

28 Oct 2025

allergic diseases (allergic rhinosinusitis allergic asthma allergy to Hymenoptera venoms)

What is this study about?

This study is investigating a new approach to help people who suffer from grass pollen allergy, often known as hay fever. Hay fever can cause a lot of uncomfortable symptoms like sneezing, a runny or blocked nose, and itchy, watery eyes, which can really affect your daily life.

The new treatment being tested is called Intralymphatic Allergen Immunotherapy (ILIT). This is a type of treatment that aims to get your body used to the allergen (in this case, grass pollen) so that your immune system doesn't overreact as much when you're exposed to it. The researchers want to see if this treatment is more effective than a simple saline solution, which acts as a comparison to ensure any improvements are truly due to the ILIT and not other factors.

This kind of study is called a 'Phase 3' trial. This means it's a large-scale study designed to confirm how well the treatment works and if it's safe to use for a broader patient population. The results of studies like this are very important for deciding if a new treatment can be made available more widely to people who need it.

Key takeaways

Tests a new treatment (ILIT) for grass pollen allergy.
Compares ILIT to a non-active saline solution.
Aims to reduce hay fever symptoms and medication use.
Involves adults aged 18 and over.
Results will help determine if ILIT could be a new option for allergy sufferers.
Participation includes symptom tracking and quality of life questionnaires.

Who may be eligible?

This study is looking for adult volunteers who experience grass pollen allergy.

To join, you must be 18 years old or older. The study is open to both men and women.

Specific details about your health history and other medications will be discussed to ensure the study is safe and appropriate for you.

Quick self-check

Are you 18 years old or older?
Do you suffer from grass pollen allergy (hay fever)?
Are you able to attend study visits regularly?
Are you open to potentially receiving either the new treatment or a comparison solution?

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, you would be assigned to either receive the new Intralymphatic Allergen Immunotherapy (ILIT) or a saline solution (a non-active comparison). You would not know which one you are receiving, nor would the doctors treating you – this helps ensure fair results.

Your participation would involve several visits to the study site. During these visits, the research team would assess your allergy symptoms, such as how runny or blocked your nose is, how much you sneeze, and if your eyes are red, itchy, or watery. You would be asked to keep track of your symptoms using a simple scoring system and also record any allergy medications you take, like antihistamine tablets, nasal sprays, or eye drops.

Additionally, you would complete questionnaires about how your allergy affects your quality of life. The total duration of your participation, including the treatment and follow-up assessments, would be clearly explained by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as a reduction in your grass pollen allergy symptoms and possibly needing less allergy medication. However, as with any medical study, there's no guarantee of personal benefit, and new treatments can have potential side effects or reactions. The research team will explain all known and potential risks in detail, and your safety will be carefully monitored throughout the study. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Italy

Common questions

What is Intralymphatic Allergen Immunotherapy (ILIT)?

It's a new type of treatment being tested for allergies, which aims to help your body become more tolerant to allergens like grass pollen.

What's the difference between this treatment and a 'dummy' solution?

The ILIT solution contains the active treatment, while the 'dummy' solution (saline) is just salt water and helps researchers compare the effects fairly.

Will I know if I'm getting the actual treatment or the 'dummy' solution?

Neither you nor the doctors will know which you are receiving; this is called 'blinding' and helps make the study results more reliable.

What kind of symptoms will the study be looking at?

They will assess common hay fever symptoms like runny nose, blocked nose, sneezing, and red, itchy, or watery eyes.

Why is this study important?

It's a key stage of research (Phase 3) that helps to confirm if this new treatment works and is safe before it might be considered for wider use.