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Study on the Safety and Effectiveness of Betula Pollen Extract for Children and Adolescents Aged 5-17 with Birch Pollen Allergies and Possible Asthma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as birch pollen-induced allergic rhinoconjunctivitis, which is an allergic reaction that affects the nose and eyes, often causing symptoms like sneezing, itching, and watery eyes. The study is also considering participants who have this condition along with asthma. The treatment being tested is called STALORAL® Birch 300 IR, which is an oromucosal solution, meaning it is a liquid that is applied inside the mouth. This treatment contains an extract from birch pollen, which is intended to help the body build a tolerance to the allergen and reduce symptoms over time.

The purpose of the study is to evaluate the safety and effectiveness of STALORAL® Birch 300 IR in children and adolescents aged 5 to 17 years. Participants in the study will be randomly assigned to receive either the STALORAL® Birch 300 IR treatment or a placebo, which is a substance with no active medication. Neither the participants nor the doctors will know which treatment is being given to ensure unbiased results. The study will last for a period of up to 13 months, during which participants will regularly use the treatment and report their symptoms and any changes they experience.

Throughout the study, participants will be monitored to assess how well the treatment works in reducing symptoms of allergic rhinoconjunctivitis and the need for additional medication. The trial aims to provide valuable information on whether STALORAL® Birch 300 IR can be a safe and effective option for managing symptoms in young people with birch pollen allergies, potentially improving their quality of life during the pollen season.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the STALORAL Birch 300 IR or a placebo. Neither the patient nor the doctor will know which treatment is being administered.

  2. Step 2

    Treatment administration

    The treatment involves the use of an oromucosal solution, which is a liquid placed under the tongue. This method is known as sublingual use.

    The active substance in the treatment is betula pollen extract.

  3. Step 3

    Treatment schedule

    The patient will receive the treatment daily. The dosage and specific instructions will be provided by the healthcare team overseeing the trial.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient will be required to complete an e-Diary using a mobile application. This will involve daily entries to track symptoms and any use of additional medication.

    Regular assessments will be conducted to monitor the patient's response to the treatment and any side effects.

  5. Step 5

    End of trial

    The trial is expected to conclude by July 31, 2025. At the end of the trial, the patient's overall response to the treatment will be evaluated.

Who can join the trial?

9 criteria

  • Must be able to sign and date the informed consent form before any trial-specific procedure. If unable to sign, a box can be checked on the form. Parents or legal representatives must give written consent for minors.
  • Must have health insurance as required by local regulations.
  • Must be between the ages of 5 and 17 at the time of the randomization visit.
  • Must have a documented history of moderate to severe **Allergic Rhinoconjunctivitis (ARC)** caused by birch pollen, diagnosed by a doctor. This means having symptoms like a runny nose and itchy eyes during at least one previous birch pollen season for ages 4 to 6, or at least two seasons for ages 7 to 17, even after using symptom-relieving medication.
  • Must have a **Total Symptom Score (TSS)** of at least 12 out of 18 from the previous birch pollen season and a score of at least 30 on a **Visual Analog Scale (VAS)**, which measures the severity of symptoms. This can be evaluated by the patient or a parent/legal representative if the patient cannot do it themselves.
  • Must have a positive **Skin Prick Test (SPT)** to birch pollen at the screening visit. This test is positive if it causes a skin reaction with a wheal (bump) of at least 3.0 mm in diameter.
  • Must have a positive test for specific **Immunoglobulin E (IgE)**, which are antibodies, to birch pollen allergens at screening. The level must be at least 0.7 kU/L.
  • All female patients who can become pregnant must have a negative urine pregnancy test before randomization.
  • Must have internet access at home or on a portable device to complete an electronic diary daily using a mobile phone app. This starts 4 months before the pollen season.

Who cannot join the trial?

9 criteria

  • Individuals who do not have **birch pollen-induced allergic rhinoconjunctivitis**. This is a condition where the nose and eyes become irritated due to an allergy to birch pollen.
  • Individuals who are not within the specified age range for the study. The study is focused on children and adolescents.
  • Individuals who are not willing or able to follow the study procedures and requirements.
  • Individuals who have other medical conditions that might interfere with the study or its results.
  • Individuals who are currently participating in another clinical trial.
  • Individuals who have a history of severe allergic reactions that could pose a risk during the study.
  • Individuals who are pregnant or breastfeeding, as the study may not be safe for them.
  • Individuals who have used certain medications that could affect the study results.
  • Individuals who have a known allergy to any component of the study medication.
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Investigated drugs

STALORAL® Birch 300 IR is a medication used in this clinical trial to treat children and adolescents aged 5 to 17 years who suffer from allergic reactions caused by birch pollen. This medication aims to reduce symptoms such as runny nose, itchy eyes, and sneezing, which are common in allergic rhinoconjunctivitis. It may also help in reducing the need for other medications that relieve allergy symptoms. The trial is designed to assess the safety and effectiveness of this treatment in managing these allergy symptoms, with or without the presence of asthma.

What is already known about the treatment

STALORAL® Birch 300 IR – This medication is administered as a sublingual tablet, meaning it is placed under the tongue to dissolve. It is currently being studied in a Phase IIIb clinical trial to assess its safety and effectiveness in treating children and adolescents aged 5 to 17 years with allergic rhinoconjunctivitis caused by birch pollen, with or without asthma. The main therapeutic indication is to alleviate symptoms of allergic rhinoconjunctivitis, which includes nasal congestion, runny nose, and itchy eyes. At the molecular level, it works by gradually desensitizing the immune system to birch pollen allergens, reducing the severity of allergic reactions. It is classified as an allergen immunotherapy, which aims to modify the immune response to specific allergens.

Investigated diseases

Birch Pollen-induced Allergic Rhinoconjunctivitis – This condition is an allergic reaction that occurs when the immune system overreacts to birch pollen. It primarily affects the eyes and nose, leading to symptoms such as sneezing, runny or blocked nose, itchy and watery eyes, and sometimes itching in the throat or ears. The symptoms typically appear during the birch pollen season, which can vary depending on the geographical location. The condition is more common in children and adolescents, and symptoms can interfere with daily activities and sleep. Over time, repeated exposure to birch pollen can lead to a worsening of symptoms if not managed properly.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-509833-38-00Protocol codeYOBI/SL79.22Estimated enrolment699 patientsSponsorStallergenes

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