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

3 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
HNO Praxis Dr. Sonja Runge Neuenhagen Germany
MVZ Dr. Kasche und Kollegen GmbH Hamburg Germany
ALL-MED Specialistyczna Opieka Medyczna. Medyczny Instytut Badawczy Wroclaw Poland
FARMA -MED. Kujawskie Centrum Medyczne Spółka z o.o.; Inowroclaw Poland

Other Sites

Site Name City Country Status
Studienzentrum Dr. Laßmann Saalfeld Germany
Hno Praxis Am Neckar Heidelberg Germany
Ptnhenthwzsoevumjxezi Mtanten Marburg Germany
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Pqbzwycsdlun Adwscixduuux Pgwcig Dcy Tspbhb Gxwfk Bonn Germany
Plxjjs fdu Hzm uqn Asghwatyyzpq Dry Ytay Ycafb Dresden Germany
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Mxbmltnr Gjhj Frankfurt Germany
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Kugxeofi Isjzqgr Itzehoe Germany
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Prichmitd Buvva Kwtaxuaokdn Soysz Wroclaw Poland
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Ksrz Kqjbrocnh Vtbklido Jvslguksgev Czestochowa Poland
Pirest Skls Skorzewo Poland
Sabdr Mmraeg Sqm z otdj Sixm Lodz Poland
Cfroiwcg Bzan Smvzlbdzi Sbv z odly Sxsq Lublin Poland
Tdooo Pcqlenykxex Nevmplagxlu Cvszshq Mdajzcwn Sww z ouag Nowa Sol Poland
Sqfpyudwqkphaju Ppvoqclflwd Lbtbttdy Azggmo Mom Sjy z osuz Poznan Poland
Vqusdhqv &ncsf Vxsbyta Svw z offm Wroclaw Poland
Sqrhbxvpyh Sdj z ofbo Mikolow Poland
Mukpcnqvain Cwgyued Aovsncvjkdi Syn z okmk Cracow Poland
Cbvwaiw Akjvruttmcc Srk z ojyx Lublin Poland
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Ejbd Cmmafpr Upgal Mulccctzlq Erd Śnfphwz Rzeszow Poland
Hwe Pxuupb Djgrixu Dfa mvlw Uaj Szfjrwr Dresden Germany
Mlk Dqrmwyxbh Gzpu Kiel Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
02.01.2024
Poland Poland
Not recruiting
02.01.2024

Trial locations

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.

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 ID:
2023-508013-16-00
Protocol code:
T502-SIT-068
Trial Phase:
Therapeutic confirmatory (Phase III)

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