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Efficacy of subcutaneous modified dust mite allergen extract in adults and children with allergic rhinitis/rhinoconjunctivitis due to house dust mites

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on people who have Allergic rhinitis/rhinoconjunctivitis triggered by exposure to house dust mites. The allergens involved are the tiny insects known as Dermatophagoides pteronyssinus, Dermatophagoides farinae and Blomia tropicalis. The investigational treatment is an injection called Beltavac®, which contains a mixture of these modified allergens, and it will be compared with a placebo injection.

The purpose of the study is to evaluate the effectiveness of the treatment for this type of allergy. Participants will be randomly assigned to receive either the active injection or the placebo, and neither the participants nor the study staff will know which one is given (double‑blind). The injections are given by the subcutaneous route, meaning they are placed just under the skin, and the schedule extends over several months with regular clinic visits.

During the trial, participants will record daily nasal and eye symptoms as well as any allergy medicines taken in a simple diary. Blood samples will be taken at a few visits to measure levels of allergy‑related antibodies such as IgE, which help the body react to allergens. The collected information will be used to determine whether the Beltavac® injection reduces symptoms compared with the placebo.

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

    Enrollment and baseline assessment

    You attend the first study visit, where eligibility is confirmed and written consent is obtained.

    A blood sample is taken to measure allergy‑related antibodies (ige and igg4).

    You complete questionnaires that evaluate nasal and eye symptoms and overall quality of life.

    You receive the first subcutaneous injection of 0.5 ml of the study medication (either the active product or a placebo). the injection is given under the skin.

  2. Step 2

    Daily symptom and medication diary

    You record nasal and eye symptoms and any allergy medication you use each day in an electronic diary.

    The diary is reviewed by the study team every 4 weeks before visits 1 and 7, and every 8 weeks before visit 13.

  3. Step 3

    Regular injection visits

    You return to the clinic at scheduled intervals for additional subcutaneous injections of 0.5 ml.

    Each visit includes a brief safety check and collection of any adverse information.

    The exact interval between injections follows the study protocol but is not disclosed here.

  4. Step 4

    Mid‑study assessment (visit 7)

    You attend visit 7, during which the same questionnaires and blood tests performed at baseline are repeated.

    The visual analogue scale, which measures overall symptom severity, is completed by you and the investigator.

    You continue to receive the 0.5 ml subcutaneous injection at this visit.

  5. Step 5

    Final assessment (visit 13)

    You attend the last study visit, where all questionnaires, blood tests, and the visual analogue scale are completed for the final time.

    The study medication is administered one final time as a 0.5 ml subcutaneous injection.

    The study team reviews the entire symptom diary to evaluate the overall effect of the treatment.

Who can join the trial?

11 criteria

  • You must sign a written informed consent form that explains the study and shows you agree to take part.
  • You must be between 12 and 65 years old, regardless of gender.
  • You must have moderate to severe, persistent rhinitis (nasal allergy) as defined by the ARIA Guidelines, and if you also have asthma, it must be well‑controlled according to the GINA 2025 guidelines (steps 1‑3).
  • You must have a history of allergic rhinitis or rhinoconjunctivitis (nose and eye allergy) that needed treatment for at least one year.
  • You must show a confirmed allergy to house dust mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae, or Blomia tropicalis) by a positive skin prick test (a small bump at least 3 mm) and a blood test with a specific IgE level of class 3 or higher (greater than 3.5 kU/L) performed within the past six months.
  • If you are a woman who could become pregnant, you must use contraception for at least one month before the first visit and agree to continue it throughout the study.
  • You must be willing and able to complete an electronic patient record (online diary) during the 4‑week screening period and the 12‑week treatment period.
  • You must have a negative pregnancy test (if applicable).
  • Your average rhinitis symptom score (RSS) during screening must be 2 or higher.
  • If you have asthma, you must score more than 19 on the Asthma Control Test (ACT), which measures how well your asthma is controlled.
  • If you have asthma, your lung function test called Forced Expiratory Volume in one second (FEV1) must be at least 80% of the normal value.

Who cannot join the trial?

12 criteria

  • Having allergies to other substances besides dust mites (such as pollen, pet dander, or other year‑round allergens) that could cause symptoms and affect the study results.
  • Having mild to severe persistent asthma that is not well‑controlled according to the latest GINA (Global Initiative for Asthma) guidelines.
  • Having an autoimmune disease (where the immune system attacks the body) or an immunodeficiency (a weakened immune system).
  • Having a history of cancer, serious cardiovascular disease (heart problems), serious mental illness, or other long‑term illnesses that could interfere with the study.
  • Having experienced a severe allergic reaction called anaphylaxis that involved breathing or heart problems.
  • Being allergic to any of the inactive ingredients, called excipients, in the study medication.
  • Taking any immunosuppressive medication (for example, cyclosporine A, azathioprine, omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) within the past 6 months and during the study.
  • Taking beta‑blocker medicines during the study period.
  • Having received allergen immunotherapy (allergy shots) that did not work within the last 5 years.
  • Receiving allergy shots for allergens other than dust mites during the study.
  • Receiving any other vaccine within one week before starting the study treatment.
  • Being pregnant or breastfeeding.
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Investigated drugs

Beltavac® is an allergy‑shot treatment given under the skin. It contains tiny amounts of proteins from three common dust‑mite allergens – the house dust mites *Dermatophagoides pteronyssinus* and *Dermatophagoides farinae*, and the tropical mite *Blomia tropicalis*. These proteins have been chemically modified and mixed together to form a stable suspension. In the trial, the shots are used to slowly teach the patient’s immune system to become less reactive to these mites, with the goal of reducing the sneezing, runny nose, itchy eyes and other symptoms of allergic rhinitis or rhinoconjunctivitis. The treatment is given repeatedly over time to build tolerance and improve the patient’s quality of life.

What is already known about the treatment

PLACEBO - The placebo is given as a subcutaneous injection of 0.5 ml of an inert liquid, used only as a control in the study. It contains no active drug and therefore has no therapeutic effect. Placebos are standard tools in clinical trials to help compare the real treatment’s safety and effectiveness. This product is not intended for any medical use outside the trial. Beltavac - Beltavac is administered as a 0.5 ml subcutaneous injection of a suspension containing polymerized extracts of three house‑dust‑mite allergens. It is an approved form of allergen immunotherapy used to treat allergic rhinitis and rhinoconjunctivitis caused by dust‑mite exposure. The modified allergen proteins gently train the immune system, shifting the response from allergy‑driven antibodies to a calmer, protective type and reducing inflammation. It belongs to the pharmacological class of subcutaneous allergen immunotherapy (polymerized allergoid).

Investigated diseases

Allergic rhinitis/rhinoconjunctivitis due to house dust mite exposure - This condition is an allergic reaction that affects the nose and eyes when a person breathes in proteins from common house dust mites. It causes symptoms such as sneezing, a runny or blocked nose, itchy eyes, and watery discharge. The symptoms usually appear shortly after exposure and can become more noticeable as the amount of dust mite allergen in the environment increases. Repeated or continuous exposure may lead to persistent nasal congestion and ongoing eye irritation. Over time, the inflammation can cause the nasal passages to become more sensitive, resulting in a pattern of recurring discomfort that follows the presence of the allergen.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526105-15-00Protocol codePRO-RCT-POL-2026-02Estimated enrolment174 patientsSponsorProbelte Pharma S.L.

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