Study to Find the Best Dose of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis, with or without Asthma

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What is this study about?

This clinical trial is focused on studying the treatment of allergic rhinoconjunctivitis, which is a condition that causes symptoms like sneezing, runny nose, and itchy eyes due to exposure to grass pollen. The study also includes patients who have asthma along with allergic rhinoconjunctivitis. The treatment being tested is called Beltavac, which is a mixture of grass pollen extracts that have been specially prepared to help reduce allergic reactions. The trial will compare the effects of Beltavac with a placebo to determine the best dose for treating these symptoms.

The purpose of the study is to find the optimal dose of Beltavac for treating allergic rhinoconjunctivitis. Participants in the study will receive injections of either Beltavac or a placebo over a period of 24 weeks. The injections are given under the skin, a method known as subcutaneous injection. Throughout the study, participants will have regular visits to monitor their symptoms and any changes in their condition. The study will also involve tests to measure the body’s response to the treatment, such as checking levels of specific antibodies in the blood.

By the end of the study, researchers aim to see if the treatment with Beltavac can reduce the sensitivity to grass pollen, as measured by a test called the Conjunctival Provocation Test. This test involves exposing the eye to a small amount of allergen to see if it causes a reaction. The study will also look at changes in certain blood markers related to allergies. The results will help determine if Beltavac is effective in reducing symptoms of allergic rhinoconjunctivitis and if it can be a useful treatment option for patients with this condition.

1 initial visit

Upon joining the clinical trial, the first step involves an initial visit. During this visit, a series of assessments will be conducted to confirm eligibility. This includes a review of medical history, a physical examination, and specific tests to confirm the diagnosis of allergic rhinoconjunctivitis caused by grass pollen.

A skin prick test will be performed to check for allergies to grass pollen. Blood samples may be taken to measure specific antibodies related to allergies. If applicable, a conjunctival provocation test will be conducted to assess eye sensitivity to allergens.

2 randomization and treatment allocation

After confirming eligibility, participants will be randomly assigned to receive either the Beltavac treatment or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

The treatment involves receiving a suspension for injection under the skin, known as a subcutaneous injection. The specific dosage and frequency will be determined by the study protocol.

3 treatment phase

During the treatment phase, participants will receive regular subcutaneous injections. The schedule and dosage will be based on the study’s rush regimen, which aims to establish the optimal therapeutic dose of Beltavac.

Participants will be monitored closely for any reactions or side effects. Regular follow-up visits will be scheduled to assess the effectiveness and safety of the treatment.

4 follow-up visits

Throughout the trial, follow-up visits will be conducted to monitor progress. These visits will include assessments of allergy symptoms, lung function tests for those with asthma, and additional blood tests to measure antibody levels.

The primary goal is to evaluate changes in reactivity to allergens and overall symptom improvement.

5 final assessment

At the end of the trial, a final assessment will be conducted. This will involve a comprehensive evaluation of the participant’s response to the treatment, including any changes in allergy symptoms and antibody levels.

The results will contribute to determining the optimal dose of Beltavac for treating allergic rhinoconjunctivitis.

Who Can Join the Study?

Signed and dated Informed Consent Form by a legally competent participant.
Participants must be between the ages of 18 and 65 years old.
Participants should be in good physical and mental health.
Participants must have normal kidney and liver function. If there are any minor deviations, they should be corrected before joining the study.
Females with childbearing potential must agree to use a highly effective method of birth control. This includes options like birth control pills, hormonal devices, intrauterine devices (IUDs), or having a partner who has had a vasectomy. Alternatively, females who cannot have children (due to reasons like menopause or surgery) are also eligible.
Females with childbearing potential must have a negative pregnancy test before starting the study.
Participants must have a diagnosis of grass pollen allergy, confirmed by:
- A history of allergic symptoms for at least the last two pollen seasons.
- A history of moderate to severe symptoms for at least the last two pollen seasons.
- A positive skin test for grass pollen allergens.
- Specific blood tests showing an allergy to grass pollen.
- A positive test showing a Total Symptom Score of 5 or more.
- Use of anti-allergic medication during the last pollen season.
For participants with asthma: they must have a confirmed diagnosis of controlled asthma according to specific guidelines.
For participants with asthma: they must have a lung function test result of at least 80% of their expected value.

Who Cannot Join the Study?

Patients with any other type of allergy besides allergic rhinoconjunctivitis caused by pollen grasses cannot participate. Allergic rhinoconjunctivitis is a condition where the nose and eyes become inflamed due to an allergy.
Patients who are younger than 3 years old or older than 4 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like pregnant women, children, or people with certain disabilities who may need special protection.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Santa Sp. z o.o.	Lodz	Poland
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital De Merida	Merida	Spain
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.	Poznan	Poland
Hfculdwb Uwpsbyioybhzo Dk Lv Pckqwjjp	Madrid	Spain
Huhdbmod Uumicltrnadkx Dm Bclqgkj	Badajoz	Spain
Ptdnhypzut Cglltui Bxtex Pklffjnoofpz I Lrhdmtct Skb z omgp	Warsaw	Poland
Ftecloo Sfa z odqu	Warsaw	Poland
Mvhcht Bswvpxy – Ddesaytfd	Wroclaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not yet recruiting	01.07.2025
Spain	Not yet recruiting	01.07.2025

Trial locations

Investigated drugs:

Beltavac® is a medication used in this clinical trial to help people who suffer from allergic rhinoconjunctivitis, which is a condition that causes symptoms like a runny nose and itchy eyes due to allergies. This medication contains a special mixture made from grass pollen. The grass pollen extract is polymerized, which means it is processed in a way that might help reduce allergic reactions. The goal of using Beltavac® in this trial is to find out the best dose that can help manage the symptoms of allergies, whether or not the person also has asthma. The medication is given in a rush regimen, which means it is administered more quickly than usual to see if it can provide faster relief from allergy symptoms.

Investigated diseases:

Seasonal allergy

Allergic Rhinoconjunctivitis – Allergic rhinoconjunctivitis is an inflammatory condition affecting the nose and eyes, triggered by allergens such as pollen. It is characterized by symptoms like sneezing, nasal congestion, runny nose, itchy eyes, and tearing. The condition occurs 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 discomfort. The severity of symptoms can vary depending on the level of exposure to the allergen. The condition is often seasonal, particularly during times when pollen levels are high.

Trial ID:

2025-520581-22-00

Protocol code:

PRO-RCT-GRAM-2025-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study to Find the Best Dose of Beltavac with Grass Pollen Extract for Patients with Allergic Rhinoconjunctivitis, with or without Asthma

What is this study about?

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Who Cannot Join the Study?