Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Study on the Effectiveness and Safety of PQ Birch for Patients with Seasonal Allergic Rhinitis or Rhinoconjunctivitis from Birch Pollen

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 treatment called Pollinex Quattro Plus 1.0 mL Birch for people who experience seasonal allergic rhinitis and/or rhinoconjunctivitis due to exposure to birch pollen. Seasonal allergic rhinitis is commonly known as hay fever, which causes symptoms like sneezing, a runny or blocked nose, and itchy eyes. Rhinoconjunctivitis includes these symptoms along with eye irritation. The treatment being tested is given as a subcutaneous injection, which means it is injected under the skin.

The purpose of this study is to evaluate how effective and safe the PQ Birch treatment is for individuals affected by birch pollen allergies. Participants in the study will receive either the PQ Birch treatment or a placebo, which is a substance with no active medication. The study is designed to be randomised and double-blind, meaning neither the participants nor the researchers know who is receiving the actual treatment or the placebo, to ensure unbiased results.

Throughout the study, participants will attend several visits where they will receive injections and have their health monitored. The study will last for a period of time that includes the birch pollen season, allowing researchers to observe the treatment's effects during peak allergy times. The main goal is to see if the treatment can reduce the symptoms of hay fever and improve the quality of life for those affected by birch pollen allergies.

The research process

The trial runs in 6 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, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination to ensure you meet the trial's health criteria.

    You will be asked to provide informed consent, which means you agree to participate in the trial after understanding its purpose, procedures, and potential risks.

  2. Step 2

    Screening tests

    You will undergo several screening tests to confirm your eligibility. These tests include a blood test to measure your birch-specific IgE levels and a lung function test to assess your breathing capacity.

    A skin prick test will be performed to check your reaction to birch pollen and other substances.

  3. Step 3

    Randomization

    If you qualify for the trial, you will be randomly assigned to receive either the investigational treatment, Pollinex Quattro Plus 1.0 mL Birch, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the investigational treatment.

  4. Step 4

    Treatment administration

    You will receive the assigned treatment through a subcutaneous injection, which means the injection is given under the skin. The treatment will be administered according to the trial schedule, which will be explained to you by the healthcare team.

    The frequency and duration of the treatment will be specified during your visits.

  5. Step 5

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and the effects of the treatment. During these visits, you may undergo physical examinations, blood tests, and other assessments as required by the trial protocol.

    Your symptoms and any side effects will be recorded to evaluate the safety and efficacy of the treatment.

  6. Step 6

    End of treatment

    At the end of the treatment period, you will have a final visit to assess your overall health and the outcomes of the trial.

    You may be asked to provide feedback on your experience and any changes in your symptoms.

Who can join the trial?

10 criteria

  • Capable of giving signed informed consent, which means you understand the study and agree to follow its rules and attend required visits.
  • Have a birch-specific IgE level of 0.71 kUA/L or higher, as shown by a blood test. IgE is a type of antibody that your body makes in response to allergens.
  • Have a forced expiratory volume in one second (FEV1) and peak expiratory flow rate (PEFR) that are both 70% or more of what is expected for your age and size. These are tests that measure how well your lungs are working.
  • Be between 18 and 65 years old at the time of signing the consent form.
  • Can be male or female.
  • If you are a female, you must either not be able to have children or agree to use birth control as required by the study.
  • Be in good general health, as determined by the study doctor, based on your medical history, physical exam, mental health assessment, and lab tests.
  • Have a history of moderate to severe symptoms of seasonal allergic rhinitis or rhinoconjunctivitis due to birch pollen for at least 2 years, even after using allergy medications like antihistamines or nasal sprays.
  • Have a positive skin prick test (SPT) to histamine, which means your skin reacts to a small amount of histamine, and a negative reaction to a control substance.
  • Have a positive skin prick test for birch pollen, which means your skin reacts to a small amount of birch pollen.

Who cannot join the trial?

8 criteria

  • Patients who do not have seasonal allergic rhinitis (a type of allergy that affects the nose) or rhinoconjunctivitis (an allergy that affects both the nose and eyes) caused by birch pollen cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of severe allergic reactions cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to any component of the study medication cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

PQ Birch is a treatment being tested for people who have allergies to birch pollen. This medication is designed to help reduce the symptoms of seasonal allergic rhinitis, which is a condition that causes sneezing, a runny or stuffy nose, and itchy eyes when exposed to birch pollen. The goal of this treatment is to make it easier for people to manage their allergy symptoms during the birch pollen season.

What is already known about the treatment

PQ Birch – PQ Birch is administered as an oral medication, specifically designed to help people who suffer from seasonal allergic rhinitis and rhinoconjunctivitis caused by birch pollen. Currently, it is being studied in clinical trials to assess its effectiveness and safety, and it is not yet widely available in medical practice. The main purpose of this medication is to alleviate symptoms like sneezing, runny nose, and itchy eyes that occur during birch pollen season. It works by modulating the immune system's response to birch pollen, helping to reduce the allergic reaction. PQ Birch falls under the category of allergy immunotherapy treatments.

Investigated diseases

Seasonal Allergic Rhinitis – Seasonal allergic rhinitis is an inflammatory condition affecting the nasal passages, triggered by allergens such as pollen. It is characterized by symptoms like sneezing, nasal congestion, runny nose, and itching. The condition typically occurs during specific seasons when pollen levels are high. As the exposure to allergens continues, symptoms may persist or worsen. The inflammation can also affect the eyes, leading to itching and redness, a condition known as rhinoconjunctivitis. The progression of symptoms is closely linked to the duration and intensity of allergen exposure.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507427-28-00Protocol codePQBirch302Estimated enrolment562 patientsSponsorAllergy Therapeutics (UK) Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.