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Study on 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 common allergies that cause symptoms like sneezing, runny nose, and itchy eyes during the birch pollen season. The treatment being tested is a vaccine called mannan-conjugated allergoid (polymerized) Betula pendula parenteral vaccine, which is given as an injection under the skin. The study will compare this vaccine to a placebo, which looks the same but does not contain the active ingredients.

The purpose of the study is to assess how well the vaccine works in reducing allergy symptoms in adolescents and adults who suffer from these conditions. Participants will receive the vaccine or placebo through injections over a period of time. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual vaccine or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored to see how their symptoms change during the peak birch pollen season. The main goal is to determine if the vaccine can effectively reduce the symptoms and the need for other allergy medications. This research could lead to a new way to manage birch pollen allergies and improve the quality of life for those affected by these seasonal conditions.

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 participant will be required to provide a signed and dated informed consent form. For adolescents, both the participant and their parents or legal guardians must sign the consent form.

    Eligibility criteria include being between 12 and 64 years old, being in good health, and having a confirmed diagnosis of birch pollen allergy.

  2. Step 2

    Screening and baseline assessments

    Participants will undergo screening to confirm eligibility, which includes a medical history review, physical examination, and laboratory tests to ensure normal kidney and liver function.

    Female participants of childbearing potential must have a negative pregnancy test.

  3. Step 3

    Treatment administration

    Participants will receive either the mannan-conjugated birch pollen allergoid or a placebo. The treatment is administered as a solution for injection under the skin (subcutaneous).

    The dosage and frequency of administration will be determined by the study protocol, focusing on the treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis.

  4. Step 4

    Monitoring and follow-up

    Participants will be monitored throughout the study to assess the clinical impact of the treatment. This includes regular check-ups and assessments of symptoms and medication use.

    The primary endpoint is the comparison of the Combined Symptom and Medication Score (CSMS) during the peak birch pollen season in 2024 between the placebo and active treatment groups.

  5. Step 5

    Completion of the study

    The study is expected to conclude by May 31, 2024. Participants will have a final assessment to evaluate the overall impact of the treatment.

    Data collected will be used to determine the effectiveness of the treatment in managing symptoms of birch pollen-induced allergic rhinitis or rhinoconjunctivitis.

Who can join the trial?

12 criteria

  • Participants must sign an Informed Consent Form. For adolescents, both the participant and their parents or legal guardians must sign.
  • Participants should be between 12 to 64 years old. In Poland, at least 10% of participants should be aged 12-17. In Germany, participants should be 18-64 years old.
  • Participants must be in good physical and mental health.
  • Participants need to have normal kidney and liver function. If there are minor deviations, they must be retested and show normal results to be eligible.
  • Females who can have children must agree to use a highly effective method of birth control, such as hormonal medications, an intrauterine device (IUD), or other reliable methods. Females who cannot have children, such as those who are post-menopausal or have had certain surgeries, do not need to use birth control.
  • Females who can have children must have a negative pregnancy test at the start of the study.
  • Participants must have a diagnosis of birch pollen allergy, shown by:
    • A history of moderate to severe allergic symptoms for at least two previous birch pollen seasons.
    • A positive skin test for birch pollen allergens.
    • Specific IgE blood test results indicating an allergy to birch pollen.
    • Use of anti-allergic medication for at least two seasons before joining the study.
    • Participants with asthma must have a confirmed diagnosis of controlled asthma according to specific guidelines.
    • Asthmatic participants must have a lung function test result (FEV1 or PEF) that is at least 80% of their expected value.

Who cannot join the trial?

5 criteria

  • Individuals who do not have **birch pollen-induced allergic rhinitis** or **rhinoconjunctivitis**. These are conditions where the nose or eyes become irritated due to birch pollen.
  • Individuals who are not within the specified age range for the study. The study may have specific age requirements.
  • Individuals who are not part of the specified clinical trial groups. The study may be looking for participants with certain characteristics.
  • Individuals who are not male or female, as the study includes both genders.
  • Individuals who are not considered part of a vulnerable population. This means the study may be looking for participants who are in a specific group that needs special protection.
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Investigated drugs

T502 is a treatment being studied for its effects on people with allergic reactions to birch pollen. It is given as an injection under the skin. The goal of this treatment is to help reduce symptoms like sneezing, runny nose, and itchy eyes that are caused by birch pollen allergies.

What is already known about the treatment

Mannan-conjugated birch pollen allergoids – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its effectiveness in treating birch pollen-induced allergic rhinitis or rhinoconjunctivitis. It is not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication is to alleviate symptoms associated with allergies caused by birch pollen. At the molecular level, the mechanism of action involves modifying the immune response to reduce allergic reactions. It is classified pharmacologically as an allergen immunotherapy agent.

Investigated diseases

Allergic Rhinitis – Allergic rhinitis is a condition where the immune system overreacts to allergens in the air, such as pollen, leading to inflammation in the nose. Symptoms include sneezing, itching, nasal congestion, and runny nose. It often occurs seasonally, especially during pollen seasons, but can also be perennial if triggered by indoor allergens. The condition can also affect the eyes, causing itching, redness, and tearing, known as rhinoconjunctivitis. Over time, symptoms may vary in intensity and can be influenced by environmental factors. It is a common condition that can significantly impact quality of life, especially during peak allergen exposure.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508013-16-00Protocol codeT502-SIT-068Estimated enrolment600 patientsSponsorCCDRD Cooperative Clinical Drug Research and Development AG

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