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Study on the Effectiveness of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis 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 the effects of a treatment called Beltavac, which is a mixture of grass pollen extracts, on patients who suffer from allergic rhinoconjunctivitis. This condition is commonly known as hay fever and is caused by an allergic reaction to pollen, leading to symptoms like a runny nose, sneezing, and itchy eyes. Some patients in the study may also have asthma, a condition that affects the airways and can cause breathing difficulties.

The purpose of the study is to determine the best dose of Beltavac for treating allergic rhinoconjunctivitis. Participants will receive the treatment through injections under the skin, known as subcutaneous injections. The study will compare the effects of Beltavac with a placebo, which is an inactive substance, to see how well the treatment works. The study will last for about 24 weeks, during which participants will have regular visits to monitor their symptoms and any changes in their condition.

Throughout the study, participants will be asked to keep a diary using a special app to record their symptoms and any medication they take. This will help researchers understand how the treatment affects their daily lives, especially during the peak pollen season when symptoms are usually at their worst. The study aims to find out if Beltavac can reduce the severity of symptoms and improve the quality of life for people with allergic rhinoconjunctivitis and asthma.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A skin prick test is performed to confirm allergy to grass pollen. A positive result is indicated by a wheal diameter of at least 3 mm.

  2. Step 2

    Baseline visit

    A baseline visit is scheduled to establish initial health parameters. This includes a Conjunctival Provocation Test (CPT) to measure sensitivity to grass pollen.

    A blood test is conducted to measure specific IgE levels against grass pollen allergens.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving subcutaneous injections. The options include a placebo or Beltavac, a polymerized grass pollen extract.

    Injections are administered as a suspension for injection. The frequency and dosage are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health and response to treatment. This includes repeated CPTs to assess changes in sensitivity.

    Participants are required to use a Diary Patient App to record symptoms and any use of rescue medication during the pollen season.

  5. Step 5

    Final assessment

    A final assessment is conducted to evaluate the effectiveness of the treatment. This includes a comparison of CPT results from the baseline and final visits.

    The study concludes with a review of the combined nasal and conjunctival symptoms and medication scores recorded during the peak pollen season.

Who can join the trial?

12 criteria

  • You must sign and date an Informed Consent Form, which is a document that explains the study and confirms your agreement to participate.
  • You should be between 18 and 65 years old.
  • You need to be in good physical and mental health.
  • Your kidney and liver functions should be normal. If there are any minor issues, they should be checked again and be normal before you can join.
  • If you are a woman who can have children, you must agree to use a highly effective method of birth control. This can include options like birth control pills, hormonal devices, an intrauterine device (IUD), or other methods like condoms with spermicide.
  • If you are a woman who can have children, you must have a negative pregnancy test before starting the study.
  • You must have a diagnosis of grass pollen allergy, which includes having a history of allergic symptoms like sneezing and itchy eyes for at least the last two pollen seasons.
  • If you have asthma, it should be controlled according to specific guidelines, and your lung function should be at least 80% of what is expected for you.
  • You need to be willing and able to use a special app to track your symptoms during the pollen season.
  • You must have a positive result on a skin test for grass pollen allergies, which means your skin reacts to the test.
  • You should have specific antibodies in your blood that show you are allergic to grass pollen.
  • You must have a positive result on a test that measures your symptoms when exposed to grass pollen.

Who cannot join the trial?

6 criteria

  • Individuals who have a known allergy to the study medication or its ingredients cannot participate.
  • People with severe or uncontrolled asthma, which is a condition where the airways in the lungs are inflamed and narrowed, making it hard to breathe, are excluded.
  • Participants with any other significant health issues that could interfere with the study or pose a risk to their safety are not eligible.
  • Pregnant or breastfeeding women are not allowed to join the study.
  • Anyone who has participated in another clinical trial within the last 30 days is excluded.
  • Individuals who are unable to comply with the study procedures or follow-up visits cannot take part.
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Investigated drugs

Beltavac: This is a medication used in the trial to help treat allergic rhinoconjunctivitis, which is a condition that causes symptoms like a runny nose and itchy eyes due to allergies. It contains a polymerized extract of grass pollen mixture, which is designed to help the body become less sensitive to grass pollen, potentially reducing allergy symptoms. The trial aims to find the best dose of this medication for patients, whether they also have asthma or not.

What is already known about the treatment

Beltavac – This medication is administered as a rush regimen, which involves giving the treatment in a series of doses over a short period. It is currently being studied in clinical trials to determine the optimal dose for treating allergic rhinoconjunctivitis, which may be associated with asthma. The main therapeutic use of Beltavac is to alleviate symptoms caused by exposure to grass pollen. It works by using a polymerized extract of grass pollen to help the immune system become less sensitive to allergens. Beltavac is classified as an allergen immunotherapy, which is a type of treatment designed to modify the immune response to allergens.

Investigated diseases

Allergic Rhinoconjunctivitis – This condition is an allergic reaction that affects both the nose and eyes, often triggered by exposure to pollen from grasses. It typically manifests with symptoms such as sneezing, nasal congestion, runny nose, itchy eyes, and watery eyes. The symptoms occur when the immune system overreacts to allergens, causing inflammation in the nasal passages and conjunctiva. The condition is usually seasonal, coinciding with the pollen release of specific grasses. Over time, symptoms may vary in intensity and can be influenced by environmental factors. The progression of symptoms can lead to discomfort and may affect daily activities during peak pollen seasons.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510033-28-00Protocol codePRO RCT GRAM 2022Estimated enrolment150 patientsSponsorProbelte Pharma S.L.

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