AuthorisedPhase II and Phase III (Integrated)Interventional

Phase II-III study to assess the efficacy and safety of sublingual immunotherapy in patients suffering from birch pollen allergy

This study aims to discover if a new medicine, taken under the tongue, can effectively and safely treat birch pollen allergy. Many people suffer from moderate to severe symptoms like a runny nose, sneezing, and itchy eyes when birch pollen is in the air. Researchers are comparing different doses of this new medicine to a dummy treatment (placebo). They want to see if the medicine can reduce allergy symptoms and the need for other allergy medications. The study will also look at how well people feel and their quality of life during birch pollen season. This is an important step in finding new and improved treatments for pollen allergies.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

ROXALL Medizin GmbH

Enrolment target

Start

27 May 2025

What is this study about?

If you've ever had a runny nose, sneezing fits, or itchy, watery eyes when birch trees are in bloom, you know how disruptive birch pollen allergy can be. This study is designed to help us find a more effective way to manage these annoying and sometimes severe symptoms. Researchers are particularly interested in a new type of treatment called sublingual immunotherapy, which involves taking medicine under your tongue.

At its heart, this study wants to see if this new under-the-tongue medicine can make a real difference for people with moderate to severe birch pollen allergy. They're testing different strengths of the medicine to find out which dose works best to reduce your allergy symptoms. They'll also be closely watching to see if the medicine is safe and doesn't cause too many side effects.

By carefully comparing people who take the new medicine with those who take a dummy treatment (a placebo), the researchers hope to understand if this new approach can significantly improve the lives of those affected by birch pollen. The results could lead to a better treatment option that helps you feel much better during allergy season.

Key takeaways

Tests an under-the-tongue medicine for birch pollen allergy.
Compares different doses against a dummy treatment (placebo).
Aims to reduce allergy symptoms and medication use.
Focuses on people with moderate to severe birch pollen allergy.
Results could lead to improved allergy treatments.

Who may be eligible?

To be part of this study, you generally need to be an adult, aged 18 years or older.

Crucially, you must have birch pollen allergy that causes moderate to severe symptoms. This means you’ve experienced a runny nose, sneezing, or itchy eyes due to birch pollen for at least the past two years. Your doctor will use specific guidelines to determine if your allergy fits this description.

Both men and women can participate in this research. Before joining, the study team will ask you some questions and do some checks to make sure the study is a good fit for you and safe for your health.

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 get moderate-to-severe allergy symptoms from birch pollen?
Have you had these birch pollen allergy symptoms for at least two years?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

This study will involve taking a medicine, or a dummy treatment (placebo), under your tongue at home. You'll be assigned to one of four groups: a placebo group, or one of three groups receiving different doses (low, medium, or high) of the active medicine. The appearance, smell, and taste of all treatments will be the same, so you won't know which one you're taking.

Throughout the study, you'll be asked to keep a record of your allergy symptoms and any other allergy medicines you take. You'll have regular visits to the clinic so the study team can monitor your progress and check for any side effects. They'll also perform various assessments, which might include specific allergy tests over time. The total duration of your participation will involve an initial assessment period, the treatment phase, and a follow-up period to see how you are doing after treatment concludes.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could reduce your birch pollen allergy symptoms and improve your quality of life, potentially better than current options. However, there's always a chance the treatment might not work for you, or you might experience side effects, which the study team will monitor closely. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your 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 'sublingual immunotherapy'?

It's a treatment where you place a small amount of medicine under your tongue to help your body get used to the allergen, like birch pollen, and reduce your allergic reactions.

What is a 'placebo'?

A placebo is a dummy treatment that looks and feels exactly like the active medicine but contains no active ingredients. It helps researchers compare the real medicine's effects.

Who can join this study?

Adults aged 18 and over, who have had moderate to severe birch pollen allergy symptoms for at least two years, can potentially join.

Will I know if I'm getting the real medicine?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving the active medicine or the placebo. This helps ensure fair and accurate results.

What kind of symptoms are they tracking?

Researchers will be tracking symptoms like sneezing, runny nose, blocked nose, itchy nose, itchy eyes, and watery eyes, as well as how much other allergy medicine you need.