Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A prospective, randomized, double-blind placebo-controlled multicentre trial with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescents and adults with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.

This research is testing a new injection designed to help people with birch pollen allergies, which cause symptoms like hay fever and itchy, watery eyes. It's a large-scale study that involves many people in different places. Participants will either receive the new treatment or a harmless dummy injection (called a placebo) without knowing which one they have. Researchers will then compare how well both groups manage their symptoms during the birch pollen season in 2025. The main goal is to find out if this new medicine can significantly reduce allergy symptoms and the need for other allergy medications. This type of study ensures results are fair and reliable.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Inmunotek S.L.

Enrolment target

360

Start

17 Oct 2024

birch pollen-induced allergic rhinitis birch pollen-induced allergic rhinoconjunctivitis

What is this study about?

This study is investigating a new way to treat birch pollen allergies, which make many people suffer from hay fever (allergic rhinitis) and itchy, watery eyes (allergic rhinoconjunctivitis). We're testing a special medicine that's given as an injection. It’s a bit like a vaccine, designed to help your body get used to the birch pollen so you react less strongly to it.

To make sure the results are fair and accurate, this is a 'double-blind' study. This means neither you nor your doctor will know if you're getting the active new medicine or a 'placebo' (a dummy injection that looks exactly the same but contains no medicine). This helps us avoid any bias and truly understand if the new medicine works better than doing nothing special for the allergy itself.

The main goal is to see how well the new treatment helps people manage their allergy symptoms during the birch pollen season in 2025. Researchers will track how much your symptoms bother you and how much other allergy medicine you need to take. If the active treatment group shows a significant reduction in symptoms compared to the placebo group, it suggests the new medicine could be a valuable option for people with birch pollen allergies.

Key takeaways

This study is testing a new injection for birch pollen allergy.
It's a 'double-blind' study, so no one knows who gets the real medicine.
The main aim is to reduce hay fever and itchy eye symptoms.
Participation involves injections and tracking symptoms.
You must be an adult with a birch pollen allergy to take part.
Your involvement helps improve future allergy treatments.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. The study welcomes everyone, regardless of whether you are male or female.

Crucially, you must have an allergy to birch pollen that causes symptoms like hay fever (sneezing, runny or blocked nose) or itchy, watery eyes. This is the specific condition the study is trying to treat.

Further checks will be made by the study team to ensure you meet all the specific requirements for participating, as only certain people can safely take part in medical research.

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 suffer from hay fever or itchy eyes because of birch pollen?
Are you able to attend clinic appointments regularly?
Are you willing to keep a diary of your symptoms?
Are you happy to receive injections as part of the treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive either the new allergy injection or a dummy injection. You won't know which one you're getting, and neither will your local study doctor. You'll have regular appointments at the clinic for assessments and to receive your injections. Throughout the study, especially during the birch pollen season in 2025, you'll be asked to keep track of your allergy symptoms and any other allergy medicines you take using a diary or app. The total duration of your involvement will be clearly explained by the study team, including how long the treatment period lasts and any follow-up visits.

Potential risks and benefits

Potential benefits of joining could include your birch pollen allergy symptoms improving, or helping researchers find new and better treatments for others in the future. However, there are also potential risks, such as side effects from the injection or treatment. These will be fully explained before you agree to take part. Remember, you can choose to leave 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
Germany

Common questions

What is a 'double-blind' study?

It means neither you nor your doctor will know if you're getting the new medicine or a dummy treatment, to keep the results fair.

What is a 'placebo'?

It's a dummy treatment that looks exactly like the real medicine but contains no active ingredients.

What kind of allergy does this study focus on?

This study is specifically for people who suffer from birch pollen allergies, causing hay fever or itchy eyes.

Will I have to stop taking my usual allergy medicines?

The study team will discuss all your current medications with you and advise if any changes are needed.

When will I know if the treatment worked?

The researchers will compare symptoms in 2025 during the pollen season, but individual results will not be shared until the study is complete and analysed.