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Study on the Effects of Mannan-Conjugated Birch Pollen Allergoids for Adolescents and Adults with Birch Pollen-Induced Allergic Rhinitis or Rhinoconjunctivitis

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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 the effects of a new treatment for people with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. These conditions are commonly known as hay fever, where exposure to birch pollen causes symptoms like sneezing, runny nose, and itchy eyes. The treatment being tested is called T502, which is a special type of vaccine made from birch pollen. It is given as an injection under the skin.

The purpose of the study is to see how well the T502 treatment works in reducing allergy symptoms and the need for other allergy medications during the peak birch pollen season. Participants in the study will receive either the T502 treatment or a placebo, which looks like the treatment but does not contain the active ingredient. The study will compare the symptoms and medication use between those receiving the actual treatment and those receiving the placebo.

Participants will be involved in the study for a period that includes the peak birch pollen season. During this time, they will receive regular injections and will be monitored for any changes in their allergy symptoms. The study aims to provide valuable information on the effectiveness of T502 in managing symptoms of birch pollen allergies.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the clinical trial, participants will attend an initial visit. During this visit, eligibility will be confirmed based on specific criteria, including age, health status, and a history of birch pollen allergy.

    Participants will undergo a skin prick test to confirm sensitivity to birch pollen. This involves a small amount of allergen being placed on the skin, usually on the forearm, and lightly pricked to allow the allergen to enter the skin.

  2. Step 2

    Treatment phase

    Participants will receive the investigational treatment, which is a mannan-conjugated birch pollen allergoid, administered through a subcutaneous injection. This means the injection is given under the skin.

    The treatment will be given at regular intervals as determined by the study protocol. The exact frequency and duration will be explained during the initial visit.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, participants will be monitored for any changes in symptoms and any side effects. Regular follow-up visits will be scheduled to assess the impact of the treatment.

    Participants will be asked to keep a daily record of their symptoms and any medication they take for their allergy. This information will help in evaluating the effectiveness of the treatment.

  4. Step 4

    End of trial

    At the end of the trial, participants will have a final visit to assess their overall health and the impact of the treatment.

    The results of the trial will be analyzed to determine the effectiveness of the treatment in reducing symptoms of birch pollen-induced allergic rhinitis or rhinoconjunctivitis.

Who can join the trial?

12 criteria

  • Participants must be aged between 12 and 64 years. At least 10% of participants should be aged 12-17 years.
  • Participants must sign and date an Informed Consent Form. For adolescents, both the participant and their parents or legal guardians must sign and date the form.
  • Participants should be in good physical and mental health.
  • Participants must have a diagnosis of birch pollen allergy, which includes:
    • A history of moderate to severe allergic reactions to birch pollen for at least two previous seasons.
    • Use of anti-allergic medication for at least two birch pollen seasons before joining the study.
    • A positive skin prick test for birch pollen allergens, which involves a small reaction on the skin when exposed to the allergen.
    • Females of childbearing potential must agree to use a highly effective method of contraception, such as hormonal methods, an intrauterine device (IUD), or other reliable methods. Females who cannot have children do not need to meet this requirement.
    • Participants with asthma must have a confirmed diagnosis of controlled asthma according to specific guidelines.
    • For participants with asthma, their lung function must be at least 80% of the expected value, measured during the screening visit.
    • Laboratory tests must show:
      • A specific level of IgE antibodies against birch pollen allergens, which indicates an allergic reaction.
      • Normal kidney and liver function, with no significant deviations from normal ranges.
      • Female participants of childbearing potential must have a negative pregnancy test at the screening.

Who cannot join the trial?

4 criteria

  • Participants who do not have birch pollen-induced allergic rhinitis or rhinoconjunctivitis cannot join the study. These are conditions where you have allergy symptoms like a runny nose or itchy eyes caused by birch pollen.
  • Participants who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important to be within the required age group.
  • Participants who are part of a vulnerable population may not be eligible. This means people who might need special protection or care, like children or pregnant women, might not be able to join.
  • Participants who do not meet other specific health criteria set by the study may be excluded. These criteria are not listed here but are important for ensuring the safety and effectiveness of the study.
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Investigated drugs

T502 is a treatment being tested in this clinical trial. It is designed to help people who have allergic reactions to birch pollen, which can cause symptoms like a runny nose, sneezing, and itchy eyes. This treatment is given as an injection under the skin. The goal of using T502 is to reduce the symptoms of allergies and the need for other allergy medications during the time of year when birch pollen is most common. By participating in this trial, researchers hope to see if T502 can make a noticeable difference in how people feel during the birch pollen season compared to those who do not receive the treatment.

What is already known about the treatment

T502 – T502 is a medication administered through injections under the skin, specifically designed for people suffering from allergies caused by birch pollen. It is currently being studied in clinical trials to determine its effectiveness in reducing symptoms like sneezing and itchy eyes, as well as the need for other allergy medications during the birch pollen season. The main therapeutic use of T502 is to treat allergic rhinitis and rhinoconjunctivitis triggered by birch pollen. At the molecular level, T502 works by modifying the immune system's response to birch pollen, potentially reducing allergic reactions. It is classified as an immunotherapy treatment, which aims to train the immune system to better handle allergens.

Investigated diseases

  • Allergic Rhinitis

    Allergic rhinitis is an inflammation of the nasal passages caused by an allergic reaction to airborne substances, such as pollen. It is characterized by symptoms like sneezing, nasal congestion, runny nose, and itching. The condition is triggered when the immune system overreacts to allergens, leading to the release of histamines and other chemicals. Over time, repeated exposure to allergens can cause persistent symptoms and may lead to complications such as sinusitis. The severity of symptoms can vary depending on the level of exposure to allergens. It is often seasonal, especially when related to pollen, but can also be perennial if caused by indoor allergens.

  • Allergic Rhinoconjunctivitis

    Allergic rhinoconjunctivitis is a condition that involves both allergic rhinitis and conjunctivitis, affecting the nasal passages and eyes. It is triggered by allergens such as pollen, dust mites, or pet dander, leading to symptoms like sneezing, nasal congestion, runny nose, itchy and watery eyes. The immune system's response to these allergens causes inflammation in both the nasal passages and the conjunctiva of the eyes. Over time, exposure to allergens can lead to persistent symptoms and discomfort. The condition can be seasonal, particularly with pollen exposure, or perennial with other allergens. Symptoms can vary in intensity based on the level of allergen exposure.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515717-17-00Protocol codeT502-SIT-073Estimated enrolment360 patientsSponsorInmunotek S.L.

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