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Efficacy and safety of house dust mite allergoid (Dermatophagoides farinae, D. pteronyssinus, aluminium hydroxide) in people with moderate to severe house dust mite allergy

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What is this trial about?

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

People who are sensitive to house dust mite allergy often suffer from allergic rhinitis (runny or blocked nose), rhinoconjunctivitis (sneezing and itchy eyes), and sometimes have asthma (breathing difficulties). The study tests a new treatment that is given by an injection under the skin (subcutaneous) and contains a specially altered form of dust‑mite proteins called an allergoid. This injection is compared with a placebo that looks the same but does not contain the active dust‑mite proteins.

The purpose of the trial is to find out whether the dust‑mite allergoid injection reduces symptoms better than the placebo after about one year of treatment. Participants will receive a series of injections over several months, followed by a short period of observation to record daily symptom scores, use of allergy medicines, and any side effects. Simple terms such as “subcutaneous” mean the medicine is given just under the skin, and “allergoid” refers to a protein that has been modified to trigger a milder immune response, helping the body become less reactive to the allergen.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline evaluation phase

    For the first two weeks after joining the study you will keep a daily symptom diary. each day you record how your nose, eyes and breathing feel and any allergy medication you use.

    You continue to take your usual background medication: desloratadine 5 mg tablet taken by mouth once daily, levocabastine eye drops (30 µg per dose) used as needed in each eye, and mometasone nasal spray (200 µg per actuation) used once daily.

    The purpose of this period is to collect information about your symptoms before any study injections are given.

  2. Step 2

    First study injection

    After the baseline period you will visit the clinic for the first subcutaneous injection. the injection is given under the skin in the upper arm.

    The injection contains either the active allergen preparation (house dust mite allergoid) or a placebo that looks the same but does not contain the allergen. the dose is 6000 U (unit) per injection.

    You will be observed for a short time after the injection to check for any immediate reaction.

  3. Step 3

    Regular injection visits during buildup phase

    For the first several weeks you will return to the clinic about once a week for additional subcutaneous injections of the same dose (6000 U).

    Each visit includes the injection, a brief health check, and a review of any side effects you may have experienced.

    You continue to take your background medication as before and keep recording daily symptoms.

  4. Step 4

    Maintenance phase injections

    Once the weekly buildup period is completed, injections are given less often, typically once a month, until approximately 12 months after the first injection.

    The dose remains 6000 U per injection, and the same observation procedures are followed at each visit.

    You keep using your background medication and completing the daily symptom diary throughout this phase.

  5. Step 5

    Safety and laboratory monitoring

    At each injection visit the study staff will ask about any adverse events (side effects) and may perform simple tests such as blood sampling, lung function measurement, and vital‑sign checks.

    These assessments help determine whether the study treatment is safe for you.

  6. Step 6

    Efficacy evaluation phase

    After the final injection (around month 12) you enter a 4‑week period where no further injections are given.

    During these four weeks you continue to fill out the daily symptom diary and use your background medication as needed.

    The study team will collect the diary information and may perform a final set of blood tests and lung‑function measurements.

  7. Step 7

    Final study visit

    At the end of the 4‑week evaluation you attend a final clinic visit.

    You will complete questionnaires about quality of life and overall tolerability, give a blood sample to measure specific allergy antibodies, and undergo a last lung‑function check.

    After this visit your participation in the trial is complete.

Who can join the trial?

10 criteria

  • Written informed consent must be signed by the patient (and by a parent or legal guardian if the patient is a minor) before any study procedures begin.
  • The patient (or parent/guardian) must be willing and able to fill out an electronic patient record during the initial baseline period and the later evaluation period.
  • The patient must be between 12 and 65 years old at the time they sign the consent.
  • The patient must have a medical history of allergic nasal symptoms caused by house dust mite that are driven by IgE antibodies (a type of immune protein), with or without related asthma.
  • A positive skin prick test (SPT) to one of the dust‑mite allergens (Dermatophagoides pteronyssinus or D. farinae) is required. This means a small skin bump (called a wheal) of at least 3 mm appears after the allergen is applied, the control test with histamine also makes a wheal of at least 3 mm, and the saline (NaCl) control shows a wheal smaller than 2 mm.
  • The patient must have an immunoassay result showing a level of specific IgE of 0.70 kU/L or higher to the dust‑mite allergens.
  • The patient must have a history of persistent, moderate‑to‑severe allergic rhinitis (nasal allergy) as defined by the ARIA guidelines, meaning symptoms lasted at least four weeks in a row, occurred on at least four days each week, and were troublesome or interfered with daily activities or sleep.
  • The patient must have needed regular use of allergy‑relief medication for at least one year before starting the study.
  • The patient must score 5 or higher on the house dust mite questionnaire (HDMQ), which measures the impact of dust‑mite allergy.
  • During a 14‑day baseline period, the patient must record symptoms on at least 11 days, have at least 8 days with a total nasal symptom score of 6 or higher (or a score of 5 with at least one severe symptom), and document use of rescue medication (extra medication taken when symptoms get worse) on at least 8 days.

Who cannot join the trial?

28 criteria

  • Cannot understand what the trial involves, give proper consent, or follow the study rules.
  • Has allergies to other things (such as pets, mould, cockroaches, storage mites, or certain pollens) that cause symptoms during the study periods, and tests show a positive reaction (a skin prick test with a bump at least 3 mm or a blood test showing IgE ≥ 0.70 kU/L).
  • Has a higher level of specific IgE (an allergy‑related antibody) to storage mites than to house dust mites.
  • Has ongoing chronic nasal or breathing problems that are not caused by allergies.
  • Has nasal conditions that could affect the study results, such as enlarged tonsils, nasal polyps, or a history of sinus or nasal surgery.
  • Has permanent lung damage (for example, emphysema or bronchiectasis).
  • Has lung function measured as FEV1 (the amount of air forced out in one second) less than 70 % of the normal predicted value, even with good asthma treatment.
  • Has asthma that is not well‑controlled or only partly controlled according to standard guidelines (GINA).
  • Has severe asthma (step 4 or 5 on the GINA scale) that needs medium‑ or high‑dose inhaled steroid combos or additional biologic drugs.
  • Had an asthma flare‑up in the last 6 months that required an unscheduled doctor visit, hospital stay, or use of oral steroids.
  • Has serious acute or chronic illnesses (such as chronic hives, mastocytosis, active tuberculosis, type 1 diabetes, cancer, severe kidney or liver disease) or a fever‑producing infection.
  • Is currently in another clinical trial or was in one within 30 days before signing the consent form.
  • Has autoimmune or immune‑deficiency diseases (e.g., HIV, organ‑transplant status, lupus, vitiligo, Graves disease, multiple sclerosis).
  • Has severe psychiatric or psychological disorders that could interfere with giving consent or following study procedures.
  • Has recurrent seizures or untreated epilepsy.
  • Has laboratory test results that are more abnormal than a mild (grade 1) level according to FDA guidelines, except that higher eosinophil counts are allowed because they indicate allergy.
  • Is currently taking β‑blockers (medicines that lower heart rate) or ACE inhibitors (medicines that lower blood pressure).
  • Has conditions that make the use of epinephrine (a medication used for severe allergic reactions) unsafe, such as active heart disease or very high blood pressure.
  • Has used biologic therapies that affect immune tolerance (such as anti‑IgE or other type‑2 inflammation drugs) within the last 6 months before the first dose and during the trial.
  • Has taken antidepressants or antipsychotic drugs that also act like antihistamines within the last 6 months and during the trial.
  • Is allergic to any inactive ingredients (excipients) in the study medication.
  • Has already been randomly assigned to this trial before.
  • Is an employee of the sponsor, contract research organization, or study site, or has a dependent relationship that could affect voluntary participation.
  • Is institutionalized by an official or court order.
  • For women: is pregnant, breastfeeding, planning to become pregnant, or is of child‑bearing age and sexually active without using a highly effective birth‑control method (failure rate < 1 % per year).
  • Has a confirmed severe allergic reaction (anaphylaxis) after a previous allergy injection therapy.
  • Is currently receiving any allergy immunotherapy (AIT) or had it within the last 12 months before screening.
  • Received house‑dust‑mite allergy immunotherapy within the last 5 years.
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Investigated drugs

  • Desloratadine

    is an oral antihistamine tablet that helps relieve sneezing, runny nose, and itchy eyes caused by allergies. In this study, participants took it as part of their usual allergy care so researchers could see how the new dust‑mite treatment worked on top of standard medication.

  • HOUSE DUST MITES

    is a subcutaneous (under the skin) injection that contains modified proteins from two common dust‑mite species (Dermatophagoides pteronyssinus and Dermatophagoides farinae) along with an ingredient that helps stimulate the immune system. This is the investigational product being tested to see if it can reduce symptoms of allergic rhinitis and related asthma when given regularly over about a year.

  • Levocabastine

    eye drops are a suspension that you place in the eyes to reduce itching, redness, and watery discharge caused by allergic reactions. In the trial, they were used by participants who needed additional relief for eye symptoms while the main dust‑mite injection was being evaluated.

  • Mometasone Furoate

    nasal spray is a corticosteroid spray that you spray into the nose to decrease swelling and inflammation, helping to ease nasal congestion, sneezing, and runny nose. It was allowed as background therapy so participants could continue their usual nasal steroid treatment during the study.

What is already known about the treatment

  • Desloratadine

    This medication is taken as a 5 mg film‑coated tablet taken by mouth. It is an approved, widely used second‑generation antihistamine that treats allergic rhinitis and hives. It works by blocking H1 histamine receptors, which stops the usual itching, sneezing and watery eyes caused by histamine. It is classified as an oral antihistamine.

  • Levocabastine

    The drug is supplied as 0.5 mg/mL eye‑drop suspension applied directly to the eyes. It is a prescription antihistamine used for allergic conjunctivitis, relieving itchy and red eyes. It blocks H1 receptors on the eye surface, preventing histamine from causing inflammation. It belongs to the class of topical H1‑antagonist eye drops.

  • Mometasone furoate

    This product is a nasal spray delivering 50 µg per actuation, used by spraying into the nostrils. It is an approved prescription corticosteroid for treating allergic rhinitis and nasal congestion. It reduces swelling by binding to glucocorticoid receptors and lowering inflammatory chemicals. It is classified as an intranasal corticosteroid.

  • House dust mite allergoid

    The investigational drug is given as a subcutaneous injection containing modified Dermatophagoides farinae and Dermatophagoides pteronyssinus allergens with aluminium hydroxide, at a dose of 6000 U per injection. It is currently being studied in clinical trials as an allergen immunotherapy for house‑dust‑mite‑induced allergic rhinitis and asthma. It works by slowly training the immune system to tolerate the allergens, shifting the response from an allergic IgE pattern to a more tolerant IgG and regulatory cell pattern. It is classified as a subcutaneous allergen immunotherapy (allergoid) preparation.

Investigated diseases

  • House dust mite allergy

    An immune response to proteins from dust mites that occurs when a person inhales or contacts mite particles. Repeated exposure can lead to symptoms such as sneezing, runny nose, itchy eyes, or skin irritation. Symptoms often worsen in environments with high dust accumulation, like bedding or carpets. The reaction can develop at any age and may persist as long as exposure continues.

  • Allergic rhinitis

    Inflammation of the nasal lining triggered by allergens such as pollen, animal dander, or dust mites. It produces sneezing, nasal congestion, a runny nose, and itchy or watery eyes. Symptoms typically start soon after contact with the trigger and can last for the duration of exposure. The condition may be seasonal or occur year‑round depending on the allergen.

  • Asthma

    A chronic disorder in which the airways become narrowed and inflamed, leading to wheezing, shortness of breath, chest tightness, and coughing. Various triggers, including allergens, exercise, cold air, or respiratory infections, can provoke symptoms. The intensity of symptoms can change from day to day and may increase during exposure to specific triggers. The condition is managed by avoiding triggers and using medications, but this description focuses only on its natural course.

Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526213-28-00Protocol codeAL2502acEstimated enrolment492 patients

sourced from the EU Clinical Trials Register and site verification

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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).