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Study on the Effectiveness and Safety of Beltavac for Patients with Allergic Rhinitis from House Dust Mites

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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 for allergic rhinitis and rhinoconjunctivitis caused by exposure to house dust mites. The treatment being tested is called BELTAVAC, which is an injectable solution containing a mixture of allergen extracts from house dust mites, specifically Dermatophagoides pteronyssinus and Dermatophagoides farinae, combined with a substance called glutaraldehyde. This study will also use a placebo, which is a saline solution without the allergenic extract.

The purpose of the study is to evaluate the effectiveness and safety of this treatment when given as a subcutaneous injection, which means it is injected under the skin. Participants will receive the treatment over a period of 12 months. The study aims to see if this treatment can help reduce the symptoms of allergic rhinitis, which include sneezing, runny or blocked nose, and itchy eyes, among others.

Throughout the study, participants will be asked to keep track of their symptoms and any medication they use in an online patient diary. This will help researchers understand how well the treatment is working. The study will also look at how many days participants can go without symptoms or needing medication. The results will help determine if BELTAVAC is a safe and effective option for people with allergies to house dust mites.

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 visit and consent

    Upon joining the clinical trial, the first step involves an initial visit where informed consent is obtained. This means signing a document that explains the trial and confirms understanding and willingness to participate.

    During this visit, eligibility is confirmed based on age, symptoms of allergic rhinitis, and a positive test for house dust mite sensitivity.

  2. Step 2

    Screening phase

    The screening phase lasts for 4 weeks. During this time, an electronic patient record is maintained to track symptoms and medication use.

    For women who can become pregnant, a negative pregnancy test is required, and contraception must be used for at least one month before the visit and throughout the trial.

  3. Step 3

    Treatment phase

    The treatment phase involves receiving subcutaneous injections of Beltavac, which contains a polymerized extract of house dust mites. This phase lasts for 12 months.

    Injections are administered under the skin, and the frequency and dosage are determined by the study protocol.

  4. Step 4

    Monitoring and recording

    Throughout the trial, daily records of nasal symptoms and medication use are maintained in an online patient card.

    Regular assessments are conducted to evaluate the effectiveness and safety of the treatment.

  5. Step 5

    Follow-up and evaluation

    The trial includes periodic follow-up visits to monitor progress and any side effects.

    The primary goal is to assess the improvement in symptoms and the reduction in medication use over the course of the year.

Who can join the trial?

11 criteria

  • Provide a signed and dated written consent to participate.
  • Be a male or female aged between 12 and 65 years.
  • Have moderate or severe symptoms of ongoing rhinitis (a condition causing a runny or stuffy nose) as per the ARIA Guide, with or without asthma that is well or partially controlled according to the GEMA Guide.
  • Show confirmation of sensitivity to house dust mites through a positive skin prick test (a test where a small amount of allergen is placed on the skin to check for a reaction) with a wheal (raised, red area) of 3 mm or more, and a specific IgE (a type of antibody) level of class 3 or higher within 6 months before the study.
  • If female and capable of becoming pregnant, use contraception for at least 1 month before the study and agree to continue using it during the study.
  • Be willing and able to complete an electronic patient record during the 4-week screening period.
  • For the treatment phase, have a negative pregnancy test.
  • Have a combined symptom and medication score (ESMR4) of 1.5 or higher during the screening phase.
  • Be willing and able to complete an electronic patient record for a 12-week period during the treatment phase.
  • For patients with asthma, have an Asthma Control Test (ACT) score greater than 19.
  • For patients with asthma, have a Peak Expiratory Flow (PEF) value greater than 80% of their personal best at the time of the visit.

Who cannot join the trial?

7 criteria

  • Patients who have a severe allergy to the treatment being tested.
  • Patients with a history of severe allergic reactions, known as anaphylaxis, which is a serious and potentially life-threatening reaction.
  • Patients who are currently taking medications that could interfere with the study treatment.
  • Patients with any other medical condition that the study doctors believe could make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

Beltavac® is a type of treatment called subcutaneous immunotherapy. It is designed to help people who are allergic to house dust mites. This therapy involves injecting a small amount of a special mixture under the skin. The mixture contains allergenic extracts from house dust mites that have been modified to be less likely to cause a strong allergic reaction. The goal of this treatment is to gradually train the immune system to become less sensitive to these allergens, which can help reduce symptoms like sneezing, runny nose, and itchy eyes. This process is sometimes referred to as "rush immunotherapy" because it aims to achieve results more quickly than traditional methods. The treatment is given over a period of 12 months to help manage symptoms of allergic rhinitis or rhinoconjunctivitis, which are conditions that affect the nose and eyes.

What is already known about the treatment

Beltavac® – Beltavac® is administered through subcutaneous injections, meaning it is given as a shot under the skin. It is currently being studied in clinical trials to evaluate its effectiveness and safety for treating allergic rhinitis and rhinoconjunctivitis caused by house dust mites. The main therapeutic use of Beltavac® is to help reduce symptoms of allergies, such as sneezing and itchy eyes, by gradually desensitizing the immune system to allergens. At the molecular level, it works by using a polymerized allergenic extract to modify the immune response, making it less sensitive to house dust mites. Beltavac® is classified as an immunotherapy medication, which is a type of treatment that helps the immune system respond better to allergens.

Investigated diseases

Allergic rhinoconjunctivitis due to exposure of house dust mites – This condition is an allergic reaction that affects the nose and eyes, triggered by exposure to house dust mites. It involves inflammation of the nasal passages and conjunctiva, the membrane covering the eyes. Symptoms typically include sneezing, nasal congestion, runny nose, itchy eyes, and watery eyes. The condition progresses with repeated exposure to allergens, leading to persistent or worsening symptoms. Over time, individuals may experience increased sensitivity to other allergens. The severity of symptoms can vary depending on the level of exposure and individual sensitivity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516893-31-01Protocol codePRO-RCT-ACAROS-2018Estimated enrolment250 patientsSponsorProbelte Pharma S.L.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).